Hi, everyone. I'm Dr. Lori Schetter. I'm a professor of critical care medicine, neurology, and neurosurgery, and I'm a neurointensivist at the University of Pittsburgh, UPMC Healthcare System. I'm going to be speaking to you today on the impact of these revised guidelines on the critical care community. Regarding disclosures, we always have to start with those. I have no financial disclosures pertinent to this talk. I was on the writing panel for the revised guidelines. I also am on the scientific advisory committee for the Curing Coma Campaign, and I am the secretary of the Neurocritical Care Society. What are we going to be doing today? I'm going to review the impact of the revised guidelines for the determination of brain death for critical care providers. Please realize that the majority of this talk will be focused on the impact in the United States. I do not have a lot of information about international impact. I'm happy to answer questions regarding that, but this focus will be on how this impacts the providers in the United States. I will be highlighting state and institutional variability. I will discuss provider education, credentialing, and maintenance of competency, and I also review the need for standardization. While I am going to be talking about predominantly the process in the United States, we really need this to be a standardized process internationally. When I first got asked to present this talk, I thought, well, why do we need a talk on the impact of this new guideline to intensivists? Everyone knows that this is important. We're all intensivists. This is a critical piece of information that impacts all of us. Then I thought about it a little bit more and realized there were details that we really need to be aware of. The determination of death based on neurologic criteria, also known as brain death, which I will be using that term from this point forward. It's done in the ICU setting. All intensivists must be familiar with it. We have to make sure it's being done right. This is a critical examination. We cannot be wrong with this. We cannot take shortcuts. We have to make this right from the onset. If we also do that and we have standardized language and a consistent approach to the determination of brain death, we can hopefully build public trust in our ability to confidently manage this and declare death in patients with this degree of brain injury. We also have to feel confident with our words, our decision making, and what we determine in this situation. What do you as intensivists need to do? Again, I am predominantly talking about the United States. You need to review your local policy regarding brain death determination. You also need to look at that relative to your state laws. Are your state laws based on the Uniform Determination of Death Act, or are they state specific? Be aware of that. Be aware if your institution has overarching policies. Certain religious-based medical institutions do have policies that may be different than the state policies. You have to be aware of that. Do you have separate policies for pediatric and adult patients? If so, consider bringing those together into one single policy. The revised guideline attempted to do that so there would not be variations. Look closely at your policies and figure out what updates are needed. How are you going to take the time to do it? Who is going to be overseeing those updates and who is going to be managing and moving forward? We will talk about all of these in a little more detail. Regarding your state laws, in the United States, the majority of states are governed, or the policy regarding determination of death is based on the Uniform Determination of Death Act. I am not going to go through the history of that, but it is a standardized policy that is used by all the dark blue states that you see on this map. What is the majority of them? There are a few variations. The light blue states have a slight change. They have their own statement. They have enacted the UDDA, but they do have some caveats to it, basically saying that the brain death concept only applies when artificial life support is used. Since all these patients are on ventilators, then it still applies. The gray states on this map, brain death as a criteria for death is permissive, but it is not required. You do not have to determine brain death in any situation, even in a patient who is brain dead. You do not have to use that criteria. The single black designated state there is that brain death must be accompanied by a loss of spontaneous respiratory function in order to constitute death. While that is specific to that state, to Virginia, please realize that the brain death testing has to demonstrate the loss of spontaneous respiration. The apnea test is part of the examination. Again, it is in agreement with the current recommendations for brain death testing. There are a few other special circumstances that you need to be aware of, and these are highlighted here. In New York and New Jersey, the purple states, they require that hospitals accommodate objections based on any reason, whether it be religious reasons, moral reasons. They actually state that hospitals have to accommodate any concerns. The green states on this map are states that require that the brain death testing is done by somebody in a neuroscience field. Somebody has to be a neurologist or a neurosurgeon or a related field. You would have to check there whether a general intensivist meets that criteria. In Georgia, that state grants civil and criminal immunity to persons involved in the determination of death. Oklahoma actually requires that reasonable attempts be made to restore spontaneous circulation or respiratory function before pronouncing death. That seems kind of