We start our Critical Care Reviews Down Under coverage with RSI talking with the first author of the “Ketamine versus Etomidate for Adults Receiving Emergency Endotrachael Intubation”, Jonathan Casey! We will pick up the rest of our CCR Down Under Coverage after the holiday break!
outlet: ICU-Ed and Todd-Cast podcast
Outlet: Hennepin airway podcast
outlet: Flightbridge ED podcast
To support seriously ill patients with a breathing machine, doctors must choose how the ventilator delivers each breath. Three common modes are volume control, pressure control, and adaptive pressure control, but whether mode choice affects outcomes was uncertain. The MODE trial compared these modes in 566 critically ill patients in a medical ICU. The study showed similar days alive and free from the ventilator across groups, with differences in breathing patterns that may warrant further study.
The MODE trial was a pragmatic, cluster-randomized, crossover pilot trial conducted in a medical ICU evaluating whether the choice of initial ventilator mode affects outcomes for critically ill adults receiving invasive mechanical ventilation. Patients were assigned by month to receive volume control, pressure control, or adaptive pressure control during continuous mandatory ventilation, and the primary outcome was ventilator-free days through 28 days. Among 566 patients, ventilator-free days were similar across groups (median 23, 22, and 24 days, respectively; P = .60). The trial demonstrated feasibility for testing ventilator mode using a pragmatic crossover design and identified differences in intermediate ventilation metrics that support evaluation in a larger trial.
When critically ill patients need a breathing machine, clinicians must choose a mode of mechanical ventilation. The three most common modes used for mandatory ventilation are volume control, pressure control, and adaptive pressure control, but it is uncertain whether the initial choice of ventilator mode affects outcomes. The MODE trial compared these commonly used ventilator modes in routine ICU care to evaluate whether mode selection influences duration of mechanical ventilation and patient outcomes.
Mechanical ventilation is a life-sustaining therapy in critical illness, but it can also contribute to lung injury and other complications. Before the MODE Trial, it was unknown whether the choice of ventilator mode during mandatory ventilation affects clinical outcomes for critically ill adults.
To determine the effects of volume control, pressure control, and adaptive pressure control ventilation modes on ventilator-free days through 28 days among critically ill adults receiving invasive mechanical ventilation.
In a pragmatic, cluster-randomized, crossover pilot trial conducted in a medical ICU between November 1, 2022, and July 31, 2023, patients were assigned by month to receive volume control, pressure control, or adaptive pressure control during continuous mandatory ventilation. The primary outcome was ventilator-free days through 28 days.
Among 566 patients included in the primary analysis, adherence to the assigned mode during the first 72 hours was high (median proportion of assessments in the assigned mode 100% in each group). The median number of ventilator-free days was 23 days in the volume control group, 22 days in the pressure control group, and 24 days in the adaptive pressure control group (P = .60). Intermediate ventilation patterns differed across groups, including the percentage of breaths with tidal volume >8 mL/kg predicted body weight, which was higher with pressure control than with volume control or adaptive pressure control.
In this pragmatic pilot trial, ventilator-free days were similar among patients assigned to volume control, pressure control, or adaptive pressure control. The trial demonstrated feasibility of a cluster-randomized crossover design for ventilator mode and identified differences in intermediate ventilation measures that support evaluation in a larger trial.
ClinicalTrials.gov Identifier: NCT05563779
Manuscript Title: Effect of Ventilator Mode on Ventilator-Free Days in Critically Ill Adults: A Randomized Clinical Trial
Journal: Chest
PMID: 40189043
Seitz KP, Lloyd BD, Wang L, Shotwell MS, Qian ET, Muhs AL, Richardson RK, Rooks JC, Hennings-Williams V, Sandoval CE, Richardson WD, Morgan TL, Thompson AN, Hastings PG, Ring TP, Stollings JL, Talbot EM, Krasinski DJ, DeCoursey BR, Marvi TK, DeMasi SC, Gibbs KW, Self WH, Mixon AS, Rice TW, Semler MW, Casey JD; Pragmatic Critical Care Research Group. Effect of Ventilator Mode on Ventilator-Free Days in Critically Ill Adults: A Randomized Clinical Trial. Chest. 2025 Oct;168(4):912-923. doi: 10.1016/j.chest.2025.03.024. Epub 2025 Apr 4. PMID: 40189043
To support critically ill patients, doctors often give intravenous fluids to improve circulation. Two common balanced fluids are Normosol-R and lactated Ringers, but whether one leads to better outcomes was unknown. The BASE trial compared these fluids in 2,084 critically ill patients at an academic medical center in the United States. The study showed similar acid-base measurements and clinical outcomes, including kidney replacement therapy and survival.
