Robert D. Glatter, MD

This transcript has been edited for clarity.

Robert D. Glatter, MD: Welcome. I’m Dr Robert Glatter, medical adviser for Medscape Emergency Medicine. Today, we have Dr. Paul Pepe, an emergency physician and highly recognized expert in EMS, critical care, and resuscitation, along with Ryan Quinn, EMS chief for Edina Fire Department in Edina, Minn., joining us to discuss a significant advance in resuscitation for patients with nonshockable rhythms in cardiac arrest with a remarkable increase in neurologically intact survival. Welcome, gentlemen.

Dr. Pepe, I’d like to start off by thanking you for taking time to join us to discuss this novel concept of head-up or what you now refer to as a neuroprotective cardiopulmonary resuscitation (CPR) bundle. Can you define what this entails and why it is referred to as a neuroprotective CPR bundle?

Paul E. Pepe, MD, MPH: CPR has been life saving for 60 years the way we’ve performed it, but probably only in a very small percentage of cases. That’s one of the problems. We have almost a thousand people a day who have sudden cardiac arrest out in the community alone and more in the hospital.

We know that early defibrillation and early CPR can contribute, but it’s still a small percentage of those. About 75%-85% of the cases that we go out to see will have nonshockable rhythms and flatlines. Some cases are what we call “pulseless electrical activity,” meaning that it looks like there is some kind of organized complex, but there is no pulse associated with it.

That’s why it’s a problem, because they don’t come back. Part of the reason why we see poor outcomes is not only that these cases tend to be people who, say, were in ventricular fibrillation and then just went on over time and were not witnessed or resuscitated or had a long response time. They basically either go into flatline or autoconvert into these bizarre rhythms.

The other issue is the way we perform CPR. CPR has been lifesaving, but it only generates about 20% and maybe 15% in some cases of normal blood flow, and particularly, cerebral perfusion pressure. We’ve looked at this nicely in the laboratory.

For example, during chest compressions, we’re hoping during the recoil phase to pull blood down and back into the right heart. The problem is that you’re not only setting a pressure rate up here to the arterial side but also, you’re setting back pressure wave on the venous side. Obviously, the arterial side always wins out, but it’s just not as efficient as it could be, at 20% or 30%.

What does this entail? It entails several independent mechanisms in terms of how they work, but they all do the same thing, which is they help to pull blood out of the brain and back into the right heart by basically manipulating intrathoracic pressure and creating more of a vacuum to get blood back there.

It’s so important that people do quality CPR. You have to have a good release and that helps us suck a little bit of blood and sucks the air in. As soon as the air rushes in, it neutralizes the pressure and there’s no more vacuum and nothing else is happening until the next squeeze.

What we have found is that we can cap the airway just for a second with a little pop-up valve. It acts like when you’re sucking a milkshake through a straw and it creates more of a vacuum in the chest. Just a little pop-up valve that pulls a little bit more blood out of the brain and the rest of the body and into the right heart.

We’ve shown in a human study that, for example, the systolic blood pressure almost doubles. It really goes from 40 mm Hg during standard CPR up to 80 mm Hg, and that would be sustained for 14-15 minutes. That was a nice little study that was done in Milwaukee a few years ago.

The other thing that happens is, if you add on something else, it’s like a toilet plunger. I think many people have seen it; it’s called “active compression-decompression.” It not only compresses, but it decompresses. Where it becomes even more effective is that if you had broken bones or stiff bones as you get older or whatever it may be, as you do the CPR, you’re still getting the push down and then you’re getting the pull out. It helps on several levels. More importantly, when you put the two together, they’re very synergistic.

We, have already done the clinical trial that is the proof of concept, and that was published in The Lancet about 10 years ago. In that study, we found that the combination of those two dramatically improved survival rates by 50%, with 1-year survival neurologically intact. That got us on the right track.

The interesting thing is that someone said, “Can we lift the head up a little bit?” We did a large amount of work in the laboratory over 10 years, fine tuning it. When do you first lift the head? How soon is too soon? It’s probably bad if you just go right to it.

We had to get the pump primed a little bit with these other things to get the flow going better, not only pulling blood out of the brain but now, you have a better flow this way. You have to prime at first for a couple of minutes, and we worked out the timing: Is it 3 or 4 minutes? It seems the timing is right at about 2 minutes, then you gradually elevate the head over about 2 minutes. We’re finding that seems to be the optimal way to do it. About 2 minutes of priming with those other two devices, the adjuncts, and then gradually elevate the head over 2 minutes.

When we do that in the laboratory, we’re getting normalized cerebral perfusion pressures. You’re normalizing the flow back again with that. We’re seeing profound differences in outcome as a result, even in these cases of the nonshockables.
 

Dr. Glatter: What you’re doing basically is resulting in an increase in cardiac output, essentially. That really is important, especially in these nonshockable rhythms, correct?

Dr. Pepe: Absolutely. As you’re doing this compression and you’re getting these intracranial pulse waves that are going up because they’re colliding up there. It could be even damaging in itself, but we’re seeing these intracranial raises. The intracranial pressure starts going up more and more over time. Also, peripherally in most people, you’re not getting good flow out there; then, your vasculature starts to relax. The arterials are starting to not get oxygen, so they don’t go out.

With this technique where we’re returning the pressure, we’re getting to 40% of normal now with the active compression-decompression CPR plus an impedance threshold device (ACD+ITD CPR) approach. Now, you add this, and you’re almost normalizing. In humans, even in these asystole patients, we’re seeing end-title CO₂s which are generally in the 15-20 range with standard CPR are now up with ACD+ITD CPR in the 30%-40% range, where we’re getting through 30 or 40 end-tidal CO₂s. Now, we’re seeing even the end-tidal CO₂s moving up into the 40s and 50s. We know there’s a surrogate marker telling us that we are generating much better flows not only to the rest of the body, but most importantly, to the brain.
 

Dr. Glatter: Ryan, could you tell us about the approach in terms of on scene, what you’re doing and how you use the device itself? Maybe you could talk about the backpack that you developed with your fire department?

Ryan P. Quinn, BS, EMS: Our approach has always been to get to the patient quickly, like everybody’s approach on a cardiac arrest when you’re responding. We are an advanced life-support paramedic ambulance service through the fire department – we’re all cross-trained firefighter paramedics. Our first vehicle from the fire department is typically the ambulance. It’s smaller and a little quicker than the fire engine. Two paramedics are going to jump out with two backpacks. One has the automated compressive device (we use the Lucas), and the other one is the sequential patient lifting device, the EleGARD.

Our two paramedics are quick to the patient’s side, and once they make contact with the patient to verify pulseless cardiac arrest, they will unpack. One person will go right to compressions if there’s nobody on compressions already. Sometimes we have a first responder police officer with an automated external defibrillator (AED). We go right to the patient’s side, concentrate on compressions, and within 90 seconds to 2 minutes, we have our bags unpacked, we’ve got the devices turned on, patient lifted up, slid under the device, and we have a supraglottic airway that is placed within 15 seconds already premade with the ITD on top. We have a sealed airway that we can continue to compress with Dr. Pepe’s original discussion of building on what’s previously been shown to work.

Dr. Pepe: Let me make a comment about this. This is so important, what Ryan is saying, because it’s something we found during the study. It’s really a true pit-crew approach. You’re not only getting these materials, which you think you need a medical Sherpa for, but you don’t. They set it up and then when they open it up, it’s all laid out just exactly as you need it. It’s not just how fast you get there; it’s how fast you get this done.

When we look at all cases combined against high-performance systems that had some of the highest survival rates around, when we compare it to those, we found that overall, even if you looked at the ones that had over 20-minute responses, the odds ratios were still three to four times higher. It was impressive.

If you looked at it under 15 minutes, which is really reasonable for most systems that get there by the way, the average time that people start CPR in any system in these studies has been about 8 minutes if you actually start this thing, which takes about 2 minutes more for this new bundle of care with this triad, it’s almost 12-14 times higher in terms of the odds ratio. I’ve never seen anything like that where the higher end is over 100 in terms of your confidence intervals.

Ryan’s system did really well and is one of those with even higher levels of outcomes, mostly because they got it on quickly. It’s like the AED for nonshockables but better because you have a wider range of efficacy where it will work.
 

Dr. Glatter: When the elapsed time was less than 11 minutes, that seemed to be an inflection point in the study, is that correct? You saw that 11-fold higher incidence in terms of neurologically intact survival, is that correct?

Dr. Pepe: We picked that number because that was the median time to get it on board. Half the people were getting it within that time period. The fact that you have a larger window, we’re talking about 13- almost 14-fold improvements in outcome if it was under 15 minutes. It doesn’t matter about the 11 or the 12. It’s the faster you get it on board, the better off you are.

Dr. Glatter: What’s the next step in the process of doing trials and having implementation on a larger scale based on your Annals of Emergency Medicine study? Where do you go from here?

Dr. Pepe: I’ve come to find out there are many confounding variables. What was the quality of CPR? How did people ventilate? Did they give the breath and hold it? Did they give a large enough breath so that blood can go across the transpulmonary system? There are many confounding variables. That’s why I think, in the future, it’s going to be more of looking at things like propensity score matching because we know all the variables that change outcomes. I think that’s going to be a way for me.

The other thing is that we were looking at only 380 cases here. When this doubles up in numbers, as we accrue more cases around the country of people who are implementing this, these numbers I just quoted are going to go up much higher. Unwitnessed asystole is considered futile, and you just don’t get them back. To be able to get these folks back now, even if it’s a small percentage, and the fact that we know that we’re producing this better flow, is pretty striking.

