All right. Good afternoon, slash late morning. This is about two dozen more people than I was expecting, so thank you for coming. I've been here for a week. I taught a pre-course, so my voice may or may not hold out. We'll see. We're going to talk for about 20 minutes about the same topic through a little bit of a different lens, and I'm going to try to introduce some concepts that I hope will be helpful to you when you're thinking about this. I don't have any relevant financial interests to disclose. I don't think we're going to talk about anything off-label. A couple of considerations. Although I spend the majority of my clinical time doing critical care, I still practice in the operating room and I'm an anesthesiologist, so I'm going to offer some perspectives through the lens of a practicing anesthesiologist, so I have on my anesthesia hat. We're going to talk about some regulatory stuff, which, although not terribly exciting, is important in this space because it presents a risk point for both your practices and, you know, potentially you personally, and that discussion is very U.S.-centric, so if there's anyone here not from the U.S., that discussion will be less pertinent. And overall, I'm going to kind of focus on adults, but a lot of these considerations, I think, are relevant to pediatric environments. Any pediatric folks in the audience? Okay, fantastic. I see some suitcases in the audience, okay. So what are we going to talk about? I'm going to contrast dedicated procedural settings, by which I mean operating rooms, procedure suites, endoscopy. We're going to compare and contrast those to the intensive care unit because there are similarities, but there are also important differences. We're going to talk about the regulatory landscape. I'm going to highlight just a very narrow slice of the relevant peer-reviewed literature. And I'd like to just make some concessions at this point. So, you know, like we just talked about, bedside procedures are sometimes absolutely necessary. There's no alternative. You know, when you're in the CVICU and you've got tamponade after your cabbage, you know, you need to get back into the chest. You know, when you've got awful abdominal compartment syndrome and you can't go down to the operating room, like, you need to fix that at the bedside. And there's very compelling literature, and I think we all know from our, you know, day-to-day practice that doing bedside procedures is just sometimes, you know, equally efficacious and easier and faster and less costly. And we all know that moving critically ill patients around, you know, is not without its risks. So, you know, I just want to, again, although I'm arguing the con, sometimes we got to do it. So I'm going to maybe raise the white flag and just say that, you know, really, bedside procedures, we can often do them safely and effectively. And with that, you know, thank you. I'm kidding. We're going to carry on. So let's talk first about comparing and contrasting operating rooms, dedicated procedural environments in the ICU. And this is really just kind of a thought exercise for you to think about your individual practices, your individual intensive care units, and exploring what latent risks there might be to doing bedside procedures that you might not appreciate on the surface. So let's talk about dedicated procedural settings. So just a quick show of hands. I'm sure we have some surgeons in there. Who works, at least part of the time, like in an operating room or in a procedure room? Okay. Some folks in the audience, not everybody. So, you know, if you haven't spent a lot of time in these settings before, you know, recognizing that this is a multidisciplinary, multi-professional conference, I mean, they are really unique. They are really unique environments. I mean, they are built and resourced to do a thing and to do it extremely well over and over again, day after day, to produce reliable and safe outcomes for patients. So, you know, we think about operating rooms as a, you know, as a place, as a physical place where people go and they've got materials and surgical supplies and anesthesia stuff. But it's not just about that. You know, there are people and teams in those places who are highly practiced. Additionally, most dedicated procedural environments are engineered to benefit from adjacencies, right? If you've got a problem in operating room one, over in operating room two are people and equipment who can accomplish the exact same stuff that you can do over in operating room one. The blood bank is usually close by. There's like a satellite pharmacy. There's a recovery room. If something goes wrong, people can rush from over. So there's a lot of adjacencies that are engineered and efficiencies that are engineered into these environments that are really remarkable. And a lot of times we take them for granted when we work in these places every day. And the net result of all of this, the infrastructure, the teams, the efficiencies, the adjacencies, is that these procedural settings are really engineered to be highly reliable, to get procedures done safely every time, day after day, case after case. And for those of us even who work there every day, we take it for granted. Okay, so intensive care settings are interesting, right? You know, ICUs also have big multidisciplinary teams who are very good at doing what they do every day, you know, but they're designed differently, right? They're not purpose built to get procedures done. You know, typically they're a little bit more cramped. You've got a lot of materials in your ICU, but I mean, how