The BASE trial was a pragmatic, cluster-randomized, multiple-crossover trial conducted at an academic medical center comparing two commonly used balanced crystalloids—Normosol-R vs lactated Ringers—for IV fluid therapy in critically ill adults. Between June 2018 and January 2019, 2,084 patients were enrolled, and the primary outcome was plasma bicarbonate concentration through 7 days. Plasma bicarbonate values were similar between groups, and there were no meaningful differences in clinical outcomes including new kidney replacement therapy or 30-day mortality. These findings suggest that among balanced crystalloids, choosing Normosol-R rather than lactated Ringers does not improve acid-base status or patient-centered outcomes in critically ill adults.
Qian ET, Brown RM, Jackson KE, Wang L, Stollings JL, Freundlich RE, Wanderer JP, Siew ED, Bernard GR, Self WH, Casey JD, Rice TW, Semler MW; Pragmatic Critical Care Research Group. Normosol-R vs Lactated Ringers in the Critically Ill: A Randomized Trial. Chest. 2025 Aug;168(2):336-345. doi: 10.1016/j.chest.2025.02.008. Epub 2025 Feb 17. PMID: 39971001
Critically ill patients often receive intravenous fluids to support blood pressure, circulation, and organ perfusion. Two commonly used balanced crystalloid solutions are Normosol-R and lactated Ringers, which differ slightly in electrolyte composition and buffering agents. The BASE trial compared these fluids to determine whether the choice between balanced crystalloids affects acid-base status, kidney outcomes, or survival.
Balanced crystalloid solutions have been associated with improved outcomes compared with saline in some critically ill populations, but it is unclear whether clinically important differences exist between balanced crystalloids. Before the BASE Trial, whether choosing Normosol-R rather than lactated Ringers affects outcomes for critically ill adults was uncertain.
To determine whether use of Normosol-R compared with lactated Ringers affects plasma bicarbonate concentration through 7 days and clinical outcomes among critically ill adults.
In a pragmatic, cluster-randomized, multiple-crossover trial at an academic medical center in the United States, critically ill adults were assigned to receive Normosol-R or lactated Ringers for IV fluid therapy. The primary outcome was the plasma bicarbonate concentration between enrollment and 7 days. Secondary outcomes included new receipt of kidney replacement therapy and death by day 30.
Between June 2018 and January 2019, 2,084 patients were enrolled. Plasma bicarbonate concentration through 7 days did not differ between groups (mean difference, –0.12 mmol/dL; 95% CI, –0.61 to 0.36; P = .61). New kidney replacement therapy occurred in 6.0% of patients in the Normosol-R group and 5.0% in the lactated Ringers group (absolute risk difference, 1.0%; 95% CI, –1.2% to 3.1%). Death by day 30 occurred in 16.3% of patients in the Normosol-R group and 16.0% in the lactated Ringers group (absolute risk difference, 0.3%; 95% CI, –2.9% to 3.6%).
Among critically ill adults, use of Normosol-R did not improve plasma bicarbonate concentration or clinical outcomes compared with lactated Ringers. These findings suggest that among balanced crystalloids, the choice between these two solutions does not meaningfully change patient-centered outcomes.
ClinicalTrials.gov Identifier: NCT03537898
Manuscript Title: Normosol-R vs Lactated Ringers in the Critically Ill: A Randomized Trial
Journal: Chest
PMID: 39971001
To safely connect a patient to a breathing machine, doctors place a breathing tube through the mouth and between the vocal cords (intubation). A breathing tube can put pressure on a patient’s voice box and cause an ulcer (similar to how shoes can cause blisters on feet). If an ulcer develops, it can cause long-term problems with breathing, speaking, and swallowing even after the tube is taken out. Some breathing tubes are smaller and some are larger. Using smaller breathing tubes may prevent these long-term problems with breathing, speaking, and swallowing, whereas using larger breathing tubes may help patients get off of the breathing machine faster.