I’m really impressed, and the main thing is to make sure people are educated about it. Number two is that they understand that it has to be done right. It cannot be done wrong or you’re not going to see the differences. Getting it done right is not only following the procedures, the sequence, and how you do it, but it also has to do with getting there quickly, including assigning the right people to put it on and having well-trained people who know what they’re doing.
 

Dr. Glatter: In general, the lay public obviously should not attempt this in the field lifting someone’s head up in the sense of trying to do chest compressions. I think that message is important that you just said. It’s not ready for prime time yet in any way. It has to be done right.

Dr. Pepe: Bystanders have to learn CPR – they will buy us time and we’ll have better outcomes when they do that. That’s number one. Number two is that as more and more systems adopt this, you’re going to see more people coming back. If you think about what we’re doing now, if we only get back 5% of these nonshockable vs. less than 1%, it’s 5% of 800 people a day because a thousand people a day die. Several dozens of lives can be saved on a daily basis, coming back neurologically intact. That’s the key thing.

Dr. Glatter: Ryan, can you comment about your experience in the field? Is there anything in terms of your current approach that you think would be ideal to change at this point?

Mr. Quinn: We’ve established that this is the approach that we want to take and we’re just fine tuning it to be more efficient. Using the choreography of which person is going to do which role, we have clearly defined roles and clearly defined command of the scene so we’re not missing anything. Training is extremely important.

Dr. Glatter: Paul, I want to ask you about your anecdotal experience of people waking up quickly and talking after elevating their heads and going through this process. Having people talk about it and waking up is really fascinating. Maybe you can comment further on this.

Dr. Pepe: That’s a great point that you bring up because a 40- to 50-year-old guy who got saved with this approach, when he came around, he said he was hearing what people were saying. When he came out of it, he found out he had been getting CPR for about 25 minutes because he had persistent recurring ventricular fibrillation. He said, “How could I have survived that that long?”

When we told him about the new approach, he added, “Well, that’s like neuroprotective.” He’s right, because in the laboratory, we showed it was neuroprotective and we’re also getting better flows back there. It goes along with everything else, and so we’ve adopted the name because it is.

These are really high-powered systems we are comparing against, and we have the same level of return of spontaneous circulation. The major difference was when you started talking about the neurointact survival. We don’t have enough numbers yet, but next go around, we’re going to look at cerebral performance category (CPC) – CPC1 vs. the CPC2 – which were both considered intact, but CPC1 is actually better. We’re seeing many more of those, anecdotally.

I also wanted to mention that people do bring this up and say, “Well, let’s do a trial.” As far as we’re concerned, the trial’s been done in terms of The Lancet study 10 years ago that showed that the active compression-decompression had tremendously better outcomes. We show in the laboratories that you augment that a little bit. These are all [Food and Drug Administration] approved. You can go out and buy it tomorrow and get it done. I have no conflicts of interest, by the way, with any of this.

To have this device that’s going to have the potential of saving so many more lives is really an exciting breakthrough. More importantly, we’re understanding more now about the physiology of CPR and why it works. It could work much better with the approaches that we’ve been developing over the last 20 years or so.

Dr. Glatter: Absolutely. I want to thank both of you gentlemen. It’s been really an incredible experience to learn more about an advance in resuscitation that could truly be lifesaving. Thank you again for taking time to join us.

Dr. Glatter is an attending physician in the department of emergency medicine, Lenox Hill Hospital, New York. Dr. Pepe is professor, department of management, policy, and community health, University of Texas Health Sciences Center, Houston. Mr. Quinn is EMS Chief, Edina (Minn.) Fire Department. No conflicts of interest were reported.

A version of this article first appeared Jan. 26 on Medscape.com.

This transcript has been edited for clarity.

Robert D. Glatter, MD: Welcome. I’m Dr Robert Glatter, medical adviser for Medscape Emergency Medicine. Today, we have Dr. Paul Pepe, an emergency physician and highly recognized expert in EMS, critical care, and resuscitation, along with Ryan Quinn, EMS chief for Edina Fire Department in Edina, Minn., joining us to discuss a significant advance in resuscitation for patients with nonshockable rhythms in cardiac arrest with a remarkable increase in neurologically intact survival. Welcome, gentlemen.

Dr. Pepe, I’d like to start off by thanking you for taking time to join us to discuss this novel concept of head-up or what you now refer to as a neuroprotective cardiopulmonary resuscitation (CPR) bundle. Can you define what this entails and why it is referred to as a neuroprotective CPR bundle?

Paul E. Pepe, MD, MPH: CPR has been life saving for 60 years the way we’ve performed it, but probably only in a very small percentage of cases. That’s one of the problems. We have almost a thousand people a day who have sudden cardiac arrest out in the community alone and more in the hospital.

We know that early defibrillation and early CPR can contribute, but it’s still a small percentage of those. About 75%-85% of the cases that we go out to see will have nonshockable rhythms and flatlines. Some cases are what we call “pulseless electrical activity,” meaning that it looks like there is some kind of organized complex, but there is no pulse associated with it.

That’s why it’s a problem, because they don’t come back. Part of the reason why we see poor outcomes is not only that these cases tend to be people who, say, were in ventricular fibrillation and then just went on over time and were not witnessed or resuscitated or had a long response time. They basically either go into flatline or autoconvert into these bizarre rhythms.

The other issue is the way we perform CPR. CPR has been lifesaving, but it only generates about 20% and maybe 15% in some cases of normal blood flow, and particularly, cerebral perfusion pressure. We’ve looked at this nicely in the laboratory.

For example, during chest compressions, we’re hoping during the recoil phase to pull blood down and back into the right heart. The problem is that you’re not only setting a pressure rate up here to the arterial side but also, you’re setting back pressure wave on the venous side. Obviously, the arterial side always wins out, but it’s just not as efficient as it could be, at 20% or 30%.

What does this entail? It entails several independent mechanisms in terms of how they work, but they all do the same thing, which is they help to pull blood out of the brain and back into the right heart by basically manipulating intrathoracic pressure and creating more of a vacuum to get blood back there.

It’s so important that people do quality CPR. You have to have a good release and that helps us suck a little bit of blood and sucks the air in. As soon as the air rushes in, it neutralizes the pressure and there’s no more vacuum and nothing else is happening until the next squeeze.

What we have found is that we can cap the airway just for a second with a little pop-up valve. It acts like when you’re sucking a milkshake through a straw and it creates more of a vacuum in the chest. Just a little pop-up valve that pulls a little bit more blood out of the brain and the rest of the body and into the right heart.

We’ve shown in a human study that, for example, the systolic blood pressure almost doubles. It really goes from 40 mm Hg during standard CPR up to 80 mm Hg, and that would be sustained for 14-15 minutes. That was a nice little study that was done in Milwaukee a few years ago.

The other thing that happens is, if you add on something else, it’s like a toilet plunger. I think many people have seen it; it’s called “active compression-decompression.” It not only compresses, but it decompresses. Where it becomes even more effective is that if you had broken bones or stiff bones as you get older or whatever it may be, as you do the CPR, you’re still getting the push down and then you’re getting the pull out. It helps on several levels. More importantly, when you put the two together, they’re very synergistic.

We, have already done the clinical trial that is the proof of concept, and that was published in The Lancet about 10 years ago. In that study, we found that the combination of those two dramatically improved survival rates by 50%, with 1-year survival neurologically intact. That got us on the right track.

The interesting thing is that someone said, “Can we lift the head up a little bit?” We did a large amount of work in the laboratory over 10 years, fine tuning it. When do you first lift the head? How soon is too soon? It’s probably bad if you just go right to it.

We had to get the pump primed a little bit with these other things to get the flow going better, not only pulling blood out of the brain but now, you have a better flow this way. You have to prime at first for a couple of minutes, and we worked out the timing: Is it 3 or 4 minutes? It seems the timing is right at about 2 minutes, then you gradually elevate the head over about 2 minutes. We’re finding that seems to be the optimal way to do it. About 2 minutes of priming with those other two devices, the adjuncts, and then gradually elevate the head over 2 minutes.

When we do that in the laboratory, we’re getting normalized cerebral perfusion pressures. You’re normalizing the flow back again with that. We’re seeing profound differences in outcome as a result, even in these cases of the nonshockables.
 

Dr. Glatter: What you’re doing basically is resulting in an increase in cardiac output, essentially. That really is important, especially in these nonshockable rhythms, correct?

Dr. Pepe: Absolutely. As you’re doing this compression and you’re getting these intracranial pulse waves that are going up because they’re colliding up there. It could be even damaging in itself, but we’re seeing these intracranial raises. The intracranial pressure starts going up more and more over time. Also, peripherally in most people, you’re not getting good flow out there; then, your vasculature starts to relax. The arterials are starting to not get oxygen, so they don’t go out.

With this technique where we’re returning the pressure, we’re getting to 40% of normal now with the active compression-decompression CPR plus an impedance threshold device (ACD+ITD CPR) approach. Now, you add this, and you’re almost normalizing. In humans, even in these asystole patients, we’re seeing end-title CO₂s which are generally in the 15-20 range with standard CPR are now up with ACD+ITD CPR in the 30%-40% range, where we’re getting through 30 or 40 end-tidal CO₂s. Now, we’re seeing even the end-tidal CO₂s moving up into the 40s and 50s. We know there’s a surrogate marker telling us that we are generating much better flows not only to the rest of the body, but most importantly, to the brain.
 

