Transcript Video Guidelines, Protocols, Implementation and PersonalisationProf. Benjamin Abella < Back to Boundaries of Temperature Session 2: The Patient Guidlines, Protocols, Implementation and Personalisation Presented by Professor Benjamin Abella So it's a pleasure for me to welcome you to the second session and especially I welcome Professor Benjamin Abella. He's the head at the Department of Emergency Medicine and the Department of Medicine division of pulmonary allergy and Critical Care. And he is the Clinical Research director at the Center for Resuscitation Center at the University of Pennsylvania School of Medicine. And important to mention that he was involved in the latest revision of the CpR guidelines of the american Heart association. So please talk to Baylor. Right, well, it's good to be with all of you. Hopefully sound everyone can hear me okay? Good, great. Um so yes, thank you for the nice introduction as stated, I'm at the University of pennsylvania where I lead a research team involved in cardiac arrest and post cardiac arrest research. The charge I've been given today to talk to you. Uh Today's lecture, I'll come back tomorrow as well is to talk about the guidelines, how they work, how they have involved post cardiac arrest care because as all of you know, one of the major roles we believe of targeted temperature management. Of course, there's some current controversy about the gold temperature. But that's for a later moment however, you interpret it. T. T. M. Is an important part of post arrest care and therefore it's important for us to think about how this is broadcast through the various guidelines processes that exist around the world and then also how those guidelines are implemented. So that's what we'll try to do in today's talk if you want to get in touch with me or follow up thoughts here are some twitter handles. I'm also happy to speak by email. So first, a little bit on the history of resuscitation care because I think it's important understand the context that uh this notion of resuscitation guidelines, this notion of post arrest care, it's actually more recent than I think many of us appreciate after all, CPR was only invented in the 19 fifties. And I show you here some photographs from johns Hopkins where chest compressions were essentially arguably invented in the pig laboratory. And then the right picture shows Peter Safir demonstrating what we consider modern mouth to mouth breathing, bag valve mask, breathing in some fashion. The notion of breathing life into people has been around for a lot longer. But the modern version of bag valve mask, that really was the foundation of modern CPR really was invented in 1959 and published 1960. And then you see here in the last uh image very rapidly. This concept of teaching CPR and teaching resuscitation skills spread around the world. So, this is one of the very early examples of a course on closed chest cardiac massage and rescue breathing. So, it's not that old of a concept Now, the notion of targeted temperature management also has, in a sense, been around for a long time, but in a sense, in its modern iteration for post cardiac risk care has been relatively recent. So in the fifties and sixties, a large number of animal studies were done to show that targeted temperature management at that time, the term was therapeutic hypothermia, that cooling animals would improve outcomes after cardiac arrest. And this is an enormous literature. One could almost do a whole day conference just reviewing all of this work. But I'll just tell you that one of the most important bottom lines from the animal studies have been that there's a mechanistic uh understanding of how T. T. M. Works because you can look at brain tissue, inflammatory markers, heart tissue and also a dose effect, which is a very powerful piece of evidence. So in almost all of the animal models, the deeper you cool, the longer you cool, the better the outcome. So it's a very convincing case that this need to move to the clinical arena and this is sort of what it looks like in schematic form for animals or humans for that matter. This notion would be that you would cool the animal or human to 33 keep them cold for a period of time and current understanding 24 hours, although there's some variations on that as well and then re warming to norma ther mia. And this was studied in the lab and then in a series of observational clinical studies as well that also showed a benefit and this basically stimulated the field to do randomized trials and here I show you the summary of all of the randomized trials, essentially the big ones anyway, published to date on post cardiac arrest targeted temperature management. So there are three studies to the foundational studies uh from 2002, and then a more recent one out of France in 2019. And and we don't have time to go into all these in great detail. Um and then on the middle column to multi center trials that you all probably heard of the T. T. M. One and two trials. And on the left column, those three trials were all randomized trials of cooling to 33 Celsius as a target for post arrest care. And they all showed a benefit. So all three of those trials showed improved survival and neurologic outcomes when patients were cooled to 33 in the middle column are the T. T. M. One and two trials that were neutral. So in the first one, so the column headings are little not purely accurate. In the first study, the T. T. M. One study, they showed that 33 36 yielded equivalent outcomes. So it wasn't proven that team didn't work. Indeed did the opposite. It was basically a dozing trial and