This research study is called the “Tube Size Randomized Trial during Emergency Tracheal Intubation” (BREATHE) and is funded by the Patient Centered Outcomes Research Institute (PCORI). The goal of the study is to learn whether smaller or larger breathing tubes (personalized for a patient’s height) are better for getting patients through their critical illness and preventing long-term problems with breathing, speaking, and swallowing.
Participating in this study will not impact the quality of care patients receive. For each patient:
The study team will:
If you have any questions or concerns about this study, you may contact the Principal
Investigator, Dr. Jonathan Casey at Jonathan.d.casey@vumc.org or (615) 208-6139. If
you have questions about your rights as a research participant, or concerns or
complaints about the research, you may also contact the Vanderbilt Human Research
Protections Program at (615)- 322-2918.
Some seriously ill patients in the hospital need help to breathe. In this situation a breathing machine – also known as a “mechanical ventilator” – is used to breathe for the patient while they heal. A breathing machine helps move air in and out of the lungs to maintain proper levels of oxygen in the blood. To use a breathing machine, the doctors and nurses insert a tube through the mouth to reach the lungs. The procedure for inserting a tube into the mouth to reach the lungs is called “intubation”.
Both smaller and larger breath tubes are used every day across the world. As far as we know today, both smaller and larger breathing tubes are equally safe and effective. However, it is possible that smaller breathing tubes could reduce the risk of injury to the voice box while larger breathing tubes help get patients through their illness and off the breathing machine faster. The goal of the BREATHE study is to determine if breathing tube size affects any of these risks.
Adults who are receiving treatment in a participating emergency room or intensive care unit (ICU) whose doctors have determined that they need a breathing tube may be eligible for this study. Patients are eligible only if their doctors and nurses think that using either a smaller or larger breathing tube would be consistent with optimal care for them. Patients can only participate if they are undergoing breathing tube placement at a hospital participating in the study. They cannot volunteer at any other time.
This work is supported through a Patient-Centered Outcomes Research Institute (PCORI) Project Program Award (BPS 2024C1-37478).
has experienced both emergency and extended intubation as the result of her being shot as a young adult. After weeks of being intubated and having a tracheostomy, she had to re-learn to swallow properly and to speak normally. “Over the past 50+ years, I’ve had countless surgeries/recoveries resulting from the original injury. Advising on this project is a way for me to further patient-centered care in emergency settings and planned procedures based on lessons I have learned. I’m grateful for the opportunity.” Since April 2022, Ms. Wilder served on the Patient Engagement Panel for the ADVANCE Collaborative, a Clinical Research Network led by OCHIN. Also, she has been an active advisor on AA-CONVENE, a research study using Artificial Intelligence to identify exposure to firearm violence in EHR clinical notes. Ms. Wilder is the Patient Stakeholder for the University of Washington.
is a COVID intubation survivor who was intubated for 19 days. After 42 days of combined hospitalization and rehab, she experienced brain fog and other symptoms of long-COVID. April is passionate about supporting research that is focused on improving outcomes for patients in the critical care space and hopes to use her patient experience and healthcare journey to provide support and guidance to research teams as they work to establish best practices. “I believe this research is important because it directly impacts millions of people who rely on the ventilator for survival and my hope is this will reduce symptoms and complications with prolonged intubation. Over 3 ½ years later I still feel the effects of my intubation.” Her background in logistics and customer service also provides expertise to help guide patient-facing study components. Mrs. Stovern serves as the Patient Stakeholder for the University of Minnesota Hennepin.