Dr. Glatter: Ryan, could you tell us about the approach in terms of on scene, what you’re doing and how you use the device itself? Maybe you could talk about the backpack that you developed with your fire department?

Ryan P. Quinn, BS, EMS: Our approach has always been to get to the patient quickly, like everybody’s approach on a cardiac arrest when you’re responding. We are an advanced life-support paramedic ambulance service through the fire department – we’re all cross-trained firefighter paramedics. Our first vehicle from the fire department is typically the ambulance. It’s smaller and a little quicker than the fire engine. Two paramedics are going to jump out with two backpacks. One has the automated compressive device (we use the Lucas), and the other one is the sequential patient lifting device, the EleGARD.

Our two paramedics are quick to the patient’s side, and once they make contact with the patient to verify pulseless cardiac arrest, they will unpack. One person will go right to compressions if there’s nobody on compressions already. Sometimes we have a first responder police officer with an automated external defibrillator (AED). We go right to the patient’s side, concentrate on compressions, and within 90 seconds to 2 minutes, we have our bags unpacked, we’ve got the devices turned on, patient lifted up, slid under the device, and we have a supraglottic airway that is placed within 15 seconds already premade with the ITD on top. We have a sealed airway that we can continue to compress with Dr. Pepe’s original discussion of building on what’s previously been shown to work.

Dr. Pepe: Let me make a comment about this. This is so important, what Ryan is saying, because it’s something we found during the study. It’s really a true pit-crew approach. You’re not only getting these materials, which you think you need a medical Sherpa for, but you don’t. They set it up and then when they open it up, it’s all laid out just exactly as you need it. It’s not just how fast you get there; it’s how fast you get this done.

When we look at all cases combined against high-performance systems that had some of the highest survival rates around, when we compare it to those, we found that overall, even if you looked at the ones that had over 20-minute responses, the odds ratios were still three to four times higher. It was impressive.

If you looked at it under 15 minutes, which is really reasonable for most systems that get there by the way, the average time that people start CPR in any system in these studies has been about 8 minutes if you actually start this thing, which takes about 2 minutes more for this new bundle of care with this triad, it’s almost 12-14 times higher in terms of the odds ratio. I’ve never seen anything like that where the higher end is over 100 in terms of your confidence intervals.

Ryan’s system did really well and is one of those with even higher levels of outcomes, mostly because they got it on quickly. It’s like the AED for nonshockables but better because you have a wider range of efficacy where it will work.
 

Dr. Glatter: When the elapsed time was less than 11 minutes, that seemed to be an inflection point in the study, is that correct? You saw that 11-fold higher incidence in terms of neurologically intact survival, is that correct?

Dr. Pepe: We picked that number because that was the median time to get it on board. Half the people were getting it within that time period. The fact that you have a larger window, we’re talking about 13- almost 14-fold improvements in outcome if it was under 15 minutes. It doesn’t matter about the 11 or the 12. It’s the faster you get it on board, the better off you are.

Dr. Glatter: What’s the next step in the process of doing trials and having implementation on a larger scale based on your Annals of Emergency Medicine study? Where do you go from here?

Dr. Pepe: I’ve come to find out there are many confounding variables. What was the quality of CPR? How did people ventilate? Did they give the breath and hold it? Did they give a large enough breath so that blood can go across the transpulmonary system? There are many confounding variables. That’s why I think, in the future, it’s going to be more of looking at things like propensity score matching because we know all the variables that change outcomes. I think that’s going to be a way for me.

The other thing is that we were looking at only 380 cases here. When this doubles up in numbers, as we accrue more cases around the country of people who are implementing this, these numbers I just quoted are going to go up much higher. Unwitnessed asystole is considered futile, and you just don’t get them back. To be able to get these folks back now, even if it’s a small percentage, and the fact that we know that we’re producing this better flow, is pretty striking.

I’m really impressed, and the main thing is to make sure people are educated about it. Number two is that they understand that it has to be done right. It cannot be done wrong or you’re not going to see the differences. Getting it done right is not only following the procedures, the sequence, and how you do it, but it also has to do with getting there quickly, including assigning the right people to put it on and having well-trained people who know what they’re doing.
 

Dr. Glatter: In general, the lay public obviously should not attempt this in the field lifting someone’s head up in the sense of trying to do chest compressions. I think that message is important that you just said. It’s not ready for prime time yet in any way. It has to be done right.

Dr. Pepe: Bystanders have to learn CPR – they will buy us time and we’ll have better outcomes when they do that. That’s number one. Number two is that as more and more systems adopt this, you’re going to see more people coming back. If you think about what we’re doing now, if we only get back 5% of these nonshockable vs. less than 1%, it’s 5% of 800 people a day because a thousand people a day die. Several dozens of lives can be saved on a daily basis, coming back neurologically intact. That’s the key thing.

Dr. Glatter: Ryan, can you comment about your experience in the field? Is there anything in terms of your current approach that you think would be ideal to change at this point?

Mr. Quinn: We’ve established that this is the approach that we want to take and we’re just fine tuning it to be more efficient. Using the choreography of which person is going to do which role, we have clearly defined roles and clearly defined command of the scene so we’re not missing anything. Training is extremely important.

Dr. Glatter: Paul, I want to ask you about your anecdotal experience of people waking up quickly and talking after elevating their heads and going through this process. Having people talk about it and waking up is really fascinating. Maybe you can comment further on this.

Dr. Pepe: That’s a great point that you bring up because a 40- to 50-year-old guy who got saved with this approach, when he came around, he said he was hearing what people were saying. When he came out of it, he found out he had been getting CPR for about 25 minutes because he had persistent recurring ventricular fibrillation. He said, “How could I have survived that that long?”

When we told him about the new approach, he added, “Well, that’s like neuroprotective.” He’s right, because in the laboratory, we showed it was neuroprotective and we’re also getting better flows back there. It goes along with everything else, and so we’ve adopted the name because it is.

These are really high-powered systems we are comparing against, and we have the same level of return of spontaneous circulation. The major difference was when you started talking about the neurointact survival. We don’t have enough numbers yet, but next go around, we’re going to look at cerebral performance category (CPC) – CPC1 vs. the CPC2 – which were both considered intact, but CPC1 is actually better. We’re seeing many more of those, anecdotally.

I also wanted to mention that people do bring this up and say, “Well, let’s do a trial.” As far as we’re concerned, the trial’s been done in terms of The Lancet study 10 years ago that showed that the active compression-decompression had tremendously better outcomes. We show in the laboratories that you augment that a little bit. These are all [Food and Drug Administration] approved. You can go out and buy it tomorrow and get it done. I have no conflicts of interest, by the way, with any of this.

To have this device that’s going to have the potential of saving so many more lives is really an exciting breakthrough. More importantly, we’re understanding more now about the physiology of CPR and why it works. It could work much better with the approaches that we’ve been developing over the last 20 years or so.

Dr. Glatter: Absolutely. I want to thank both of you gentlemen. It’s been really an incredible experience to learn more about an advance in resuscitation that could truly be lifesaving. Thank you again for taking time to join us.

Dr. Glatter is an attending physician in the department of emergency medicine, Lenox Hill Hospital, New York. Dr. Pepe is professor, department of management, policy, and community health, University of Texas Health Sciences Center, Houston. Mr. Quinn is EMS Chief, Edina (Minn.) Fire Department. No conflicts of interest were reported.

A version of this article first appeared Jan. 26 on Medscape.com.

This transcript has been edited for clarity.

Robert D. Glatter, MD: Welcome. I’m Dr Robert Glatter, medical adviser for Medscape Emergency Medicine. Today, we have Dr. Paul Pepe, an emergency physician and highly recognized expert in EMS, critical care, and resuscitation, along with Ryan Quinn, EMS chief for Edina Fire Department in Edina, Minn., joining us to discuss a significant advance in resuscitation for patients with nonshockable rhythms in cardiac arrest with a remarkable increase in neurologically intact survival. Welcome, gentlemen.

Dr. Pepe, I’d like to start off by thanking you for taking time to join us to discuss this novel concept of head-up or what you now refer to as a neuroprotective cardiopulmonary resuscitation (CPR) bundle. Can you define what this entails and why it is referred to as a neuroprotective CPR bundle?

Paul E. Pepe, MD, MPH: CPR has been life saving for 60 years the way we’ve performed it, but probably only in a very small percentage of cases. That’s one of the problems. We have almost a thousand people a day who have sudden cardiac arrest out in the community alone and more in the hospital.

We know that early defibrillation and early CPR can contribute, but it’s still a small percentage of those. About 75%-85% of the cases that we go out to see will have nonshockable rhythms and flatlines. Some cases are what we call “pulseless electrical activity,” meaning that it looks like there is some kind of organized complex, but there is no pulse associated with it.

That’s why it’s a problem, because they don’t come back. Part of the reason why we see poor outcomes is not only that these cases tend to be people who, say, were in ventricular fibrillation and then just went on over time and were not witnessed or resuscitated or had a long response time. They basically either go into flatline or autoconvert into these bizarre rhythms.

The other issue is the way we perform CPR. CPR has been lifesaving, but it only generates about 20% and maybe 15% in some cases of normal blood flow, and particularly, cerebral perfusion pressure. We’ve looked at this nicely in the laboratory.

For example, during chest compressions, we’re hoping during the recoil phase to pull blood down and back into the right heart. The problem is that you’re not only setting a pressure rate up here to the arterial side but also, you’re setting back pressure wave on the venous side. Obviously, the arterial side always wins out, but it’s just not as efficient as it could be, at 20% or 30%.