straightforward to us. It's something we would all do. Idaho actually considers or has laws that says individual communities can have some standards regarding this. It gives a little more community to local emphasis on local guidelines and local thoughts for determination of death. This is a touchy subject, but I have to talk about it. When it comes to brain death and pregnancy, there are variations across the United States. There are variations internationally. You have to be aware of those. The burgundy colored states on this map are states that absolutely invalidate, they completely invalidate a woman's advanced directives if she is pregnant. It doesn't matter how far along she is in her pregnancy. She could be just weeks into her pregnancy. Her advanced directives are completely invalidated regarding her care and her desires for care. In those states, a pregnant woman has to be maintained on support. I would suggest that people think about that carefully and practice some caution and be aware of what may happen in those states. The kind of dark pink colors, those are states that require that a fetus be considered viable for continued life-sustaining treatment. Basically, they would say that the gestational age does matter. Is the fetus of a stage in development where the fetus would be considered viable? That needs to be considered and documented in your determination of death and in your decision-making. The pink states, they have enacted the uniform rights of the terminally ill act, which means that a pregnant woman must be given life-sustaining therapy if the fetus will develop to the point of live birth. The light pink states actually are the only states that say that a woman or her proxy can direct all care. They can determine how things are managed, and they have full say in this. The gray states are essentially silent. There are no laws that govern it. It is the healthcare providers and the families' decisions regarding management. Please be aware of your own state. Realize that this may impact on your decision-making in your care and have discussions regarding the determination of brain death based on your local state laws. Okay, reviewing your local policy. There are lots of variability in brain death policies in the United States. This study actually reached out to 52 organ provider organizations and asked for policies from their local institutions. Those OPOs provided 492 different policies from U.S. hospitals, and they pertain to the criteria for determining brain death. This was conducted between 2012 and 2015. They focused on five areas. Who performs the exam? What are the prerequisites? What are the details of the clinical examination, apnea testing, and ancillary testing? There was a lot of variability. Fifty percent of the local policies didn't mention that there needed to be the absence of hypotension when testing the patients. Eighty percent, almost 80 percent, didn't talk about the absence of hypothermia. Thirty percent didn't mention who could perform the exam. We're going to go through a few of these. Who can perform the exam? You can see the variability here that people were reporting. Certain policies allowed mid-level healthcare professionals. There were other people designated. Certain places just used terms like appropriate medical providers. The kind of light gray area actually talked about an attending neurologist or neurosurgeon and primary physician. Be aware of your own policies. Maybe go back and look at those and decide who you feel at your institution should be performing brain death. What about the prerequisites for clinical testing? This gives you some examples of what was actually in the policies, how many of them talked about it, how many specifically talked about the absence of hypotension. I already mentioned that. What about confounding medical conditions? What about knowing the cause? Why did somebody come in in this situation? What caused this clinical finding, clinical scenario that we're dealing with? There was variability in talking about the absence of drugs, even paralytics. You may want to consider adding in information. Regarding specifics of examinations, there was variability in what was required as part of the examination. You can see the differences here, absences of cough reflex or the absence of spontaneous respirations was also low, but that was designated as being prior to apnea testing. See what is there in your policies regarding specific aspects of the clinical examination. What about apnea testing? There was all sorts of variability here as far as what were the final numbers. How did you do this test? What measurements were required? Did you need arterial blood gases? Did you not? What PaCO2 level above baseline was specified? Again, a lot of variability. This is something that we really should not see. The goals of this new guideline was to decrease variability, I shouldn't say new guideline, of this revised guideline. We want to decrease the variability among institutions in performing this examination. How do you do that? How do you move forward and try to revise your policy to try to approach standardization? First of all, it starts with coordination. Identify the stakeholders. Until you start working on this, you may not think of everybody. You may not realize how many people are actually involved. You need your adult and your pediatric intensivist. You need neurology representation. You need neurosurgery representation. Who else in the hospital may be impacted by this? Do you have a post-cardiac arrest service like we do here in Pittsburgh? Do you have an organ donation support team? Who is your organ procurement agency that you work with? Talking to the people that may be helping with the test process. What about radiology and