brings decades of experience as both a Nurse Practitioner and educator serving as the Dean of a College of Nursing. Her personal journey as a patient and two-time transplant survivor, however, provides incredible insight into the challenges of navigating a complex healthcare system. As a committed Advisory Council member, she provides recommendations to ensure that patient facing information is accessible and that the team considers patient and caregiver perspectives. “Being a patient representative on a research study team is an honor and a responsibility. I have the privilege to bring real voices into scientific discovery and to ensure that the human side of research is never forgotten.” Ms. Harden’s personal and professional backgrounds are uniquely well suited to provide patient-centered feedback to enhance clinical care and research. Ms. Harden serves as the Patient Stakeholder for Vanderbilt Health.
was diagnosed with airway stenosis in 2004 after two years of misdiagnosis, and her journey has included numerous surgeries and treatments, including a major airway reconstruction. She is the Founder and CEO of Living with Idiopathic Subglottic Stenosis community, now the largest global support group for airway stenosis patients. A frequent conference presenter and guest speaker, she is also an avid patient advocate with multiple publications in the clinical trial space. She brings extensive experience in patient recruitment, questionnaire design, and data interpretation centering the patient and caregiver experience. Catherine serves as a consultant to the North American Airway Collaborative at Vanderbilt Health and is professionally trained in market research and works with doctors to conduct research into iSGS and its treatments. Ms. Anderson serves as an organizational representative and Patient Stakeholder, representing the larger ISS patient community.
co-founder of the ARDS Foundation, has served as President and CEO for over two decades. An attorney by profession, Ms. Rubin experienced a life-altering diagnosis in her early 30’s that resulted in a lengthy ICU stay and long road to recovery. Today, she a well- known advocate for patients and their families serving in a variety of roles to help educate medical professionals and to improve and inform research. Ms. Rubin stresses, “Including the patient and family perspective is critical in medical research to ensure studies are designed from beginning to end with the patient in mind and with objectives focused on concerns, issues and endpoints of importance not only to advance medical research but also to include priorities of patients.“ She has served in an advisory capacity for numerous organizations including the American College of Chest Physicians, the Society of Critical Care Medicine and the American Thoracic Society. She was also the lead investigator for a PCORI Pipeline to Proposal Award. Ms. Rubin is an organizational representative and Patient Stakeholder providing insight on patient centeredness and dissemination priorities.
was an active business owner but in 2015 his life was changed when he learned that a virus was attacking his heart. Five months later he joined the growing community of transplant recipients and has embraced this opportunity to inspire and educate others in his community. With over 30 years of experience in leadership, client retention, and customer service, Sherman understands the urgency of fostering strong relationships and uses his background to prioritize the patient-centeredness of research. In addition to serving on the Board of Directors for HonorBridge, he is an active advocate, speaker and leadership coach. Mr. Transou uses his experience as a patient to help research teams effectively connect with patients and their families. Mr. Transou is the Patient Stakeholder for the Coordinating Site at Atrium Health Wake Forest Baptist.
is a COVID intubation and liver transplant survivor and has personal experience with post ICU syndrome and PTSD. As a retired social worker, Ms. Gould understands the importance of patients’ physical and mental health and has used her experience to platform the needs of patients and families. She shared, “I strongly believe that medical research saves lives and that patient representation in that process is essential.” Ms. Gould has spoken with the media about her hospitalization with COVID to raise awareness and most recently was the patient representative for the PCCRG group at the ATS 2025 International Conference. Ms. Gould serves as the Patient Investigator for the University of Colorado Anschutz and the University of Colorado Denver.
is a young adult cancer survivor who is an active advocate in the community. She is passionate about health inequities and supports research that is working to improve outcomes for all patients. Her background in systems and technology is an asset to clinical trials. “I believe clinical trial research is important because for me personally, as a two-time cancer survivor with a rare gene, research has allowed me to be on the receiving end of innovative care. I am grateful for that access as not everyone has that same opportunity. Research helps to make it more accessible and to continue the work toward health equity.” Ms. McIntosh is the Patient Stakeholder for the University of Alabama, Birmingham, providing guidance on community consultations and patient facing materials.
We welcome feedback and questions from the community about research like this. If you have comments or questions please contact Dr. Jonathan Casey at Jonathan.d.casey@vumc.org or (615) 208-6139
Doctors and scientists started the “Waveform capnography and colorimetric carbon dioxide detection during tracheal intubation of critically ill adults (WAVE)” study in April of 2025. This website provides information about the WAVE study.