they found that if you did T T M at 36 you could have the same outcomes. Now, the bottom one, they found that therapeutic norma ther mia that if you use T Tm technology to avoid fever very carefully, it also may be equivalent to 33. So, um and then as first studies that show that 33 is worse. There are none. There are no studies published that showed that 33 is assisting with the worst survival neurologic. So in the overall score board of Studies three R. C. T. S showing a benefit to our neutral and non showing a harm. Now this is a very sloppy and unfair way of looking at studies because of course there's issues of study validity and sample size. But in the big picture it's important to note some studies show benefit and no studies show harm. Now that's important because that leads us to the guidelines discussion of where they came from. And first I'd like to point out that before in two up to 2005 um the guidelines had this notion of the chain of survival and you've all learned this in various courses BLS courses and the like with four links in the chain. So they end with a CLS. Well after the foundational trials of 2002 the guidelines started to incorporate post arrest care. So again, the theme here, this is relatively recent. So only in 2005 did the notion of post arrest care. And by the way, not just T. T. M. But all the other critical care interventions in post arrest care only in 2005 did that included as 1/5 link in the chain. Okay so it's all relatively recent in the guidelines. And how are these guidelines developed? Well, a little bit of the nuts and bolts for those who don't know. There's an international body called the International liaison committee on resuscitation, bit of a mouthful. And this is a group that is charged with reviewing the evidence as it comes out. They meet periodically and they come up with something called the consensus on science, which is a document that doesn't tell organizations or entities what to do at a practical level. But they give essentially they grade the evidence and they give overarching statements that then get interpreted by individual resuscitation councils, organizations in different countries. Bit of a bit of nuts and bolts there. But and I show you here just the examples from a variety of regions, certainly many of you are from europe and you know, of the european resuscitation council in the U. S. It's the american heart association that largely drives this. So L. Cores work, their work output goes to these organizations and then each of these organizations in their respective regions or countries develops actual courses and guideline books. And this is important to know because although the science basis is the same or the scientific interpretation is the same. There are differences between countries and regions and how it's interpreted and how it's promulgated in those countries. So if you look at the european guidelines with H. A guidelines, there are some subtle differences and and we'll get to that in a little bit as well, a little bit more about quartz is large group. You certainly were never intended to see the names on that slide. I only show you that say there's a lot of people involved the two heads. If you ever want to seek them out for complaints, suggestions, concerns whatever. I'm sure they will appreciate me naming them here. Um, bob Newmar and Gavin Perkins. Gavin's in Birmingham, England, United Kingdom and bob new mars at University of michigan. Um and longtime resuscitation scientists who have been involved in this area. So the guidelines, so the guidelines in 2005 1st included T. T. M. as a recommendation. Well, it got modified over time and I show you here both 2015, And again, you don't have to read the words. I will tell you the key points here. Um, in 2015, the recommendations were broadened. So it used to be. Initially, the recommendation was to cool patients after cardiac arrest or use T. T. M. If you like, between 32 34 or 33 Celsius. But they gave a range now that changed in 2015 to a broader range from uh 2032 to 36. And that's what's persisted to 2020. Now, a very important point about this because it's often misinterpreted, this does not mean you can allow someone to wander between 32 36 after all. Many of you are in critical care. A foundational principle of critical care is we don't like a lot of variables. We don't like a lot of changes in critical patients. So you pick a temperature and stick with it. That was the intention. But you can pick 33 you can pick 36 you can pick 32 if you like. It's all evidence based but that the range was the new recommendation and that's because that T. T. M. One trial showed that 33 36 were equivalent at least in those patients. Now. Tomorrow we're going to get into a little bit more depth on these and and myself tagging with Willie Barringer who was here to Dominican areas, we are going to try to make the case to you that there are some limitations to the arguments made by T. T. M. One or two. We will try to help interpret that for you. But that's for tomorrow. If you if you come back for that now the E. R. C. Has come out with some changes based on T. T. M. Two but the A. J. Has not. And that's one of these important differences. I'm going to get to that shortly. So in 2021 the R. C. Had a post process taking your guideline that did still include T. T. M. 2 32 to 36. But then after the publication of the T. T. M. To trial which just came out this last year um for the I'll give 30 sec on that for those who aren't familiar. This was a trial let out of Sweden a multi center trial. Looking at 33 versus therapeutic norma ther