many types of suture do you have? Do you have surgical supplies up in your ICU? You know, and what about your human resources in the intensive care unit? You know, I would guess that now, and especially over the past few years, your human resources in the ICU are probably more stretched than they've ever been. And, you know, when you're working in the intensive care unit, a lot of times there are competing demands on you and on your team members that you don't face when you're in dedicated procedural settings. You know, like me as an anesthesiologist, when I'm wearing that hat and I have to take care of more than, I'll say, you know, three patients in the operating room, you know, that's a stressful day, you know, versus up in the intensive care unit, you know, that calculus looks a lot different because of the, you know, the resources and the time and attention that's required to get someone through a procedure safely. It's a lot different than taking care of somebody in the ICU, you know, and typically in intensive care units, as we'll explore in a little bit, we often don't prioritize redundancy. Like we were just discussing, an element of safely doing bedside procedures is having some sort of timely response system. So the question I want you to think about in the back of your mind is, you know, recognizing that we all do procedures at the bedside in the ICU, of course we do, you know, is your intensive care unit really engineered and staffed and purpose-built to deliver high reliability procedural care for your patients? Just think about it. Now we're going to talk about rescue, okay? Can you reliably rescue when things go wrong? So let's talk about some latent risks, and again, these are, you know, purely hypothetical questions, but, you know, what would happen if your unit, if you're doing a procedure at the bedside and you've got a secure airway, and then like all good secure airways, it becomes unsecure, it falls out. What happens if your proceduralist encounters really serious bleeding and you need surgical equipment that you don't usually keep? You need hemostatic adjuncts that you don't usually keep, or you need blood that you don't usually keep, or you have to start massively transfusing, maybe your unit's used to that, maybe it's not. What happens if the patient down the hall has an emergency? What if patients, two patients down the hall has an emergency? What if the train recognition shows in when you're trying to get a procedure done at the bedside? What if you thought the Belmont was working, but you go to plug in the Belmont and, oh, it's exploded? You know, like, I know it sounds silly, but, you know, we encounter these things in the intensive care unit while doing The difference is that in the operating room, there is a plan A, B, C, D, E, F, and G, I can tell you, for each one of these different contingencies. And even if you don't have an explicit plan, because they're engineered to be high reliability, there is implicit backup in those places that oftentimes does not exist in intensive care units. So food for thought. And I think that this is important because, you know, and again, I won't ask for a show of hands, but, you know, many of us when we think about doing procedures at the bedside in the intensive care unit, depending on what it is and the circumstances and that sort of thing, your blood pressure might go up, your heart rate might go up a little bit, you might take a deep breath to steel yourself for what's to come. And that can be a sign of inadequate psychological safety. And, you know, I think in this day and age where we're dealing with a fractured critical care workforce, you know, we've got to think about, you know, how to engineer a system that's You know, we've got to think about, you know, how to engineer not just patient safety and high reliability, you know, kind of infrastructure around procedures in the ICU. You also have to think about how to engineer psychological safety. And if you think about your kind of journey here along the, oh no, yes, there we go. If you think about your kind of journey along the quality improvement process to the boundary where we encounter psychological safety, you know, you've got to think about these issues that we're talking about proactively in your ICU. You know, you're in your ICU doing a big procedure at the bedside, maybe a once in a blue moon thing, you know, then I think that's a lot different than ICUs where you're doing bedside procedures routinely. In both of those environments, you know, clearly this is important to think about. But I think especially if you're working in an ICU where you do a lot of bedside procedures, you need to do everything possible to get to this point of psychological safety so that team members don't feel intimidated by trying to undertake this. And again, just a rhetorical question. Think about if this describes your intensive care unit. And are you really trying to wire your ICU to be high reliability in this fashion when you're doing bedside procedures? So what are some characteristics of a high reliability operation? I'm going to put them up here. So, you know, if in thinking about this conceptually, you think you might be below that threshold for psychological safety, these are some things, some kind of process improvement things you could think about to try to get to that point. Again, just food for thought. So again, when we think about trying to bridge this potential gap in your individual ICU, you know, it's important to not only be reactive, but to think about your environment, the way that it's engineered, the