The goal of the WAVE study is to determine whether one of the two methods that doctors commonly use to verify that a recently-placed breathing tube is correctly located in the windpipe (trachea) is best.
When doctors care for some patients who are very sick, a plastic breathing tube is inserted through the mouth and into the windpipe (called the trachea). A breathing machine (called a ventilator) is then connected to this plastic tube to help the patient breathe.
After the breathing tube is inserted, doctors must know for sure that it is in the correct place (the windpipe). If the breathing tube was accidentally inserted somewhere else, such as the passage that carries food to the stomach (the esophagus), air won’t reach the lungs, and the patient will get worse.
Doctors watch the breathing tube during placement to be sure that it correctly enters the windpipe. To confirm that it is inserted correctly, doctors use one of two simple tests at the bedside every time a breathing tube is inserted. Both tests work in a similar way—by looking for carbon dioxide in the breathing tube. Carbon dioxide is a substance that leaves the body only through your breath when you exhale so if carbon dioxide is detected coming from the breathing tube, the doctor knows it is in the correct place.
Both work and are used for millions of patients each year, but the study is trying to figure out if one is best.
Doctors and nurses are doing a research study to try and learn which carbon dioxide test is best for our patients who are very sick and need a breathing tube inserted. The study is named the WAVE Trial.
Normally a doctor would use either the waveform test or the color test right after the breathing tube is inserted to be sure it is in the correct location. In this study:
The doctors and nurses will care for all patients as they normally would, including using the information from both carbon dioxide tests to deliver the best care. Participating in this study will not change the quality of care that patients receive.
Placing seriously ill adults on a breathing machine is an emergency procedure. There is often no time for doctors to discuss the risks and benefits of the procedure. Patients are often unconscious or too sick to make decisions. So, doctors go ahead with life-saving care without the patient’s okay (consent).
For these same reasons, doctors may enroll patients in the WAVE Trial and collect information from both carbon dioxide tests after breathing tube insertion without getting the patient’s okay (consent). Important research to find the best emergency care, like the WAVE study, can sometimes be done without getting patients’ okay (consent) ahead of time through a process called “Waiver of informed consent”. Studies done with waiver of informed consent are reviewed by researchers, doctors, and an independent ethics committee.
Some seriously ill patients in the hospital need help to breathe. In this situation a breathing machine – also known as a “mechanical ventilator” – is used to breathe for the patient while they heal. A breathing machine helps move air in and out of the lungs to maintain proper levels of oxygen in the blood. To use a breathing machine, the doctors and nurses insert a tube through the mouth to reach the lungs. The procedure for inserting a tube into the mouth to reach the lungs is called “intubation”.
Adults who are receiving treatment in an emergency room or intensive care unit (ICU) whose doctors have determined that they need a breathing tube may be eligible for this study. Patients are eligible only if their doctors and nurses think that using both the color and waveform tests after intubation is safe for the patient. Patients can only participate if they are undergoing breathing tube placement at a hospital participating in the study. They cannot volunteer at any other time.
Both are FDA approved devices that are used every day by doctors to make sure the breathing tube is correctly positioned in the windpipe.
There are no known risks to either method of confirming the location of the tube. Both are used every day across the world. Normally your doctor would use either the waveform method or the colorimetry method to check tube location. In this study, your doctor used the information from both methods to confirm the tube is in the correct location.
The goal of the WAVE trial is to produce information that helps patients, families, and doctors choose the best test to check breathing tube placement so that patients can receive the best care possible. Making sure that patients, families, and community members know about the study and its findings is important to achieving this goal.
We welcome feedback and questions from the community about research like this. If you have comments or questions please contact Dr. Brian Driver at brian.driver@hcmed.org or call him at 612-873-7448.
When patients need a breathing machine, a breathing tube is placed through the mouth and into the windpipe. During placement of the breathing tube, patients may experience serious problems with low oxygen levels. Doctors give oxygen through a mask before the procedure to prevent low oxygen levels. Two types of oxygen mask are commonly used, non-invasive ventilation and facemask oxygen. Both provide oxygen. Non-invasive ventilation also provides positive pressure to open the lungs and provide breaths when a patient’s breathing slows or stops. Both types of masks are FDA approved and both are frequently used in emergency department (ED) and intensive care unit (ICU). The PREOXI study focused on determining if one type of mask is better than the other.