mia a little bit subtle how they defined it but suffice it to say aggressive fever avoidance and they found equivalent outcomes. But as I say we'll talk more tomorrow about it based on that publication that showed equivalent guidelines outcomes. The E. R. C. Then went to recommend that we just do normal hermia. So it was a pretty aggressive change actually. And there are those and I'll be the first to admit I don't I don't sit totally comfortable with this with this big of a change. They did leave the door open and then the texture they said well there me there was clearly a lot of discussion about this change and some of the people in the room I felt you know 32 to 36 still has a lot of evidence behind it. Maybe there are subsets of patients who deserve that. But that sort of barely made it into the document honestly. And and the overarching recommendation was aggressive fever avoidance. So T. T. M. Technology may still be required but just to avoid fever. This is without not without controversy. As I said because some of us still feel that cooling has a role at least for some patients. Well, so those are the guidelines. So now, you know what they are. The other question is how are they implemented and what does anyone do with them? Um And this is one uh study that essentially looked at how guidelines get implemented. And um this was looking at a large group of hospitals, the United States and again not to show you the specific data, but just to make the overarching point um that when you look at the percentages of hospitals that are actually implementing T. T. M. It's highly variable, it's all over the place. So just because a guideline exists, doesn't mean people do it or hospitals do it. And we see this all across medicine of course, because there's this issue of implementation guide guidelines need to be taught, they need to be interpreted, There needs to be mental bandwidth of providers to listen and incorporate them into practice. So, I think this is a challenge for the guidelines groups because they'd like to think we wrote a guideline, we check a box the world is solved, but that is hardly the case. And indeed this I think is a very striking example of what some of the clinical studies can do uh in actual clinical care where they even get ahead of the guidelines. So this was a publication of the United States that looked at the use of T. T. M temporally over time after the T. T. M. One study was published. So the T. T. M. One study showed that 33 36 were equivalent. It turns out it was massively misinterpreted across the world. And in the United States in particular I think to suggest that T. T. M. Doesn't work. But in fact the authors never claimed that they were comparing two different T tm goals. So it would have been fair for hospitals to switch their goal to 36 that reasonable people could disagree but that at least would be based on some science. Indeed what happened? And this study shows it that people just stopped using T tm people said well 36 is close to body temperature it's equivalent. So never mind. And there were there's a big drop in the use of any T. T. M. And those of you who know about neuro critical care know that after cardiac arrest many patients get neurogenesis fevers and these fevers are very bad. They're not beneficial fevers. And and so we subjected I think many more patients to potential harm by not doing anything with the temperature. So again these guidelines are limited both in that they have to be timely and even when they are timely they're often not implemented and we think it's bad in the United States. Here's a publication out of china and this is from 2017. And they basically found that less than 10% of physicians in the I. C. U. S. And China in the survey and they did in a number of provinces in China had used t tm at all less than 10% of physicians. Um and when asked why they said a variety of things like it's uh the guidelines aren't so clear or it's too complicated to do. In other words, all the typical answers that one gives when one is caught flat footed and that doesn't really have a good answer. Oh well this reason or that reason but fundamentally the point these authors made were china, we have a problem, we're not doing a therapy that's so important in patient care. So how does one address the sort of gap in implementation? It's a big problem all across medicine and it requires things like this. This is a course where people come and learn but this is a course more about the science and big picture. What really I think needs to happen more worldwide is implementation courses, practical courses. But who is the time, the resources, the money for that. Right? So it's a challenge. Well it's something that we wanted to address at penn locally because we recognize there's this gap in implementation, there's all these trials that are being misinterpreted or partially interpreted correctly. Um but they exist. The science does exist and there's all these commercial devices made by many companies that allow for TPM implementation but yet on the other hand, as we worked with hospitals in the United States, we saw, wow, there's so much confusion, People aren't really aware of the guidelines, aren't aware of the studies. So we wanted to bridge that gap. And of course, Covid has made everything worse as you all know. Um Covid has stolen a lot of our bandwidth for intellectual growth for refreshers for implementation time because we've been dealing with a major crisis. So if anything, post arrest care knowledge and implementation has deteriorated over the last few years. Depressing but true. So one of the