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Patient Stakeholder Quotes

Sep 2024

Eileen Rubin, 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 is 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 a Patient Stakeholder for the RSI Trial.

Sherman Transou 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. In addition to serving on the Board of Directors for HonorBridge, he is an active advocate and leadership coach. Mr. Transou uses his experience to help research teams effectively connect with patients and their families. Mr. Transou is the Patient Stakeholder for Atrium Health Wake Forest Baptist.

Barbara Gould is a COVID intubation and liver transplant survivor and has personalexperience with post ICU syndrome and PTSD. As a retired social worker, Ms. Gouldunderstands the importance of patients’ physical and mental health and has used herexperience to platform the needs of patients and families. She shared, “I strongly believethat medical research saves lives and that patient representation in that process isessential.” Ms. Gould has spoken with the media about her hospitalization with COVID to raise awareness. She currently serves as the Patient Investigator for the University of Colorado Anschutz and the University of Colorado Denver.

Patrick Luther brings a wealth of knowledge to the RSI team as someone who has experience in advising the research enterprise at large, clinical trials in particular, and as a critical care survivor and former paramedic. Professionally, he works in nonprofit public health spaces developing and managing programs and community engaged research projects that address the needs of our most vulnerable while building their agency to take their place within research to change and improve it. His experiences provide
insight into patient communication and troubleshooting for trial implementation. Mr.
Luther is the Patient Stakeholder for Vanderbilt University Medical Center.

Jasmine McIntosh

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 the RSI Trial. “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.

News

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PREOXI Featured in First10EM

Jun 2024

News

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Featured in Journal Feed: PREOXI RCT – Preoxygenation with Noninvasive Ventilation vs. Non-rebreather Mask

Jun 2024

News

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Feature in HIPPO Education: Revolutionizing Preoxygenation: Insights from the PREOXI Trial

Jun 2024

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.

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PREOXI featured on Critical Care Time

Jun 2024

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!

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EMCrit 377 – Breaking News – The PREOXI Trial changes everything about Preoxygenation for Intubations in the Critically Ill

Jun 2024

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PREOXI featured on ICU Ed and Todd-Cast

Jun 2024

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.  

Mechanical Ventilation

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PILOT Trial

Jan 2024


Many patients in the intensive care unit (ICU) receive oxygen through a breathing
machine. Doctors, nurses, and respiratory therapist adjust the amount of oxygen given
through the breathing machine to target oxygen levels, but the ideal oxygen level to target
is unknown. To understand which oxygen level is best for patients, we conducted a
research study called the PILOT study. A total of 2,541 patients on breathing machines in
the Vanderbilt intensive care unit participated in the study and had their clinicians target
an oxygen level of 90%, 94%, or 98%. The results of the study suggested that patients
did equally well when their clinicians targeted an oxygen level of 90%, 94%, or 98%.
Background: Invasive mechanical ventilation in critically ill adults involves adjusting
the fraction of inspired oxygen to maintain arterial oxygen saturation. The oxygen-
saturation target that will optimize clinical outcomes in this patient population remains
unknown.

Methods

In a pragmatic, cluster-randomized, cluster-crossover trial conducted in the
emergency department and medical intensive care unit at an academic center, we
assigned adults who were receiving mechanical ventilation to a lower target for oxygen
saturation as measured by pulse oximetry (Spo2) (90%; goal range, 88 to 92%), an
intermediate target (94%; goal range, 92 to 96%), or a higher target (98%; goal range, 96
to 100%). The primary outcome was the number of days alive and free of mechanical
ventilation (ventilator-free days) through day 28. The secondary outcome was death by
day 28, with data censored at hospital discharge.

Results

A total of 2541 patients were included in the primary analysis. The median number of ventilator-free days was 20 (interquartile range, 0 to 25) in the lower-target group, 21 (interquartile range, 0 to 25) in the intermediate-target group, and 21 (interquartile range, 0 to 26) in the higher-target group (P = 0.81). In-hospital death by day 28 occurred in 281 of the 808 patients (34.8%) in the lower-target group, 292 of the 859 patients (34.0%) in the intermediate-target group, and 290 of the 874 patients (33.2%) in the higher-target group. The incidences of cardiac arrest, arrhythmia, myocardial infarction, stroke, and pneumothorax were similar in the three groups.