What does this entail? It entails several independent mechanisms in terms of how they work, but they all do the same thing, which is they help to pull blood out of the brain and back into the right heart by basically manipulating intrathoracic pressure and creating more of a vacuum to get blood back there.

It’s so important that people do quality CPR. You have to have a good release and that helps us suck a little bit of blood and sucks the air in. As soon as the air rushes in, it neutralizes the pressure and there’s no more vacuum and nothing else is happening until the next squeeze.

What we have found is that we can cap the airway just for a second with a little pop-up valve. It acts like when you’re sucking a milkshake through a straw and it creates more of a vacuum in the chest. Just a little pop-up valve that pulls a little bit more blood out of the brain and the rest of the body and into the right heart.

We’ve shown in a human study that, for example, the systolic blood pressure almost doubles. It really goes from 40 mm Hg during standard CPR up to 80 mm Hg, and that would be sustained for 14-15 minutes. That was a nice little study that was done in Milwaukee a few years ago.

The other thing that happens is, if you add on something else, it’s like a toilet plunger. I think many people have seen it; it’s called “active compression-decompression.” It not only compresses, but it decompresses. Where it becomes even more effective is that if you had broken bones or stiff bones as you get older or whatever it may be, as you do the CPR, you’re still getting the push down and then you’re getting the pull out. It helps on several levels. More importantly, when you put the two together, they’re very synergistic.

We, have already done the clinical trial that is the proof of concept, and that was published in The Lancet about 10 years ago. In that study, we found that the combination of those two dramatically improved survival rates by 50%, with 1-year survival neurologically intact. That got us on the right track.

The interesting thing is that someone said, “Can we lift the head up a little bit?” We did a large amount of work in the laboratory over 10 years, fine tuning it. When do you first lift the head? How soon is too soon? It’s probably bad if you just go right to it.

We had to get the pump primed a little bit with these other things to get the flow going better, not only pulling blood out of the brain but now, you have a better flow this way. You have to prime at first for a couple of minutes, and we worked out the timing: Is it 3 or 4 minutes? It seems the timing is right at about 2 minutes, then you gradually elevate the head over about 2 minutes. We’re finding that seems to be the optimal way to do it. About 2 minutes of priming with those other two devices, the adjuncts, and then gradually elevate the head over 2 minutes.

When we do that in the laboratory, we’re getting normalized cerebral perfusion pressures. You’re normalizing the flow back again with that. We’re seeing profound differences in outcome as a result, even in these cases of the nonshockables.
 

Dr. Glatter: What you’re doing basically is resulting in an increase in cardiac output, essentially. That really is important, especially in these nonshockable rhythms, correct?

Dr. Pepe: Absolutely. As you’re doing this compression and you’re getting these intracranial pulse waves that are going up because they’re colliding up there. It could be even damaging in itself, but we’re seeing these intracranial raises. The intracranial pressure starts going up more and more over time. Also, peripherally in most people, you’re not getting good flow out there; then, your vasculature starts to relax. The arterials are starting to not get oxygen, so they don’t go out.

With this technique where we’re returning the pressure, we’re getting to 40% of normal now with the active compression-decompression CPR plus an impedance threshold device (ACD+ITD CPR) approach. Now, you add this, and you’re almost normalizing. In humans, even in these asystole patients, we’re seeing end-title CO₂s which are generally in the 15-20 range with standard CPR are now up with ACD+ITD CPR in the 30%-40% range, where we’re getting through 30 or 40 end-tidal CO₂s. Now, we’re seeing even the end-tidal CO₂s moving up into the 40s and 50s. We know there’s a surrogate marker telling us that we are generating much better flows not only to the rest of the body, but most importantly, to the brain.
 

Dr. Glatter: Ryan, could you tell us about the approach in terms of on scene, what you’re doing and how you use the device itself? Maybe you could talk about the backpack that you developed with your fire department?

Ryan P. Quinn, BS, EMS: Our approach has always been to get to the patient quickly, like everybody’s approach on a cardiac arrest when you’re responding. We are an advanced life-support paramedic ambulance service through the fire department – we’re all cross-trained firefighter paramedics. Our first vehicle from the fire department is typically the ambulance. It’s smaller and a little quicker than the fire engine. Two paramedics are going to jump out with two backpacks. One has the automated compressive device (we use the Lucas), and the other one is the sequential patient lifting device, the EleGARD.

Our two paramedics are quick to the patient’s side, and once they make contact with the patient to verify pulseless cardiac arrest, they will unpack. One person will go right to compressions if there’s nobody on compressions already. Sometimes we have a first responder police officer with an automated external defibrillator (AED). We go right to the patient’s side, concentrate on compressions, and within 90 seconds to 2 minutes, we have our bags unpacked, we’ve got the devices turned on, patient lifted up, slid under the device, and we have a supraglottic airway that is placed within 15 seconds already premade with the ITD on top. We have a sealed airway that we can continue to compress with Dr. Pepe’s original discussion of building on what’s previously been shown to work.

Dr. Pepe: Let me make a comment about this. This is so important, what Ryan is saying, because it’s something we found during the study. It’s really a true pit-crew approach. You’re not only getting these materials, which you think you need a medical Sherpa for, but you don’t. They set it up and then when they open it up, it’s all laid out just exactly as you need it. It’s not just how fast you get there; it’s how fast you get this done.

When we look at all cases combined against high-performance systems that had some of the highest survival rates around, when we compare it to those, we found that overall, even if you looked at the ones that had over 20-minute responses, the odds ratios were still three to four times higher. It was impressive.

If you looked at it under 15 minutes, which is really reasonable for most systems that get there by the way, the average time that people start CPR in any system in these studies has been about 8 minutes if you actually start this thing, which takes about 2 minutes more for this new bundle of care with this triad, it’s almost 12-14 times higher in terms of the odds ratio. I’ve never seen anything like that where the higher end is over 100 in terms of your confidence intervals.

Ryan’s system did really well and is one of those with even higher levels of outcomes, mostly because they got it on quickly. It’s like the AED for nonshockables but better because you have a wider range of efficacy where it will work.
 

Dr. Glatter: When the elapsed time was less than 11 minutes, that seemed to be an inflection point in the study, is that correct? You saw that 11-fold higher incidence in terms of neurologically intact survival, is that correct?

Dr. Pepe: We picked that number because that was the median time to get it on board. Half the people were getting it within that time period. The fact that you have a larger window, we’re talking about 13- almost 14-fold improvements in outcome if it was under 15 minutes. It doesn’t matter about the 11 or the 12. It’s the faster you get it on board, the better off you are.

Dr. Glatter: What’s the next step in the process of doing trials and having implementation on a larger scale based on your Annals of Emergency Medicine study? Where do you go from here?

Dr. Pepe: I’ve come to find out there are many confounding variables. What was the quality of CPR? How did people ventilate? Did they give the breath and hold it? Did they give a large enough breath so that blood can go across the transpulmonary system? There are many confounding variables. That’s why I think, in the future, it’s going to be more of looking at things like propensity score matching because we know all the variables that change outcomes. I think that’s going to be a way for me.

The other thing is that we were looking at only 380 cases here. When this doubles up in numbers, as we accrue more cases around the country of people who are implementing this, these numbers I just quoted are going to go up much higher. Unwitnessed asystole is considered futile, and you just don’t get them back. To be able to get these folks back now, even if it’s a small percentage, and the fact that we know that we’re producing this better flow, is pretty striking.

I’m really impressed, and the main thing is to make sure people are educated about it. Number two is that they understand that it has to be done right. It cannot be done wrong or you’re not going to see the differences. Getting it done right is not only following the procedures, the sequence, and how you do it, but it also has to do with getting there quickly, including assigning the right people to put it on and having well-trained people who know what they’re doing.
 

Dr. Glatter: In general, the lay public obviously should not attempt this in the field lifting someone’s head up in the sense of trying to do chest compressions. I think that message is important that you just said. It’s not ready for prime time yet in any way. It has to be done right.

Dr. Pepe: Bystanders have to learn CPR – they will buy us time and we’ll have better outcomes when they do that. That’s number one. Number two is that as more and more systems adopt this, you’re going to see more people coming back. If you think about what we’re doing now, if we only get back 5% of these nonshockable vs. less than 1%, it’s 5% of 800 people a day because a thousand people a day die. Several dozens of lives can be saved on a daily basis, coming back neurologically intact. That’s the key thing.

Dr. Glatter: Ryan, can you comment about your experience in the field? Is there anything in terms of your current approach that you think would be ideal to change at this point?

Mr. Quinn: We’ve established that this is the approach that we want to take and we’re just fine tuning it to be more efficient. Using the choreography of which person is going to do which role, we have clearly defined roles and clearly defined command of the scene so we’re not missing anything. Training is extremely important.

Dr. Glatter: Paul, I want to ask you about your anecdotal experience of people waking up quickly and talking after elevating their heads and going through this process. Having people talk about it and waking up is really fascinating. Maybe you can comment further on this.

Dr. Pepe: That’s a great point that you bring up because a 40- to 50-year-old guy who got saved with this approach, when he came around, he said he was hearing what people were saying. When he came out of it, he found out he had been getting CPR for about 25 minutes because he had persistent recurring ventricular fibrillation. He said, “How could I have survived that that long?”