way that it's structured, the types of procedures that you're doing, how you typically do them. Think about ways that things can go wrong proactively and engineer fail safes and safety checks into those processes, again, to increase safety for patients, increase psychological safety for your team. And I think that's all I have to say about that. So that's the end of the first part. Now, if that seemed boring, don't tell me. Please don't. But if that seemed boring, we're going to talk about regulation now. And I'm going to try to move through it efficiently. But I think that some of this may be new to some of you. So I'm going to talk about it. So we're going to talk about procedural sedation. So obviously, one option when you're doing bedside procedures in the ICU is just to hit the staples, oh, sorry, the large office chain easy button, boop, and call the anesthesiologist up to come and do the procedure. But I would hazard to guess that if it was that easy, you might be doing some procedures down in the operating room, right? One of the things that we talked about that drives us to do procedures at the bedside is that it's often more timely. And if I take off my anesthesiology hat for a second, one of the things that can make access to dedicated procedural environments less timely is the fact that it can take us a little bit of time to get our proverbial shit together. So a lot of times when you're doing procedures up in the unit, you may be doing them without the help of an anesthesiologist. There's not necessarily anything wrong about that. But when you're operating in that framework, you're operating under a non-anesthesia, well, kind of non-anesthesia procedural sedation framework. And unfortunately, the regulatory landscape around this in the U.S. is extremely complicated and a little bit weird. And as we're going to explore, the procedural landscape or the regulatory landscape around procedural sedation looks a lot different than our contemporary multidisciplinary, you know, multi-specialty practice of critical care. So you may be thinking to yourself, so what? We do procedure, we do sedation all the time in the ICU. Half the patients are more sedated, you know. And I will, of course, recognize that like we as critical care clinicians are very good at using these drugs and managing sedation. But like I said, the regulatory landscape is complicated. And generally speaking, the definition of procedural sedation, right, is when you're doing sedation to facilitate a diagnostic or therapeutic procedure. So there's a little bit of a weird regulatory gray zone. So when you've got like, you know, Ms. Jones in bed one and she has ARDS and she's, you know, proned and deeply sedated and paralyzed, that's not procedural sedation. But when you flip Ms. Jones back over because you're going to do a central line and maybe you deepen the sedation, is that procedural sedation? Some would argue that it is because you're doing it to facilitate a diagnostic or a therapeutic procedure. It's a gray zone. And your institution, your organization, may or may not have defined what counts as procedural sedation in the ICU. I would encourage you to find out for reasons that we're gonna talk about. So, again, I'm putting on my anesthesiology hat. Bear with me. So the American Society of Anesthesiologists has defined the continuum of procedural sedation as follows. It makes sense, right? You give a little bit, the patient feels less anxious. You give a lot, the patient's under general anesthesia. A lot of times we call stuff moderate sedation, right? Okay, so this is the definition of moderate, sometimes called conscious sedation. Purposeful response to verbal or tactile stimulation. Patient's sitting there with their eyes closed. You say, Ms. Jones, are you okay? Yeah, I feel good, thank you so much. Or you touch the chest and they wake up. You say, Ms. Jones, are you feeling okay? I'm doing good. So let's say you're gonna do a cardioversion under moderate sedation. Is that patient under moderate sedation? Would you feel comfortable shocking somebody with that level of consciousness? No. So a lot of times in the ICU, we call things moderate sedation that aren't moderate sedation, that are probably deep sedation or general anesthesia. And the interesting thing about deep sedation is that there is a whole regulatory ball of wax around deep procedural sedation that's kind of underappreciated. And in fact, it is considered by CMS, is codified in the federal law, as being equivalent to general anesthesia. So there is a lot of regulation that is put on deep procedural sedation that you may or may not be familiar with. And unfortunately, for all of you, I'm gonna tell you about it now. So deep sedation is considered functionally equivalent to general anesthesia. I'm just gonna let that sink in for a minute. Deep procedural sedation, which we probably do all the time for bedside procedures, is considered equivalent to general anesthesia from a regulatory standpoint. Okay, I've repeated that again. All right. Moderate sedation and kind of light sedation are not considered equivalent to anesthesia. That's why the regulatory landscape around moderate sedation is so different. Okay, so let's take that. And again, they say that it kind of makes sense, right? When you've got a patient who's deeply sedated, the risk of slipping into general anesthesia is high. So that's why it's considered kind of functionally equivalent from a regulatory standpoint. And I think it makes sense clinically to us, right? I mean, we've all found ourselves with a patient who's more