interventional? They need to be aware of how you may be changing the policies and what things you're going to be requiring. Make sure you get risk management and legal involved in this. They should know your state laws and can help you sort that out. And then look at community groups. UPMC is a massive organization and we span a number of different hospitals and have different communities. We have to reach out to all of our different local communities, even though we're going to have a system-based policy, we have to make sure the local communities also agree to this and that we're addressing their concerns. So take the time to figure out who your stakeholders are. Make sure they are part of this process. Know your local resources. Who will be doing this exam? Will it all be local people? Are you going to have to rely on some remote resources? And if so, how are you going to do that? Is there any role for tele-ICU in this process? There's nothing in the guideline really talking about this in detail. What about your ancillary testing options? Since these are being changed, what is available to you at your local facility? Using remote locations. Brain death testing needs to be done accurately. It needs to be done correctly. I am not advocating for doing these examinations via telemedicine. They have to be done in person, but potentially telemedicine could be used to assist you. This was a study published in 2021 on using telemedicine examination in the neurologic diagnosis of death. 29 patients were looked at. There were 30 paired neurologic diagnosis of death examinations. What we mean by paired means that somebody was at the bedside doing the examination and a intensivist who was well experienced, well established in doing this examination was remote in through camera. We were watching the person at the bedside performing the examination and we were essentially observing every single step of the way. I will tell you that in doing this exam, the hardest part of it with current camera and telemedicine capabilities was being able to see the pupils, especially if somebody has brown eyes or dark colored eyes. That is why we actually opted and we strongly recommend using pupillometer because that is a much more objective test and the remote examiner could see the pupil response. It could be played back to them by bringing the pupillometer up close to the camera. In this exam, 97% of the patients met neurologic determination of death criteria and were pronounced dead. There was between 97-100 percent agreement across the examination elements and 97 percent agreement on the overall diagnosis of brain death. What was the three percent? Where were the problems? I already mentioned the pupils, that that was a difficult area to sort out at times. We actually modified by using the pupilometer. The other thing was some of the spontaneous movements of death you can see. Those were a little more challenging to be able to determine that they were reflex movements. But this is still something you should be aware of and consider this as a way to potentially help in the examination and the determination of death. Again, you have to have though a bedside examiner. This should not be relied on from a remote examiner. It's just that a remote examiner might be able to assist talking somebody through the test and being able to provide some secondary support. Concerning performing the examination, who will be doing it? What local providers are available? Do you have neurosurgeons or neurologists available? Is this going to be dependent on the intensivist? What about pediatric versus adults? Do you have pediatric providers available to do exams for pediatric patients? This is a real stickler now. How do you establish competency? I've been doing brain death testing for 30 plus years now. I feel like I'm competent. I've done thousands of these, but we have to make sure that we standardize this. Even with my experience, I acknowledge that I need to demonstrate the same level of competency as anybody else, which means I am going to be doing training. I am going to be getting credentials to establish my competency in doing this exam. There are also things you need to consider. What about advanced practice providers? What role do they have in performing this examination? What about trainees? If you have residents or fellows at your institution, can they be part of this exam? How will they be taught? Should they be involved only as trainees? Should they be able to do the exam with supervision? Think about all of these aspects. Also be aware of the number of examinations. Realizing that pediatrics still requires two examinations. For adult patients, one examination may be sufficient, but again, we want to be accurate. There is nothing wrong with repeating this examination. You can do them really close together and use this also as an opportunity to teach others. Establishing and maintaining competency. How do we establish standards? How do we determine competency? How do you maintain your credentials? How often do you need to do this exam to make sure you know how to do it right? These are all things to consider in your local policy. Is there local proctoring? Those of us here at a hub hospital, do we proctor our colleagues? If so, how many do we have to observe to say somebody can do this right? What are the different training options? What things are available out there for people to demonstrate competency? Do you put on local workshops? Do you require online courses? Do you have your own local course that you teach? But you have to establish standards for this, have them available, include them in your policy so that people can feel confident with the training, and the experience, and the expertise of the providers performing this