When we told him about the new approach, he added, “Well, that’s like neuroprotective.” He’s right, because in the laboratory, we showed it was neuroprotective and we’re also getting better flows back there. It goes along with everything else, and so we’ve adopted the name because it is.

These are really high-powered systems we are comparing against, and we have the same level of return of spontaneous circulation. The major difference was when you started talking about the neurointact survival. We don’t have enough numbers yet, but next go around, we’re going to look at cerebral performance category (CPC) – CPC1 vs. the CPC2 – which were both considered intact, but CPC1 is actually better. We’re seeing many more of those, anecdotally.

I also wanted to mention that people do bring this up and say, “Well, let’s do a trial.” As far as we’re concerned, the trial’s been done in terms of The Lancet study 10 years ago that showed that the active compression-decompression had tremendously better outcomes. We show in the laboratories that you augment that a little bit. These are all [Food and Drug Administration] approved. You can go out and buy it tomorrow and get it done. I have no conflicts of interest, by the way, with any of this.

To have this device that’s going to have the potential of saving so many more lives is really an exciting breakthrough. More importantly, we’re understanding more now about the physiology of CPR and why it works. It could work much better with the approaches that we’ve been developing over the last 20 years or so.

Dr. Glatter: Absolutely. I want to thank both of you gentlemen. It’s been really an incredible experience to learn more about an advance in resuscitation that could truly be lifesaving. Thank you again for taking time to join us.

Dr. Glatter is an attending physician in the department of emergency medicine, Lenox Hill Hospital, New York. Dr. Pepe is professor, department of management, policy, and community health, University of Texas Health Sciences Center, Houston. Mr. Quinn is EMS Chief, Edina (Minn.) Fire Department. No conflicts of interest were reported.

A version of this article first appeared Jan. 26 on Medscape.com.

This video transcript has been edited for clarity.

Robert D. Glatter, MD: Welcome! I’m Dr Robert Glatter, medical advisor for Medscape Emergency Medicine. Today we have a distinguished panel joining us to discuss an important legal decision resulting in a criminal conviction, involving a medical error due to administration of the wrong medication by a critical care nurse that led to a patient’s death.

Joining us to discuss this case is Dr. Megan Ranney, professor of emergency medicine and the academic dean at Brown University School of Public Health. Also joining us is Dr. Jane Barnsteiner, emeritus professor at the University of Pennsylvania School of Nursing and an expert on patient safety, quality improvement, and system modeling. Welcome to both of you.

Jane Barnsteiner, PhD, RN: Thank you.

Megan L. Ranney, MD, MPH: Thank you. It’s a joy to be with you.

Dr. Glatter: Let’s discuss this very tragic case involving RaDonda Vaught, who was an ICU nurse who was recently convicted in Tennessee of criminally negligent homicide and gross neglect of an impaired adult. She accidentally administered a paralytic medication, vecuronium, instead of a sedative, Versed, which was ordered to sedate a 75-year-old patient who had a brain bleed and TBI. She was scheduled to have a PET scan. After receiving the wrong medication and not really being monitored in any true way, just being in the care of an MRI tech, she suffered cardiac arrest and subsequently died.

Dr. Ranney, I want to begin with you. I saw on Twitter that you had written something that really stuck with me. I’ll quote you. “A culture of safety is one in which the system that allowed the mistake to happen is changed, not one in which the individual is scapegoated. And a culture of safety correlates with better patient outcomes that we know. This verdict is the opposite.”

I’ll let you explain from here. The system issue is the medication dispensing cabinet, in my mind, and there was a medication override. The question is, how was this override allowed to occur in the first place?

Dr. Ranney: My goodness, overrides happen every single day across this country, dozens of times a day in any particular shift. I would think of the system as being much bigger than just the Pyxis or that kind of automated dispensing cabinet, but around the larger system of the verbal orders, the time pressures that the nurse is under, the fact that the nurses are with a trainee, the fact that they’re being asked to operate outside of their normal environment by going down to MRI. There’s a series of issues.

Just as we thought about the Swiss cheese model for COVID-19, that model originated when we talked about patient safety and medical errors. It is a Swiss cheese of circumstances that allows this type of tragic error to occur.

Many of us have worked for years on trying to change the system from one of punishing people, changing it from that punitive system, to rather a system where we can do root-cause analysis, allow people to disclose errors, and allow us to inquire as to what are those series of Swiss cheese holes that allowed this mistake or any other to happen.

When you punish people, you lead them to hide their mistakes instead of allowing them to disclose them and allowing that important inquiry to happen. That’s why this is just so harmful to that culture of safety that so many of us are trying to create.

Dr. Glatter: It’s a chilling verdict in so many ways. I’m right on the same page with you, having worked for so long in the emergency department and seeing nurses that are overtaxed, overburdened, but also on patient floors. This goes to an ICU-type environment where this woman was having a nonemergent head scan and required some sedation.

The question I want to get to is how the system allowed the nurse to dispense this medication —though she was distracted, she’ll admit that. Jane, I want to get to you on this. How can we avoid this? What are the system checks that can be done in some fashion to make this safer and to avoid this tragic error?

Dr. Barnsteiner: First of all, I would say that you do not put in a major change, as they were doing with their EPIC system, as a big bank where you do the change through the entire organization. You do it in one area where you get the whole system smoothed out and all the errors taken care of so that you’re not having a problem like they had through their entire organization, which required overrides multiple times a day.

One of the things that’s been recommended is that these systems, like the Pyxis system, require the first five letters of a medication to be entered into the system so that when you have multiple medications where the first two letters are the same, the chances of pulling out the wrong medication are much smaller.

There’s a question of whether this medication, vecuronium, should have even been in this machine. You can have high-alert medications like this in baggies that have written on the front of the bag, “This is a high-alert medication. It requires two independent double checks.” These are all the things that will help alert the fatigued or distracted nurse or physician and will make things safer. There are many things that can be put into place.

Dr. Glatter: It’s almost like a hard stop. This is a different class of medication. Even if the nurse had a lapse and didn’t realize that, there should have been a hard stop asking whether you want this class. A sedative and a paralytic are two very different medications.

I’m not trying to assign any blame here. I’m just trying to look at mechanics of what happened and how we can put in place methods to avoid these types of errors where a system clearly is overtaxed and overburdened. Is it an artificial intelligence alert? Is it a pharmacy alert that goes out? Is it a Vocera message that gets triggered? It’s something to stop the nurse from doing something where they know better.

She’s used Versed before, apparently, and knows it’s a liquid and doesn’t have to be reconstituted. In my mind, as a practicing doctor for a long time, I see this and I see how it can happen. There are ways I think we can address it. Megan, I want to bring you into this and get your viewpoint.

Dr. Ranney: We’re working in an environment right now — and obviously, this happened pre-COVID — where medicines are constantly in short supply and we’re constantly dealing with substitutions of one for another. This has worsened during COVID, but it existed in the pre-COVID era as well. We’d have time periods where, like today, we’re out of D50 and we have to use D10, or we have a different formulation of a common antibiotic.

I could totally imagine that this nurse had been exposed to multiple medication substitution and so they were rushing; they thought, well, they just put one thing in instead of another and didn’t make that kind of cognitive connection.

What we know so well from our studies of human factors, engineering, and the way that systems work is that when someone is cognitively overloaded and constantly having to think outside the box and make decisions, particularly when they’re exposed to a new system for ordering medicine, there’s only so much that the brain can do at a time. This person was set up for this type of error.

Again, not to say that they didn’t do something wrong. That’s why we have a civil system. That’s why we have licensing. That’s why we have malpractice. To call this a criminal error when they were working within a system that had all these other problems where they were constantly having to make do for system failures, it’s almost inevitable that at some point something really horrible happened.

I’m sorry that it was this nurse, and how horrible for the patient and the family. I’m not excusing that. You can totally imagine, as a practicing physician, nurse, or anyone else in the healthcare system, how this happened.

Dr. Barnsteiner: The other part of it was that they did not have in place, at this time, the barcoding system in this particular patient area. What nurses are used to doing is when they have to pull a medication, they’re using the barcoding system to coordinate with what’s in the electronic health record, with the medication, and with the person’s ID band.

Those are all well-known safety checks that obviously were used to being used by this nurse in the critical care unit but that weren’t available in this MRI area. That is something that absolutely is a system failure. Those kinds of safety systems have to be available at any place in a health system where medications are being delivered.

Dr. Glatter: I think that’s an important point. Here, we have a technology that can supersede the ability of a human to make a mistake, and to have that in place is very critical. I want to go back to the idea of medical malpractice vs homicide charges.

Megan, you made a point of this. This nurse is now an example of someone who went to trial and was convicted, and it could have a chilling effect on healthcare providers. Pre-COVID, post-COVID, it is just chilling. It makes people want to leave the field. It causes PTSD. The psychiatric downstream effects of such an error are just immense.

I don’t know how the district attorney went for criminal charges here. I’m not an attorney and we don’t have a legal expert with us. For this to have happened is just setting precedent that it’s okay to have the effect of making so many people leave the field.

Dr. Ranney: I’m not a lawyer, but I’ve certainly been on the front lines, not only for the past 2 years during COVID but for almost 20 years prior to that. I will say that these types of errors are never-events that sit with our colleagues and friends for their entire career. No one goes into medicine intending to hurt someone. The system fails us and fails the patient.

There are certainly examples of intentional harm, and those people deserve to be prosecuted. This type of thing where a system let them down, again, should require an inquiry of the system. Don’t punish the individuals to the point of putting them in jail.