sedated than we had intended. Okay, so there's this thing called this Code of the Federal Register. You guys familiar with this? Nobody is, right? It's like pages and pages and pages. So in the United States, we have a lot of healthcare policy that is indirectly legislated through what are called the terms of participation for the Centers of Medicaid and Medicare, right? This, by the way, is how the United States government desegregated hospitals in the United States. They said, you can stay segregated if you want to, you're just not gonna get any federal money for the healthcare that you provide. So we actually legislate a lot of healthcare in America through the guidelines for participation in CMS. And in these guidelines, they say that anesthesia, remember, anesthesia in deep sedation considered equivalent, anesthesia must be administered only by a qualified anesthesiologist, a doctor of medicine, a dentist, a CRNA, an anesthesia assistant, yada, yada, yada. Okay, what's not on here? What's not on here? APPs, nurses, not on here. Again, this is not in keeping with our modern multidisciplinary, multispecialty practice of critical care medicine. But federal regulation is here, right? So deep sedation can only be done by a physician in the United States. Fascinating, right? And CMS thought that this was confusing, so it issued some additional guidance with this lovely diagram. And here they're saying, oh yeah, you're doing deep procedural sedation, that's anesthesia, that needs to be administered by an anesthesiologist, a CRNA, or a qualified physician. Okay, why is this important? So CMS goes on to clarify, again, in the federal register, that hospitals should conform to generally accepted standards of anesthesia care when governing administration of anesthesia by these non-anesthesia physicians. So what does that mean? Like, what does that really mean? In your organization, is there a policy that allows critical care physicians to administer deep procedural sedation? Because there has to be, right? The conditions of participation in Medicare say that in order to administer deep sedation, it has to be governed by a policy, governed under the overarching sedation practice in partnership with the chief of anesthesia, right? So this, in this particular diagram here, the entirety of the anesthesia landscape, which includes both deep sedation and moderate sedation, is supposed to fall under the auspices of hospital anesthesia services. Okay, so that's my first question. So if you're a physician and you're doing deep procedural sedation, are you credentialed to do that at your hospital? Can you even request that credential at your hospital? Or will they only allow you to request moderate sedation privileges because the anesthesia department doesn't want to play ball? Okay, if so, is it governed by a relevant policy? And is there a credentialing pathway? Again, federal requirements. And does your sedation practice conform to generally accepted standards of anesthesia care? And you may be wondering, what in the hell are the generally accepted standards of anesthesia care? And again, I have on like two anesthesia hats now, so I'm gonna tell you what they are. This is what you have to do in order to do an anesthetic, right? Pre-anesthetic evaluation, post-anesthetic evaluation, assessment and documentation of environmental readiness. You have to have an individual dedicated to doing the sedation who's not doing the procedure. You can't be doing both. That's not how anesthesiologists deliver care. We don't do anesthesia and the procedure. Not a generally accepted standard of anesthesia care. You have to create a whole bunch of documentation. It's a lot. So this is what it takes to do deep procedural sedation in your ICU as far as the federal government is concerned. So if you find yourself doing deep procedural sedation in the intensive care unit, and maybe you haven't ticked all of these boxes, this can be eye-opening and distressing. And again, I fully recognize that it is a discordant with the realities of how we do this on a day-to-day basis, and the realities of multidisciplinary, multi-professional critical care. But it just kinda is what it is. And that's what I have to say, I think, about regulatory risks. Okay, let's talk about the literature real quick. And you may be wondering, ooh, this sounds a little dicey. Can the literature help us settle this safety question? So when I think about sedation, procedural sedation in the ICU, and capturing safety outcomes, I think about pediatrics. So over in the pediatric world, there is a excellent, comprehensive national registry about sedation outcomes. Intensivists delivered deep procedural sedation in the ICU from the pediatric world. And the Pediatric Sedation Resource Consortium, basically over the span of, what is this, five years here, published this very interesting study that captured about 90,000 deep procedural sedation encounters, propofol administration for bedside procedures by pediatric critical care physicians. And what did they demonstrate here? So the overall serious adverse event rate was really low. There was like one cardiac arrest that was successfully recovered, which is good, right? I mean, kids, sick, at risk for bad outcomes from sedation, 90,000, pretty good. What did they demonstrate here? So again, this was in the ICU and other areas, other procedural areas. The adverse event rate was a wee bit higher in the pediatric ICU compared to some of the other settings. Like for example, it was a little bit riskier than like radiology, but a lot less risky than say dental