Conclusions

Among critically ill adults receiving invasive mechanical ventilation, the number of ventilator-free days did not differ among groups in which a lower, intermediate, or higher Spo2 target was used.

ClinicalTrials.gov Identifier:
NCT03537937.
Manuscript Title: Oxygen-Saturation Targets for Critically Ill Adults Receiving
Mechanical Ventilation
Journal: New England Journal of Medicine

PMID: 36278971

Antibiotics

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ACORN Trial

Jan 2024

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.

Importance

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.

Objective

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.

Interventions

Patients were randomized in a 1:1 ratio to cefepime or piperacillin- tazobactam.

Main outcomes and measures

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.

Results

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]).

Conclusions and relevance

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

Scientific Presentations

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The DEVICE Trial: An Embedded, Pragmatic Trial of Emergency Airway Management

Sep 2023

Location: NIH Collaboratory Grand Rounds
Presenter(s): Jon Casey and Matthew Prekker

Results of Randomized Trials

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Video versus Direct Laryngoscopy for Tracheal Intubation of Critically Ill Adults.

Aug 2023

Journal: New England Journal of Medicine
PMID: 37326325

Secondary Analyses of Clinical Trial Results

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Prophylactic Administration of Vasopressors Prior to Emergency Intubation in CriticallyIll Patients: A Secondary Analysis of Two Multicenter Clinical Trials

Jul 2023

Journal: Critical Care Explorations
PMID: 37457916

Secondary Analyses of Clinical Trial Results

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Individualized Treatment Effects of Bougie versus Stylet for Tracheal Intubation inCritical Illness

Jun 2023

Journal: American Journal of Respiratory and Critical Care Medicine
PMID: 36877594

Scientific Presentations

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DEVICE Trial Results

Jun 2023

Location: Critical Care Reviews Meeting 2023
Presenter(s): Matthew Prekker and Matt Semler

Uncategorized

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Protocol and Statistical Analysis Plan for the PREOXI Trial of Preoxygenation withNoninvasive Ventilation vs Oxygen Mask in Critically Ill Adults.

Mar 2023

Journal: CHEST Critical Care
oPMID: 36993496

Trial Statistical Analysis Plans

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Protocol and Statistical Analysis Plan for the Antibiotic Choice On ReNal Outcomes(ACORN) Randomised Clinical Trial.

Mar 2023

Journal: BMJ Open
PMID: 36898748

Uncategorized

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Effect of Laryngoscope Blade Size on First Pass Success of Tracheal Intubation inCritically Ill Adults

Mar 2023

Journal: Critical Care Explorations
PMID: 36895888

Uncategorized

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Effect of Laryngoscope Blade Size on First Pass Success of Tracheal Intubation inCritically Ill Adults

Mar 2023

Journal: Critical Care Explorations
PMID: 36895888

Trial Statistical Analysis Plans

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DirEct versus VIdeo LaryngosCopE (DEVICE): Protocol and Statistical Analysis Planfor a Randomised Clinical Trial in Critically Ill Adults Undergoing Emergency TrachealIntubation

Jan 2023

Journal: BMJ Open
PMID: 36639210

Letters to Editor

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Reply to: Extracorporeal membrane oxygenation transport for severe COVID-19 – why we can and should!

Dec 2022

Journal: American Journal of Respiratory and Critical Care Medicine
PMID: 35882061

Scientific Presentations

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Bougie Trial Results

Dec 2022

Scientific Presentations

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Pilot Trial Results

Dec 2022

Scientific Presentations

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Prepare II

Dec 2022

Results of Randomized Trials

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Oxygen-Saturation Targets for Critically Ill Adults Receiving Mechanical Ventilation.

Nov 2022

Journal: NEJM
PMID: 36278971