things that we realized as we worked with many hospitals in United States to bridge this gap and we've run a series of courses there is that we need champions. It's too much to expect every nursery physician, every hospital to really be ready to do something which is in most hospitals, done maybe once a week, maybe a few times a month, maybe in really busy hospitals a few times a week, but not every day. And what is this why is this necessary? It's in part because the care of cardiac arrest spans the entire hospital. So out of hospital cardiac arrest, O. H C. A. These patients come to the er some of them go to the Cath Lab, some then they go to the I C. U. Many different teams, many different specialties are involved. Eventually go to the wards and then home this hits medicine globally. I speak globally here, all of us suffer. This this hits medicine at its weak point across silos. If you want to change something in the critical care unit, that's a lot easier than changing care that spans all the way from E. M. S. To the I. C. U. To the wards. So that's why hospitals need coordinators or champions who can oversee these processes. Um because what we found is many hospitals. They have a different protocol in the E. D. In the I. C. U. And you can only imagine the confusion and trouble that that can create. And so we've we've sort of realized there's a few different models and I think each of these might work in different institutions. But I would argue it's very important that any hospital have one of these models or something like it. So in one strategy you could have a physician nurse team. I think that's actually often very helpful to have someone representing the medical physician side and the nursing side to serve as leaders of a. T. T. M. Protocol or post arrest care protocol. Now a little bit more complicated perhaps, but done in some hospitals is to have each key unit in the Cath lab, the medical iCU, the coronary ICU to have their own champion. And of course that's a larger group. It's more complicated but but that distributed approach may work better say in much larger hospitals. Um And then a third strategy that we've seen in some US hospitals is to exterior rise it with a tele medical approach where the Champion might be some outside of the system. Who could sort of beam in the advantage there of course is it's efficient. And then also it can be sort of for point of care. Champion work as well because they can be men anytime, anywhere, at least in theory. And so what would a Champion team do? Well, they keep the protocol, Someone has to know what the current protocol is. Because after all the science keeps changing. Many hospitals keep updating their protocols. And I'm sure you've all seen this where when a patient comes two in the morning, people use the protocol from five years ago because that was what was in the binder on the shelf and they aren't aware that we changed a few months back. But then also to answer questions, I see a lot of misinterpretation of of how to do post arrest care and T. T. M. So Champions would sort of be the keeper of the frequently asked questions and their answers. Um and then they would do quality assurance to look at the data so that they can keep the quality of care assured. And there's a variety of things in the United States for data collection. I'm sure it's different in europe. But collecting cardiac arrest data collecting outcomes is so crucial, especially in this current era where norma author mia maybe an option. My prediction is many hospitals switching to normal thermally protocols will see worsened outcomes. And there's science to back up that prediction. But we won't know until we collect data because if we find survival worsens, that might be important information to know. Uh for thinking about the future. Now people have looked at implementation strategies for post rest care to try to wrestle this problem. And this is an example of such a publication. This is out of Toronto where they actually did a stepped wedge trial of implementation strategies to get hospitals to do a better job. And indeed they did. They especially were able to improve your uh prognostication. A major problem in post cardiac arrest care is early withdrawal premature withdrawal of care. And they were able to impact that through their strategy. So that was an important finding that implementation science does work. We did look at this ourselves with, we run an intensive workshop in the U. S. For hospitals and implementation of post arrest care. And just to show you some data here. The top line is that we found that after the courses when you intensively trained people guess what they do a better job. Uh And and more people got appropriate care and there was more self efficacy which is important, providers just felt more comfortable understanding how to take the science and put it to the bedside. Um And and so these protocols include a lot more than T. T. M. And I show you here an example of many of the things that go into a complicated postgres care protocol. Far too much to cover in 20 minutes, but know that it's T. T. M. In combination with a number of other modalities. And um with that these are some members of my team. And I just show you this picture to show you a cardiac arrest survivor there on the left. The tall guy um when we have survivors to do well, we bring them to a course as we bring them to events to tell their stories. It's very powerful and indeed a little later today, you're gonna hear from a cardiac arrest survivor and I think we'll all find their story very inspirational. Thank you very much. Created by