examination. Getting started on standardization, the American Academy of Neurology has created an interactive tool to help people. I've included the link there that you can go to and get started with this and actually start developing and building up your own standardization and look at what's available for others. The Neurocritical Care Society also is providing education opportunities for people. There's a brain death toolkit, I'm going to show that in a minute, as well as a brain death determination course. So look for resources through the American Academy of Neurology and the Neurocritical Care Society to make sure that you have appropriate training and credentialing of all providers who will be involved in the determination of brain death. Regarding the brain death toolkit, this is free of charge. You can go to the Neurocritical Care Society website, the link is there, and it has all of these things available to you that you can link, that you can read about. They have a sample brain death policy checklist, they have sample policies for hospital adaptation. So these are resources to help you learn how to do this exam, do this exam, and make sure that everybody performing the exam is appropriately trained. The brain death determination course has been revised after the guidelines have been revised. This is available for purchase. There are group rates. It is available in both English and Spanish. So be available that this is an opportunity, as well, for education. Regarding standardization, I would strongly, strongly recommend the development of checklists. This is just a copy of our local checklist. I know you can't read it, it gives you an example, but it has prerequisites on it. It has how do you assess the patient before you even do the exam. It's also good to make sure that you have team and family alignment, I'm going to talk about that, that you have a plan for how you're going to do the exam and how you're going to manage the patient afterwards. And then the checklist should have spelled out what are the examination steps. You don't want to skip any single step in this examination. Regarding team alignment, this is just an example of a checklist for a team huddle. The idea is making sure that there's good communication, that there is plans for how you're going to test the patient. How are we going to move forward? How do we make sure family is involved? Is everybody, is every team that's involved in the care of this patient aware that this testing is going to be done? So have a checklist to be prepared for any potential obstacles. After a recent experience that I've had here at UPMC, I'm also going to develop a checklist for my local OPO for what are the prerequisites to even determine brain death. So that they can look at this and know whether that is feasible in a patient that is not doing well as they are, when they begin to interact with us and interact with the providers to make sure that they have awareness of what is possible in this situation. What are challenges? What are prerequisites that are not met? So hopefully they will realize there's still steps physicians need to do, providers need to do to get a patient ready for any kind of testing. So having a huddle and having a checklist for a huddle can be helpful. Regarding communication tips among staff, respect each other, work as a team, recognize that this is hard for many people to deal with. This is a difficult process. So be aware of your discussions, where you are, what you're saying, who's around you. When you're communicating with family, listen to their unspoken needs, support them, make sure we're sharing knowledge, have a process in place. And regarding communication to family, be respectful, realize that there are a lot of things being relayed through nonverbal comments, monitor your own body language, be compassionate. This is, again, this is difficult for everybody. Make your words simple. You don't wanna talk down to people, but they're emotionally distraught right now. This is not the time to be using your four and five syllable words. Be clear, be concise, prepare the family for what lies ahead, let them know what you're going to be doing, and don't fear speaking the truth. Let them know things are not good. I usually have four steps. I think of this in four stages. My first two are often bound together when I talk to family. Things look bad, we're doing everything we can. Despite our best efforts, things have not gone well, things are getting worse. Then I tell them that I don't see any signs of brain function left. I want to find signs of life for your loved one. I want them to show me that they are still here. We are going to do an exam to look carefully, very, very carefully for signs of life. So making sure that they realize that you are on their side, you want their loved one to be able to survive. Remember, be compassionate. This is hard on them. So your goal is not necessarily, you're proving death, but you also, you're proving death by demonstrating that there are no signs of life. And then once you have declared somebody and they have met all the criteria, don't use the word life anymore. Their loved one has died. We are not keeping them on life support. We are keeping their body on machines to maintain organs and to keep the body warm while you are saying goodbye. They are no longer alive. You do not need to, as a provider, we'll talk about this a little more, just watch your words, watch your actions. Regarding clinical testing, once you, I'll go back to that now, I've already talked about once it's over, but for the clinical testing, get your equipment ready, plan ahead for potential hurdles. I assign roles. Who's going to be my timekeeper? Who's going to be watching my monitors and telling me if