Among critically ill adults undergoing tracheal intubation, hypoxemia increases the risk of cardiac arrest and death. Before the PREOXI Trial, the effect of preoxygenation with noninvasive ventilation, as compared with preoxygenation with an oxygen mask, on the incidence of hypoxemia during tracheal intubation was uncertain.
To determine the effect of preoxygenation with noninvasive ventilation, as compared with preoxygenation with an oxygen mask, on the incidence of hypoxemia during tracheal intubation among critically ill adults. Design, setting, and participants: the PRagmatic trial Examining OXygenation prior to Intubation (PREOXI) was a multi-center, parallel-group, non-blinded, randomized clinical trial among 1,301 patients undergoing tracheal intubation in 24 emergency departments and intensive care units across the United States.
Patients were randomly assigned to receive preoxygenation with either noninvasive ventilation (n=645) or an oxygen mask (n=656). Main outcomes and measures: the primary outcome was hypoxemia during intubation, defined by an oxygen saturation of less than 85% during the interval between induction of anesthesia and 2 minutes after tracheal intubation. The secondary outcome was the lowest oxygen saturation during the interval between induction of anesthesia and 2 minutes after tracheal intubation.
Among the 1,301 patients enrolled, hypoxemia occurred in 57 patients (9.1%) in the noninvasive ventilation group and in 118 (18.5%) in the oxygen- mask group (difference, -9.4 percentage points; 95% confidence interval [CI], – 13.2 to -5.6; P<0.001). Cardiac arrest occurred in 1 patient (0.2%) in the noninvasive-ventilation group and in 7 patients (1.1%) in the oxygen-mask group (difference, -0.9 percentage points; 95% CI, -1.8 to -0.1_> Aspiration occurred in 6 patients (0.9%) in the noninvasive-ventilation group and in 9 patients (1.4%) in the oxygen-mask group (difference, -0.4 percentage points; 95% CI, -1.6 to 0.7).
| Ventilator Model | Manufacturer | NIV Capability | Required Software Version | |
|---|---|---|---|---|
| Puritan Bennett 980 | Medtronic | Yes | IE SyncTM Software Version 2.8 and Above | |
| Servo-I | Getinge Maquet | Yes | Base Software (v3.0 or higher) | |
| Servo-U | Getinge Maquet | Yes | Base Software (v2.0 or higher) | |
| Hamilton G5 | Hamilton Medical | Yes | Base Software (v2.0 or higher) | |
| Carescape R860 | General Electric (GE) | Yes | Base Software (v10 or higher) | |
| Infinity | C500 Dräger | Yes | SW 2.n | |
| Evita | XL Dräger | Yes | Software Version 4.n or higher, latest Version 6.0 | |
| Puritan Bennett 840 (PB840) | Medtronic | Yes | Software Version 7.3 or higher |
| Ventilator Model Puritan Bennett 980 |
|---|
| Manufacturer Medtronic |
| NIV Compatibilty Yes |
| Required Software IE SyncTM Software Version 2.8 and Above |
| Ventilator Model Servo-I |
|---|
| Manufacturer Getinge Maquet |
| NIV Compatibilty Yes |
| Required Software Base Software (v3.0 or higher) |
| Ventilator Model Servo-U |
|---|
| Manufacturer Getinge Maquet |
| NIV Compatibilty Yes |
| Required Software Base Software (v2.0 or higher) |
| Ventilator Model Hamilton G5 |
|---|
| Manufacturer Hamilton Medical |
| NIV Compatibilty Yes |
| Required Software Base Software (v2.0 or higher) |
| Ventilator Model Carescape R860 |
|---|
| Manufacturer General Electric (GE) |
| NIV Compatibilty Yes |
| Required Software Base Software (v10 or higher) |
| Ventilator Model Infinity |
|---|
| Manufacturer C500 Dräger |
| NIV Compatibilty Yes |
| Required Software Software Version 2.n |
| Ventilator Model Evita |
|---|
| Manufacturer XL Dräger |
| NIV Compatibilty Yes |
| Required Software Software Version 4.n or higher, latest Version 6.0 |
| Ventilator Model Puritan Bennett 840 (PB840) |
|---|
| Manufacturer Medtronic |
| NIV Compatibilty Yes |
| Required Software Software Version 7.3 or higher |
Among critically ill adults undergoing tracheal intubation, preoxygenation with noninvasive ventilation resulted in a lower incidence of hypoxemia during intubation than preoxygenation with an oxygen mask.