I think about my last few months working in the emergency department and what my nurses, in particular, have said to me. They worry that they’re going to lose their license and their ability to practice because of the horrific circumstances that we’ve been working in — the understaffing, the lack of access to standard medications, the long wait times, and on and on. They’re not able to take care of patients the way that they’ve been taught to do.

They’re worried already about the downstream effects on their sense of self, as well as on their ability to maintain their livelihood. When you put something like this on top of it, where again, an unintentional error that was potentiated by a somewhat broken system or by a series of Swiss cheese holes that just happened to line up, what message does that send to my nursing colleagues who have stayed on the front lines and who know that they have not been able to provide the standard of care that they’re used to?

Dr. Barnsteiner: On Friday, I did a program on fair and just culture with three health systems and a university school of nursing. Already, some of the faculty reported that students are talking about transferring to another major outside of the School of Nursing because of their worry about this particular guilty verdict.

The other thing is that we already have a tremendous shortage of nurses. We’ve seen many people leave the profession or retire in the past couple of years, and this is only going to compound it further. It is a sobering message that the public can’t afford to have, actually, because this will impact the quality of care and the safety of care that can be delivered to people and families as a result of not having sufficient numbers of professionals to deliver care.

Dr. Glatter: That’s such an important point. In any high-reliability organization, a culture of safety is key. There are tenets we try to adhere to. When we have people leaving the field after seeing a case like this, it’s chilling. We have to re-educate the public and we need to have a realignment of how errors are handled.

This is just the beginning. Her sentencing is going to be in about a month, and we’ll see what happens on reckless homicide charges and neglect. I think there’s going to be a follow-up to this and we’re going to need to discuss this more.

I just wanted to get a couple of takeaways for our audience to just really sear in the brain what we can learn from such an event.

Dr. Ranney: The big takeaway, to me, is the importance of us both continuing to use our voices and working across professional boundaries to help to create this culture of safety, one in which we all feel safe and supported in advocating for systems that work for us. We cannot ask nurses, respiratory technicians, radiology technicians, physicians, or anyone else within the healthcare system to work unsupported, and we have to recognize the degree to which we are all interdependent. My biggest takeaway is for us to use our voices together.

Dr. Barnsteiner: The takeaway that I would have from this, and what I’m working with a number of health systems on, is to have the chair of the board, the CEO of the hospital, the chief medical officer, and the chief nursing officer together promulgate a statement that is sent out to all employees to discuss this verdict and to say what they’re doing to promote a high-reliability organization and a fair and just culture. They should also ask for open conversation and for employees to let the top leadership know any concerns that they have about vulnerabilities in the system. It’s extremely important right now with this verdict that the leaders in healthcare settings, as well as in education settings, let people know what they’ll be doing to protect their employees.

Dr. Glatter: Jane and Megan, I want to thank you so much for such an important discussion that was very informative. I think there’s going to be a follow-up to this that’ll be very, very important. Thanks again.


Robert D. Glatter, MD, is assistant professor of emergency medicine at Lenox Hill Hospital in New York City and at Zucker School of Medicine at Hofstra/Northwell in Hempstead, New York. He is an editorial advisor and hosts the Hot Topics in EM series on Medscape. He is also a medical contributor for Forbes. Dr. Glatter has disclosed no relevant financial relationships.

Megan Ranney, MD, MPH, is professor of emergency medicine and the academic dean at Brown University School of Public Health in Providence, Rhode Island. She is the director and founder of the Brown Emergency Digital Health Innovation (eDHI) program. She is also chief research officer for the American Foundation for Firearm Injury Reduction in Medicine, the country’s only nonprofit committed to reducing firearm injury through the public health approach, and a founding partner of GetUsPPE.org, dedicated to matching donors to health systems in need of protective equipment. Dr. Ranney has disclosed the following relevant financial relationships: Serve(d) as a speaker or a member of a speakers bureau for: Medscape; Merck.

Jane Barnsteiner, PhD, RN, is an emeritus professor at the University of Pennsylvania School of Nursing and an expert on patient safety, quality improvement, and system modeling. In addition to her teaching responsibilities, she was director of translational research at the Hospital of the University of Pennsylvania. Jane was one of the developers of the Quality and Safety in Education for Nurses (QSEN) initiative and is co-editor of Quality and Safety in Nursing: A Competency Based Approach to Improving Outcomes, published by Wiley. She has disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

This video transcript has been edited for clarity.

Robert D. Glatter, MD: Welcome! I’m Dr Robert Glatter, medical advisor for Medscape Emergency Medicine. Today we have a distinguished panel joining us to discuss an important legal decision resulting in a criminal conviction, involving a medical error due to administration of the wrong medication by a critical care nurse that led to a patient’s death.

Joining us to discuss this case is Dr. Megan Ranney, professor of emergency medicine and the academic dean at Brown University School of Public Health. Also joining us is Dr. Jane Barnsteiner, emeritus professor at the University of Pennsylvania School of Nursing and an expert on patient safety, quality improvement, and system modeling. Welcome to both of you.

Jane Barnsteiner, PhD, RN: Thank you.

Megan L. Ranney, MD, MPH: Thank you. It’s a joy to be with you.

Dr. Glatter: Let’s discuss this very tragic case involving RaDonda Vaught, who was an ICU nurse who was recently convicted in Tennessee of criminally negligent homicide and gross neglect of an impaired adult. She accidentally administered a paralytic medication, vecuronium, instead of a sedative, Versed, which was ordered to sedate a 75-year-old patient who had a brain bleed and TBI. She was scheduled to have a PET scan. After receiving the wrong medication and not really being monitored in any true way, just being in the care of an MRI tech, she suffered cardiac arrest and subsequently died.

Dr. Ranney, I want to begin with you. I saw on Twitter that you had written something that really stuck with me. I’ll quote you. “A culture of safety is one in which the system that allowed the mistake to happen is changed, not one in which the individual is scapegoated. And a culture of safety correlates with better patient outcomes that we know. This verdict is the opposite.”

I’ll let you explain from here. The system issue is the medication dispensing cabinet, in my mind, and there was a medication override. The question is, how was this override allowed to occur in the first place?

Dr. Ranney: My goodness, overrides happen every single day across this country, dozens of times a day in any particular shift. I would think of the system as being much bigger than just the Pyxis or that kind of automated dispensing cabinet, but around the larger system of the verbal orders, the time pressures that the nurse is under, the fact that the nurses are with a trainee, the fact that they’re being asked to operate outside of their normal environment by going down to MRI. There’s a series of issues.

Just as we thought about the Swiss cheese model for COVID-19, that model originated when we talked about patient safety and medical errors. It is a Swiss cheese of circumstances that allows this type of tragic error to occur.

Many of us have worked for years on trying to change the system from one of punishing people, changing it from that punitive system, to rather a system where we can do root-cause analysis, allow people to disclose errors, and allow us to inquire as to what are those series of Swiss cheese holes that allowed this mistake or any other to happen.

When you punish people, you lead them to hide their mistakes instead of allowing them to disclose them and allowing that important inquiry to happen. That’s why this is just so harmful to that culture of safety that so many of us are trying to create.

Dr. Glatter: It’s a chilling verdict in so many ways. I’m right on the same page with you, having worked for so long in the emergency department and seeing nurses that are overtaxed, overburdened, but also on patient floors. This goes to an ICU-type environment where this woman was having a nonemergent head scan and required some sedation.

The question I want to get to is how the system allowed the nurse to dispense this medication —though she was distracted, she’ll admit that. Jane, I want to get to you on this. How can we avoid this? What are the system checks that can be done in some fashion to make this safer and to avoid this tragic error?

Dr. Barnsteiner: First of all, I would say that you do not put in a major change, as they were doing with their EPIC system, as a big bank where you do the change through the entire organization. You do it in one area where you get the whole system smoothed out and all the errors taken care of so that you’re not having a problem like they had through their entire organization, which required overrides multiple times a day.

One of the things that’s been recommended is that these systems, like the Pyxis system, require the first five letters of a medication to be entered into the system so that when you have multiple medications where the first two letters are the same, the chances of pulling out the wrong medication are much smaller.

There’s a question of whether this medication, vecuronium, should have even been in this machine. You can have high-alert medications like this in baggies that have written on the front of the bag, “This is a high-alert medication. It requires two independent double checks.” These are all the things that will help alert the fatigued or distracted nurse or physician and will make things safer. There are many things that can be put into place.

Dr. Glatter: It’s almost like a hard stop. This is a different class of medication. Even if the nurse had a lapse and didn’t realize that, there should have been a hard stop asking whether you want this class. A sedative and a paralytic are two very different medications.

I’m not trying to assign any blame here. I’m just trying to look at mechanics of what happened and how we can put in place methods to avoid these types of errors where a system clearly is overtaxed and overburdened. Is it an artificial intelligence alert? Is it a pharmacy alert that goes out? Is it a Vocera message that gets triggered? It’s something to stop the nurse from doing something where they know better.

She’s used Versed before, apparently, and knows it’s a liquid and doesn’t have to be reconstituted. In my mind, as a practicing doctor for a long time, I see this and I see how it can happen. There are ways I think we can address it. Megan, I want to bring you into this and get your viewpoint.

Dr. Ranney: We’re working in an environment right now — and obviously, this happened pre-COVID — where medicines are constantly in short supply and we’re constantly dealing with substitutions of one for another. This has worsened during COVID, but it existed in the pre-COVID era as well. We’d have time periods where, like today, we’re out of D50 and we have to use D10, or we have a different formulation of a common antibiotic.