we're suddenly seeing PVCs or if the O2 sats are falling during the apnea exam? Who's going to be the examiner? Be thorough, be methodical. And I would strongly consider letting the family be there. Offer them that option. Let them see this. Let them see you trying to wake their loved one up so they know that you are really trying to see if there's any signs of life. They can recognize that the things you're doing would be painful. They can recognize what they would be doing in response to this. So let them see this and it may help them understand the process. All right, a few words on apnea testing. Have a protocol in place. The key thing during apnea testing is provide oxygenation. There are a variety of ways you can do that. You can put an insufflation catheter that's smaller than the ET tube down the ET tube and deliver 100% oxygen that way. This is only appropriate for adults. I take a nasopanula, I cut off those prongs. I now have two, like a Y-shaped tube. I knot off one end and the other one, I slide down the ET tube and I will set the bedside oxygen at four to six liters a minute. You can use CPAP to deliver 100% oxygen. You can use a T-piece. All of these are options, but have a process in place that you have developed with your respiratory therapist. And don't just have one, have a couple, but at least have options there and have them spelled out so people know how to do this exam right. On the pediatric side, there's a lot of recommendations for using a flow inflating resuscitation bag with a peep valve. This could also be done in adults, but I know it is strongly recommended by some of my pediatric colleagues. For apnea testing, there are options for doing this with patients who are on ECMO. Be aware of those, have that as well in your policy. All right, regarding ancillary testing, there are only four options. This has already been talked about with you. I'm not gonna reiterate this, but what if you don't have these options? I don't have good answers for you if you've relied on EEG before, but that is no longer a recommended test. It can be used in the early stages, but it should not be used as a ancillary test to declare brain death. It could only be used as the workup to see what kind of background activity you may be seeing. But your four options are angiography, radionucleotide, and transcranial dopplers. In adults, if you don't have those options, what are you going to do? Do you transfer patients? Do you consider trying to get those options? These are all things you have to problem solve in advance and address this in your policies. I'm gonna kind of wrap up here with, I already mentioned this, but once you have gone through all these steps, once you've made your determination, don't send the mixed messages. We, from that point on, are supporting organs, not life. Life is a complex thing. It has a lot of components. It's who we are as people. It's what we do. It is more than just a heart beating, okay? You shouldn't examine the patient anymore after declaration. And please remember, you can be sad. Yes, recognize this is not. Be supportive of the grief in the room. Be able to express your own grief and your own sadness. Make sure that you use all hospital support resources, chaplains, priests, your organ donation agency, social work, OPA, other support systems that you have available. Do set time limits for continued organ support. This is not something that you should have the family of how long can you continue doing this. Your policy should also have statements in it about how to manage disagreements with family if they occur. What about your relationships with your organ procurement organizations? I strongly encourage a respectful separateness. They actually may be able to help provide family support. They can help develop hand prints, make memories, do things. You can save the sound of the patient's heartbeat for their loved ones. We actually can take the sound of a heartbeat and put that into a small stuffed animal for children if that's something someone wants. So realize there are all these different supports and your organ procurement organization may be able to help provide those, but there cannot be any appearance of a conflict of interest. Keep yourself separate from them. Recognize that they can do good. They do a lot of good. They can be helpful, but don't make it look like you are, that there's any conflict of interest, that you are so closely aligned with them that their priorities are more rate higher for you than the patient's priorities. Your first priority is to the patient and to make sure that the management of the patient is appropriate based on their clinical findings. Okay, so in summary, from my part of this session, and I thank all of you for being here, we as intensivists need to be familiar with this process. You need to be aware of your state laws. Be prepared to address those. Update your local policies. Think of all the things I've talked about in doing it. Make sure your policies address all of the issues. Establish a process to maintain competency in this examination, and then do everything you can to make this examination standardized, that it's done the same way every single time so that people can trust this examination, they can believe you with what you're doing. You need to be 100% right, 100% of the time when you are declaring brain death. There is no room for error here. So use your hospital policies, work together as a team to put these in place. Base them off the revised guidelines. And at this point, we will wrap up, and I'm happy to address any questions. So thank you for your time and attention.

Dr. Lori Schetter

brain death guidelines

critical care community

standardization

provider education

telemedicine

family communication