ClinicalTrials.gov Identifier: NCT05267652
Manuscript Title: Noninvasive Ventilation for Preoxygenation during Emergency
Intubation
Journal: New England Journal of Medicine
PMID: 38869091
Is there anything more bread and butter in emergency medicine than intubating patients in high-stress situations? With five million adults needing emergency intubation annually, staying updated on intubation best practices is crucial. The PRagmatic trial Examining OXygenation prior to Intubation (PREOXI), just published in the NEJM and discussed on ERcast in this free segment, could revolutionize our approach to preoxygenation and, most importantly, improve patient safety.
Extra Extra – Read All About It!! It is our pleasure to bring to you – hot off the presses – the results from the PREOXI Trial which looks at whether or not preoxygenation with non-invasive positive pressure ventilation results in better peri-intubation outcomes versus non-pressurized preoxygenation strategies. Joining us is the primary author on this paper, Dr. Kevin Gibbs, MD of Wake Forest University School of Medicine. Practice changing? Practice affirming? Does it even matter?! Check out our interview with Dr. Gibbs and see what you think!
Episode 40! In this special episode releasing at the conclusion of the PREOXI presentation at the Critical Care Reviews 2024 conference in Belfast, Ireland – we discuss the recently published PREOXI trial evaluating NIV vs facemask as pre-oxygenation for emergent endotracheal intubation. Kevin Gibbs, the first author and presenter at the conference, is our special guest.
Patients in the emergency department and intensive care unit who are suspected of having infections are treated with antibiotics. Most patients received either cefepime or piperacillin-tazobactam, antibiotics targeting resistant gram-negative bacteria. The two antibiotics are believed to have different risks. Cefepime may cause “neurotoxicity” (symptoms like agitation or coma). Piperacillin-tazobactam may cause kidney injury. To learn whether cefepime or piperacillin-tazobactam affects the chances of experiencing neurotoxicity or kidney injury, we conducted a research study called the ACORN study. A total of 1,172 patients receiving antibiotics for resistant gram-negative bacteria in the Vanderbilt Emergency Department or Intensive Care Unit participated in the study. The results of the study suggested that cefepime does cause neurotoxicity but piperacillin- tazobactam does not cause kidney injury and may be a safer alternative for patients being treated in the emergency department or intensive care unit.
Cefepime and piperacillin-tazobactam are commonly administered to hospitalized adults for empirical treatment of infection. Although piperacillin-tazobactam has been hypothesized to cause acute kidney injury and cefepime has been hypothesized to cause neurological dysfunction, their comparative safety has not been evaluated in a randomized clinical trial.
To determine whether the choice between cefepime and piperacillin- tazobactam affects the risks of acute kidney injury or neurological dysfunction. Design, setting, and participants: The Antibiotic Choice on Renal Outcomes (ACORN) randomized clinical trial compared cefepime vs piperacillin-tazobactam in adults for whom a clinician initiated an order for antipseudomonal antibiotics within 12 hours of presentation to the hospital in the emergency department or medical intensive care unit at an academic medical center in the US between November 10, 2021, and October 7, 2022. The final date of follow-up was November 4, 2022.
Patients were randomized in a 1:1 ratio to cefepime or piperacillin- tazobactam.
The primary outcome was the highest stage of acute kidney injury or death by day 14, measured on a 5-level ordinal scale ranging from no acute kidney injury to death. The 2 secondary outcomes were the incidence of major adverse kidney events at day 14 and the number of days alive and free of delirium and
coma within 14 days.