procedures, riskier than in the ED. So the ICU kind of falls, at least in the pediatric space in the middle of all of this kind of continuum. So you might say, okay, that's great. You guys saw a show of hands, nobody takes care of kids. So you're thinking, okay, what about adults? There's no analogous registry, none, zero, completely unstudied. So on a nationwide basis, the outcome of procedural sedation delivered by intensivists in intensive care units is unstudied in adults compared to kids. So it's a gray zone. The closest equivalent registry that we have is NACOR. Now I'm wearing three anesthesiology hats. And the bottom line about NACOR is that it doesn't capture any ICU data at all. It captures a lot of non-OR sedation outcomes. And we know from NACOR that non-OR anesthetizing locations present more patient safety risks related to the anesthetic practice, the management of sedation, than does the operating room itself. And I suspect we would see something similar come out if we had registry data for the ICU. When I think about bedside procedures or in the ICU that we do a lot, I think a lot about percutaneous dilational tracheostomy, which I'll just call it PERC-TRACH, it's less syllables. There have been a lot of studies, in fact, so many that there's a really good Cochrane meta-analysis looking at the outcomes of percutaneous trachs in the ICU. But in a recent Cochrane meta-analysis, they kind of drilled down into what I think is a very interesting question, which is what is the safety outcome when you do a PERC-TRACH in the operating room versus a PERC-TRACH in the intensive care unit? And out of this entire swath of literature, many hundreds of studies that were in the big meta-analysis, they identified two, two high-quality studies that were looking at safety outcomes in the ICU versus in the operating room. And essentially what they found, and I don't know, I didn't put an arrow here, but to make a long story short is that a safety signal in favor of percutaneous tracheostomy did not emerge when you're comparing the OR versus the ICU, this particular thing. So same team doing it in the OR versus in the intensive care unit. In the meantime, when you compare percutaneous versus open tracheostomy in the operating room, there's a safety signal that emerges in support of percutaneous tracheostomy. So what is it about intensive care units where we're losing some of this safety signal that we find in the operating room from doing the same procedure, but just in a different place? Again, a rhetorical question to think about. Okay, so you may say to yourself, okay, patients in the ICU, sedation's sounding a little dodgy. You know, are there any, when do we need to pay more attention? When do we need to call for help? When should we think about calling for help? Which patients might be at higher risk for adverse outcomes? So the European guidelines tried to summarize, I mean, what's really just a mountain of literature, and here's basically what they said. So patients with severe cardiovascular disease, so in my ICU, that's all of them. Patients with sleep apnea, in your ICU, that's probably most all of them. Patients with morbid obesity, yep, that's a lot of my patients. Patients with renal dysfunction, same thing. Elderly, ASA three and four, basically every patient in the ICU, according to the European guidelines, is at risk of bad outcomes with procedural sedation. Food for thought. Okay, so the literature in summary, not helpful. I don't think, honestly, to settle this question, we don't have a large prospective national registry equivalent to the pediatric side. And as we know, there's a lot of literature to support that doing procedures at the bedside is safe and well-tolerated, but interestingly, we have a little bit of literature in this PERC-TRAIC domain to suggest that we don't see the same safety signal emerge specifically when we compare the OR versus the ICU. And as we know, a lot of recommendations around procedural sedation are not really built to speak to the critically ill patient, right? Like in these European guidelines, those risk points are basically describing every patient that we take care of in the ICU. So I think that's what the literature has to show us. So I guess the key points I want you to take away is that obviously we do procedures at the bedside. We're gonna continue doing procedures at the bedside. Sometimes you just gotta do a procedure at the bedside. But the ICU and the operating room, they're both similar and they are different. And we don't always appreciate the impact of those two things on psychological and patient safety for us in the intensive care unit. So you've gotta work to mitigate some of those risk points. And don't forget about this wacky regulatory environment. If you're doing, if you're a physician and you're doing deep procedural sedation, make sure that you can request the ability to do that from your organization. Make sure that you have policies and procedures to support that. Make sure that you're conforming with generally accepted standards of anesthesia care. And I would also encourage people just practically to be intentional on a per patient basis. You know, obviously some procedures and some patients may confer more risk. Risk stratification as we explore it is a little bit tricky because it's not been a lot of literature about that, specifically in critically ill adults. And with that, I'll thank everybody for coming and for hanging out. Thank you.

bedside procedures

regulatory landscape

procedural sedation

patient safety

healthcare providers

anesthesia care