I could totally imagine that this nurse had been exposed to multiple medication substitution and so they were rushing; they thought, well, they just put one thing in instead of another and didn’t make that kind of cognitive connection.

What we know so well from our studies of human factors, engineering, and the way that systems work is that when someone is cognitively overloaded and constantly having to think outside the box and make decisions, particularly when they’re exposed to a new system for ordering medicine, there’s only so much that the brain can do at a time. This person was set up for this type of error.

Again, not to say that they didn’t do something wrong. That’s why we have a civil system. That’s why we have licensing. That’s why we have malpractice. To call this a criminal error when they were working within a system that had all these other problems where they were constantly having to make do for system failures, it’s almost inevitable that at some point something really horrible happened.

I’m sorry that it was this nurse, and how horrible for the patient and the family. I’m not excusing that. You can totally imagine, as a practicing physician, nurse, or anyone else in the healthcare system, how this happened.

Dr. Barnsteiner: The other part of it was that they did not have in place, at this time, the barcoding system in this particular patient area. What nurses are used to doing is when they have to pull a medication, they’re using the barcoding system to coordinate with what’s in the electronic health record, with the medication, and with the person’s ID band.

Those are all well-known safety checks that obviously were used to being used by this nurse in the critical care unit but that weren’t available in this MRI area. That is something that absolutely is a system failure. Those kinds of safety systems have to be available at any place in a health system where medications are being delivered.

Dr. Glatter: I think that’s an important point. Here, we have a technology that can supersede the ability of a human to make a mistake, and to have that in place is very critical. I want to go back to the idea of medical malpractice vs homicide charges.

Megan, you made a point of this. This nurse is now an example of someone who went to trial and was convicted, and it could have a chilling effect on healthcare providers. Pre-COVID, post-COVID, it is just chilling. It makes people want to leave the field. It causes PTSD. The psychiatric downstream effects of such an error are just immense.

I don’t know how the district attorney went for criminal charges here. I’m not an attorney and we don’t have a legal expert with us. For this to have happened is just setting precedent that it’s okay to have the effect of making so many people leave the field.

Dr. Ranney: I’m not a lawyer, but I’ve certainly been on the front lines, not only for the past 2 years during COVID but for almost 20 years prior to that. I will say that these types of errors are never-events that sit with our colleagues and friends for their entire career. No one goes into medicine intending to hurt someone. The system fails us and fails the patient.

There are certainly examples of intentional harm, and those people deserve to be prosecuted. This type of thing where a system let them down, again, should require an inquiry of the system. Don’t punish the individuals to the point of putting them in jail.

I think about my last few months working in the emergency department and what my nurses, in particular, have said to me. They worry that they’re going to lose their license and their ability to practice because of the horrific circumstances that we’ve been working in — the understaffing, the lack of access to standard medications, the long wait times, and on and on. They’re not able to take care of patients the way that they’ve been taught to do.

They’re worried already about the downstream effects on their sense of self, as well as on their ability to maintain their livelihood. When you put something like this on top of it, where again, an unintentional error that was potentiated by a somewhat broken system or by a series of Swiss cheese holes that just happened to line up, what message does that send to my nursing colleagues who have stayed on the front lines and who know that they have not been able to provide the standard of care that they’re used to?

Dr. Barnsteiner: On Friday, I did a program on fair and just culture with three health systems and a university school of nursing. Already, some of the faculty reported that students are talking about transferring to another major outside of the School of Nursing because of their worry about this particular guilty verdict.

The other thing is that we already have a tremendous shortage of nurses. We’ve seen many people leave the profession or retire in the past couple of years, and this is only going to compound it further. It is a sobering message that the public can’t afford to have, actually, because this will impact the quality of care and the safety of care that can be delivered to people and families as a result of not having sufficient numbers of professionals to deliver care.

Dr. Glatter: That’s such an important point. In any high-reliability organization, a culture of safety is key. There are tenets we try to adhere to. When we have people leaving the field after seeing a case like this, it’s chilling. We have to re-educate the public and we need to have a realignment of how errors are handled.

This is just the beginning. Her sentencing is going to be in about a month, and we’ll see what happens on reckless homicide charges and neglect. I think there’s going to be a follow-up to this and we’re going to need to discuss this more.

I just wanted to get a couple of takeaways for our audience to just really sear in the brain what we can learn from such an event.

Dr. Ranney: The big takeaway, to me, is the importance of us both continuing to use our voices and working across professional boundaries to help to create this culture of safety, one in which we all feel safe and supported in advocating for systems that work for us. We cannot ask nurses, respiratory technicians, radiology technicians, physicians, or anyone else within the healthcare system to work unsupported, and we have to recognize the degree to which we are all interdependent. My biggest takeaway is for us to use our voices together.

Dr. Barnsteiner: The takeaway that I would have from this, and what I’m working with a number of health systems on, is to have the chair of the board, the CEO of the hospital, the chief medical officer, and the chief nursing officer together promulgate a statement that is sent out to all employees to discuss this verdict and to say what they’re doing to promote a high-reliability organization and a fair and just culture. They should also ask for open conversation and for employees to let the top leadership know any concerns that they have about vulnerabilities in the system. It’s extremely important right now with this verdict that the leaders in healthcare settings, as well as in education settings, let people know what they’ll be doing to protect their employees.

Dr. Glatter: Jane and Megan, I want to thank you so much for such an important discussion that was very informative. I think there’s going to be a follow-up to this that’ll be very, very important. Thanks again.


Robert D. Glatter, MD, is assistant professor of emergency medicine at Lenox Hill Hospital in New York City and at Zucker School of Medicine at Hofstra/Northwell in Hempstead, New York. He is an editorial advisor and hosts the Hot Topics in EM series on Medscape. He is also a medical contributor for Forbes. Dr. Glatter has disclosed no relevant financial relationships.

Megan Ranney, MD, MPH, is professor of emergency medicine and the academic dean at Brown University School of Public Health in Providence, Rhode Island. She is the director and founder of the Brown Emergency Digital Health Innovation (eDHI) program. She is also chief research officer for the American Foundation for Firearm Injury Reduction in Medicine, the country’s only nonprofit committed to reducing firearm injury through the public health approach, and a founding partner of GetUsPPE.org, dedicated to matching donors to health systems in need of protective equipment. Dr. Ranney has disclosed the following relevant financial relationships: Serve(d) as a speaker or a member of a speakers bureau for: Medscape; Merck.

Jane Barnsteiner, PhD, RN, is an emeritus professor at the University of Pennsylvania School of Nursing and an expert on patient safety, quality improvement, and system modeling. In addition to her teaching responsibilities, she was director of translational research at the Hospital of the University of Pennsylvania. Jane was one of the developers of the Quality and Safety in Education for Nurses (QSEN) initiative and is co-editor of Quality and Safety in Nursing: A Competency Based Approach to Improving Outcomes, published by Wiley. She has disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

This video transcript has been edited for clarity.

Robert D. Glatter, MD: Welcome! I’m Dr Robert Glatter, medical advisor for Medscape Emergency Medicine. Today we have a distinguished panel joining us to discuss an important legal decision resulting in a criminal conviction, involving a medical error due to administration of the wrong medication by a critical care nurse that led to a patient’s death.

Joining us to discuss this case is Dr. Megan Ranney, professor of emergency medicine and the academic dean at Brown University School of Public Health. Also joining us is Dr. Jane Barnsteiner, emeritus professor at the University of Pennsylvania School of Nursing and an expert on patient safety, quality improvement, and system modeling. Welcome to both of you.

Jane Barnsteiner, PhD, RN: Thank you.

Megan L. Ranney, MD, MPH: Thank you. It’s a joy to be with you.

Dr. Glatter: Let’s discuss this very tragic case involving RaDonda Vaught, who was an ICU nurse who was recently convicted in Tennessee of criminally negligent homicide and gross neglect of an impaired adult. She accidentally administered a paralytic medication, vecuronium, instead of a sedative, Versed, which was ordered to sedate a 75-year-old patient who had a brain bleed and TBI. She was scheduled to have a PET scan. After receiving the wrong medication and not really being monitored in any true way, just being in the care of an MRI tech, she suffered cardiac arrest and subsequently died.

Dr. Ranney, I want to begin with you. I saw on Twitter that you had written something that really stuck with me. I’ll quote you. “A culture of safety is one in which the system that allowed the mistake to happen is changed, not one in which the individual is scapegoated. And a culture of safety correlates with better patient outcomes that we know. This verdict is the opposite.”

I’ll let you explain from here. The system issue is the medication dispensing cabinet, in my mind, and there was a medication override. The question is, how was this override allowed to occur in the first place?

Dr. Ranney: My goodness, overrides happen every single day across this country, dozens of times a day in any particular shift. I would think of the system as being much bigger than just the Pyxis or that kind of automated dispensing cabinet, but around the larger system of the verbal orders, the time pressures that the nurse is under, the fact that the nurses are with a trainee, the fact that they’re being asked to operate outside of their normal environment by going down to MRI. There’s a series of issues.

Just as we thought about the Swiss cheese model for COVID-19, that model originated when we talked about patient safety and medical errors. It is a Swiss cheese of circumstances that allows this type of tragic error to occur.

Many of us have worked for years on trying to change the system from one of punishing people, changing it from that punitive system, to rather a system where we can do root-cause analysis, allow people to disclose errors, and allow us to inquire as to what are those series of Swiss cheese holes that allowed this mistake or any other to happen.