There were 2511 patients included in the primary analysis (median age, 58 years [IQR, 43-69 years]; 42.7% were female; 16.3% were Non-Hispanic Black; 5.4% were Hispanic; 94.7% were enrolled in the emergency department; and 77.2% were receiving vancomycin at enrollment). The highest stage of acute kidney injury or death was not significantly different between the cefepime group and the piperacillin-tazobactam group; there were 85 patients (n = 1214; 7.0%) in the cefepime group with stage 3 acute kidney injury and 92 (7.6%) who died vs 97 patients (n = 1297; 7.5%) in the piperacillin- tazobactam group with stage 3 acute kidney injury and 78 (6.0%) who died (odds ratio, 0.95 [95% CI, 0.80 to 1.13], P = .56). The incidence of major adverse kidney events at day 14 did not differ between groups (124 patients [10.2%] in the cefepime group vs 114 patients [8.8%] in the piperacillin-tazobactam group; absolute difference, 1.4% [95% CI, -1.0% to 3.8%]). Patients in the cefepime group experienced fewer days alive and free of delirium and coma within 14 days (mean [SD], 11.9 [4.6] days vs 12.2 [4.3] days in the piperacillin-tazobactam group; odds ratio, 0.79 [95% CI, 0.65 to 0.95]).
Among hospitalized adults in this randomized clinical trial, treatment with piperacillin-tazobactam did not increase the incidence of acute kidney injury or death. Treatment with cefepime resulted in more neurological dysfunction.
ClinicalTrials.gov Identifier: NCT05094154.
Manuscript Title: Cefepime vs Piperacillin-Tazobactam in Adults Hospitalized With
Acute Infection: The ACORN Randomized Clinical Trial.
Journal: JAMA
PMID: 37837651
Location: NIH Collaboratory Grand Rounds
Presenter(s): Jon Casey and Matthew Prekker
Journal: New England Journal of Medicine
PMID: 37326325
Background: Whether video laryngoscopy as compared with direct laryngoscopy increases the likelihood of successful tracheal intubation on the first attempt among critically ill adults is uncertain.
Methods: In a multicenter, randomized trial conducted at 17 emergency departments and intensive care units (ICUs), we randomly assigned critically ill adults undergoing tracheal intubation to the video-laryngoscope group or the direct-laryngoscope group. The primary outcome was successful intubation on the first attempt. The secondary outcome was the occurrence of severe complications during intubation; severe complications were defined as severe hypoxemia, severe hypotension, new or increased vasopressor use, cardiac arrest, or death.
Results: The trial was stopped for efficacy at the time of the single preplanned interim analysis. Among 1417 patients who were included in the final analysis (91.5% of whom underwent intubation that was performed by an emergency medicine resident or a critical care fellow), successful intubation on the first attempt occurred in 600 of the 705 patients (85.1%) in the video-laryngoscope group and in 504 of the 712 patients (70.8%) in the direct-laryngoscope group (absolute risk difference, 14.3 percentage points; 95% confidence interval [CI], 9.9 to 18.7; P<0.001). A total of 151 patients (21.4%) in the video-laryngoscope group and 149 patients (20.9%) in the direct-laryngoscope group had a severe complication during intubation (absolute risk difference, 0.5 percentage points; 95% CI, -3.9 to 4.9). Safety outcomes, including esophageal intubation, injury to the teeth, and aspiration, were similar in the two groups.
Conclusions: Among critically ill adults undergoing tracheal intubation in an emergency department or ICU, the use of a video laryngoscope resulted in a higher incidence of successful intubation on the first attempt than the use of a direct laryngoscope. (Funded by the U.S. Department of Defense; DEVICE ClinicalTrials.gov number, NCT05239195.).
Copyright © 2023 Massachusetts Medical Society.
Journal: Critical Care Explorations
PMID: 37457916
Journal: American Journal of Respiratory and Critical Care Medicine
PMID: 36877594
Location: Critical Care Reviews Meeting 2023
Presenter(s): Matthew Prekker and Matt Semler
Journal: BMJ Open
PMID: 36898748
Journal: CHEST Critical Care
oPMID: 36993496
Journal: Critical Care Explorations
PMID: 36895888