When you punish people, you lead them to hide their mistakes instead of allowing them to disclose them and allowing that important inquiry to happen. That’s why this is just so harmful to that culture of safety that so many of us are trying to create.

Dr. Glatter: It’s a chilling verdict in so many ways. I’m right on the same page with you, having worked for so long in the emergency department and seeing nurses that are overtaxed, overburdened, but also on patient floors. This goes to an ICU-type environment where this woman was having a nonemergent head scan and required some sedation.

The question I want to get to is how the system allowed the nurse to dispense this medication —though she was distracted, she’ll admit that. Jane, I want to get to you on this. How can we avoid this? What are the system checks that can be done in some fashion to make this safer and to avoid this tragic error?

Dr. Barnsteiner: First of all, I would say that you do not put in a major change, as they were doing with their EPIC system, as a big bank where you do the change through the entire organization. You do it in one area where you get the whole system smoothed out and all the errors taken care of so that you’re not having a problem like they had through their entire organization, which required overrides multiple times a day.

One of the things that’s been recommended is that these systems, like the Pyxis system, require the first five letters of a medication to be entered into the system so that when you have multiple medications where the first two letters are the same, the chances of pulling out the wrong medication are much smaller.

There’s a question of whether this medication, vecuronium, should have even been in this machine. You can have high-alert medications like this in baggies that have written on the front of the bag, “This is a high-alert medication. It requires two independent double checks.” These are all the things that will help alert the fatigued or distracted nurse or physician and will make things safer. There are many things that can be put into place.

Dr. Glatter: It’s almost like a hard stop. This is a different class of medication. Even if the nurse had a lapse and didn’t realize that, there should have been a hard stop asking whether you want this class. A sedative and a paralytic are two very different medications.

I’m not trying to assign any blame here. I’m just trying to look at mechanics of what happened and how we can put in place methods to avoid these types of errors where a system clearly is overtaxed and overburdened. Is it an artificial intelligence alert? Is it a pharmacy alert that goes out? Is it a Vocera message that gets triggered? It’s something to stop the nurse from doing something where they know better.

She’s used Versed before, apparently, and knows it’s a liquid and doesn’t have to be reconstituted. In my mind, as a practicing doctor for a long time, I see this and I see how it can happen. There are ways I think we can address it. Megan, I want to bring you into this and get your viewpoint.

Dr. Ranney: We’re working in an environment right now — and obviously, this happened pre-COVID — where medicines are constantly in short supply and we’re constantly dealing with substitutions of one for another. This has worsened during COVID, but it existed in the pre-COVID era as well. We’d have time periods where, like today, we’re out of D50 and we have to use D10, or we have a different formulation of a common antibiotic.

I could totally imagine that this nurse had been exposed to multiple medication substitution and so they were rushing; they thought, well, they just put one thing in instead of another and didn’t make that kind of cognitive connection.

What we know so well from our studies of human factors, engineering, and the way that systems work is that when someone is cognitively overloaded and constantly having to think outside the box and make decisions, particularly when they’re exposed to a new system for ordering medicine, there’s only so much that the brain can do at a time. This person was set up for this type of error.

Again, not to say that they didn’t do something wrong. That’s why we have a civil system. That’s why we have licensing. That’s why we have malpractice. To call this a criminal error when they were working within a system that had all these other problems where they were constantly having to make do for system failures, it’s almost inevitable that at some point something really horrible happened.

I’m sorry that it was this nurse, and how horrible for the patient and the family. I’m not excusing that. You can totally imagine, as a practicing physician, nurse, or anyone else in the healthcare system, how this happened.

Dr. Barnsteiner: The other part of it was that they did not have in place, at this time, the barcoding system in this particular patient area. What nurses are used to doing is when they have to pull a medication, they’re using the barcoding system to coordinate with what’s in the electronic health record, with the medication, and with the person’s ID band.

Those are all well-known safety checks that obviously were used to being used by this nurse in the critical care unit but that weren’t available in this MRI area. That is something that absolutely is a system failure. Those kinds of safety systems have to be available at any place in a health system where medications are being delivered.

Dr. Glatter: I think that’s an important point. Here, we have a technology that can supersede the ability of a human to make a mistake, and to have that in place is very critical. I want to go back to the idea of medical malpractice vs homicide charges.

Megan, you made a point of this. This nurse is now an example of someone who went to trial and was convicted, and it could have a chilling effect on healthcare providers. Pre-COVID, post-COVID, it is just chilling. It makes people want to leave the field. It causes PTSD. The psychiatric downstream effects of such an error are just immense.

I don’t know how the district attorney went for criminal charges here. I’m not an attorney and we don’t have a legal expert with us. For this to have happened is just setting precedent that it’s okay to have the effect of making so many people leave the field.

Dr. Ranney: I’m not a lawyer, but I’ve certainly been on the front lines, not only for the past 2 years during COVID but for almost 20 years prior to that. I will say that these types of errors are never-events that sit with our colleagues and friends for their entire career. No one goes into medicine intending to hurt someone. The system fails us and fails the patient.

There are certainly examples of intentional harm, and those people deserve to be prosecuted. This type of thing where a system let them down, again, should require an inquiry of the system. Don’t punish the individuals to the point of putting them in jail.

I think about my last few months working in the emergency department and what my nurses, in particular, have said to me. They worry that they’re going to lose their license and their ability to practice because of the horrific circumstances that we’ve been working in — the understaffing, the lack of access to standard medications, the long wait times, and on and on. They’re not able to take care of patients the way that they’ve been taught to do.

They’re worried already about the downstream effects on their sense of self, as well as on their ability to maintain their livelihood. When you put something like this on top of it, where again, an unintentional error that was potentiated by a somewhat broken system or by a series of Swiss cheese holes that just happened to line up, what message does that send to my nursing colleagues who have stayed on the front lines and who know that they have not been able to provide the standard of care that they’re used to?

Dr. Barnsteiner: On Friday, I did a program on fair and just culture with three health systems and a university school of nursing. Already, some of the faculty reported that students are talking about transferring to another major outside of the School of Nursing because of their worry about this particular guilty verdict.

The other thing is that we already have a tremendous shortage of nurses. We’ve seen many people leave the profession or retire in the past couple of years, and this is only going to compound it further. It is a sobering message that the public can’t afford to have, actually, because this will impact the quality of care and the safety of care that can be delivered to people and families as a result of not having sufficient numbers of professionals to deliver care.

Dr. Glatter: That’s such an important point. In any high-reliability organization, a culture of safety is key. There are tenets we try to adhere to. When we have people leaving the field after seeing a case like this, it’s chilling. We have to re-educate the public and we need to have a realignment of how errors are handled.

This is just the beginning. Her sentencing is going to be in about a month, and we’ll see what happens on reckless homicide charges and neglect. I think there’s going to be a follow-up to this and we’re going to need to discuss this more.

I just wanted to get a couple of takeaways for our audience to just really sear in the brain what we can learn from such an event.

Dr. Ranney: The big takeaway, to me, is the importance of us both continuing to use our voices and working across professional boundaries to help to create this culture of safety, one in which we all feel safe and supported in advocating for systems that work for us. We cannot ask nurses, respiratory technicians, radiology technicians, physicians, or anyone else within the healthcare system to work unsupported, and we have to recognize the degree to which we are all interdependent. My biggest takeaway is for us to use our voices together.

Dr. Barnsteiner: The takeaway that I would have from this, and what I’m working with a number of health systems on, is to have the chair of the board, the CEO of the hospital, the chief medical officer, and the chief nursing officer together promulgate a statement that is sent out to all employees to discuss this verdict and to say what they’re doing to promote a high-reliability organization and a fair and just culture. They should also ask for open conversation and for employees to let the top leadership know any concerns that they have about vulnerabilities in the system. It’s extremely important right now with this verdict that the leaders in healthcare settings, as well as in education settings, let people know what they’ll be doing to protect their employees.

Dr. Glatter: Jane and Megan, I want to thank you so much for such an important discussion that was very informative. I think there’s going to be a follow-up to this that’ll be very, very important. Thanks again.


Robert D. Glatter, MD, is assistant professor of emergency medicine at Lenox Hill Hospital in New York City and at Zucker School of Medicine at Hofstra/Northwell in Hempstead, New York. He is an editorial advisor and hosts the Hot Topics in EM series on Medscape. He is also a medical contributor for Forbes. Dr. Glatter has disclosed no relevant financial relationships.

Megan Ranney, MD, MPH, is professor of emergency medicine and the academic dean at Brown University School of Public Health in Providence, Rhode Island. She is the director and founder of the Brown Emergency Digital Health Innovation (eDHI) program. She is also chief research officer for the American Foundation for Firearm Injury Reduction in Medicine, the country’s only nonprofit committed to reducing firearm injury through the public health approach, and a founding partner of GetUsPPE.org, dedicated to matching donors to health systems in need of protective equipment. Dr. Ranney has disclosed the following relevant financial relationships: Serve(d) as a speaker or a member of a speakers bureau for: Medscape; Merck.

Jane Barnsteiner, PhD, RN, is an emeritus professor at the University of Pennsylvania School of Nursing and an expert on patient safety, quality improvement, and system modeling. In addition to her teaching responsibilities, she was director of translational research at the Hospital of the University of Pennsylvania. Jane was one of the developers of the Quality and Safety in Education for Nurses (QSEN) initiative and is co-editor of Quality and Safety in Nursing: A Competency Based Approach to Improving Outcomes, published by Wiley. She has disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.