Vanderbilt University Medical Center

David R Janz, MD, MSc
Louisiana State University School of Medicine 
Director of Medical Critical Care Services at University Medical Center. I earned my medical degree at the LSU School of Medicine New Orleans followed by completion of an Internal Medicine residency, Pulmonary/Critical Care fellowship and Masters of Science in Clinical Investigation at Vanderbilt University, Nashville, TN. I am board certified in Internal Medicine, Pulmonary Medicine, and Critical Care Medicine.

University of Alabama at Birmingham Medical Center
Dr. Russell received his initial medical training (MD) at the University of Texas Medical Branch with his internal medicine internship and residency completed at Vanderbilt University. Dr. Russell began a clinical and research fellowship in pulmonary and critical care medicine at UAB in 2014. Following his fellowship, he joined the UAB faculty in July 2017. His research and clinical interests relate to the role of neutrophils and extracellular vesicles in pulmonary diseases characterized by neutrophilic inflammation and parenchymal damage such as COPD and ARDS, as well as pragmatic clinical trials on the management of critically ill patients. Dr. Russell has published and presented work on endotracheal intubation, management of respiratory failure, pragmatic clinical trials in the MICU, neutrophils in COPD, matrikines in COPD, exhaled breath biomarkers in ARDS and extracellular vesicles in neutrophilic inflammation. His ongoing work explores the role of neutrophil-derived exosomes in matrix destruction and lung disease.

University of Alabama at Birmingham Medical Center
Dr. Sheetal Gandotra is a pulmonary physician who began her work at UAB in 2018. She received her medical degree from Saba University School of Medicine.

Brian E Driver, MD
Hennepin County Medical Center, Minneapolis, MN 

Dr. Driver is board certified in both Emergency Medicine and Internal Medicine. He has expertise in caring for all acute illness and injuries, with particular interests in emergency airway management and metabolic disorders.

Matthew E Prekker, MD MPH
Hennepin County Medical Center, Minneapolis, MN 

Through specialization in both Emergency Medicine and Pulmonary & Critical Care Medicine, Dr. Prekker provides acute care for patients in the Emergency Department and Medical ICU as well as maintaining a practice as a pulmonary consultant and clinic physician. He has special expertise in resuscitation from critical illness, including airway management, mechanical ventilation, and extracorporeal membrane oxygenation.

Stacy Trent, MD
Emergency Physician, Denver Health Medical Center, Denver, USA

Stacy A. Trent, MD, MPH is an emergency physician and Associate Director of Research in the Department of Emergency Medicine at Denver Health Medical Center.  Dr. Trent’s is a federally-funded researcher whose work focuses on examining and mitigating variation in evidence-based care for airway management, sepsis, and acute coronary syndrome.  Dr. Trent is a member of the executive committee for the Pragmatic Critical Care Research Group, is member of the NHLBI PETAL network serving as a site investigator for the CLOVERS study and is also a member of the NIH SIREN network. 

Twitter:  @drstrent

Director of the Coordinating Center: Jonathan D. Casey, MD, MSc – Vanderbilt University Medical Center

Jonathan D. Casey MD, MSc is an Assistant Professor of Medicine in the Division of Allergy, Pulmonary, and Critical Care Medicine at Vanderbilt University and a critical care physician in the Medical Intensive Care Unit at Vanderbilt University. Dr. Casey’s work focuses on embedding pragmatic comparative effectiveness trials of standard-of-care interventions into routine care in the emergency department and intensive care unit.  His work aims to answer long-standing questions in airway management, post-extubation respiratory support, extracorporeal membrane oxygenation, and COVID-19.  These efforts have resulted in multiple practice-changing trials published in the New England Journal of Medicine, the Journal of the American Medical Association, and the American Journal of Respiratory and Critical Care Medicine.  Dr. Casey serves as Chair of the Coordinating Center for the Pragmatic Critical Care Research Group and as a member of the NHLBI-funded PETAL Network and the CDC-funded IVY network.

Twitter:  @JonathanCaseyMD

Chair of the Steering Committee: Matthew W. Semler, MD, MSc – Vanderbilt University Medical Center

Matthew W. Semler MD, MSc is an Assistant Professor of Medicine and Biomedical Informatics in the Division of Allergy, Pulmonary, and Critical Care Medicine at Vanderbilt University. Dr. Semler is a critical care physician and Associate Director of the Medical Intensive Care Unit at Vanderbilt University. Dr. Semler’s federally-funded research identifies non-patient-centered variation in current clinical practice, embeds pragmatic randomized trials into clinical care to understand which treatments produce the best outcomes for which patients, and implements the results into practice. Randomized trials he has helped lead, including six published in the New England Journal of Medicine or JAMA, have challenged longstanding dogma around common practices in fluid management, airway management, and respiratory support. Dr. Semler serves as Chair of the Steering Committee for the Pragmatic Critical Care Research Group, co-director of the Inpatient Division of the Learning Healthcare System at Vanderbilt University, and a member of the protocol committee for trials within the NHLBI PETAL Network.

Journal: Journal of Neurotrauma
PMID: 35443809

Journal: American Journal of Respiratory and Critical Care Medicine
PMID: 35549663

For patients on a breathing machine, doctors may secure the breathing tube in place using either adhesive tape or an endotracheal tube fastener.  The ETTS Trial compared the securement technique of adhesive tape versus an endotracheal tube fastener for patients in the medical intensive care unit expected to require a breathing machine for more than 24 hours. Safety and efficacy of the two techniques were compared by evaluating the presence of lip ulcers, the tube becoming dislodged from the patient, ventilator-associated pneumonia, or facial skin tears. Results of the study showed that the use of the endotracheal tube fastener reduced the rate of lip ulcers, tube dislodgement, and skin tears compared to the use of adhesive tape. The findings suggest that using an endotracheal tube fastener will reduce the rate of these events, may improve patient safety, and may decrease the cost of care.

Background: The optimal securement method of endotracheal tubes is unknown but should prevent dislodgement while minimizing complications. The use of an endotracheal tube fastener might reduce complications among critically ill adults undergoing endotracheal intubation.

Methods: In this pragmatic, single-center, randomized trial, critically ill adults admitted to the medical intensive care unit (MICU) and expected to require invasive mechanical ventilation for greater than 24 h were randomized to adhesive tape or endotracheal tube fastener at the time of intubation. The primary endpoint was a composite of any of the following: presence of lip ulcer, endotracheal tube dislodgement (defined as moving at least 2 cm), ventilator-associated pneumonia, or facial skin tears anytime between randomization and the earlier of death or 48 h after extubation. Secondary endpoints included duration of mechanical ventilation and ICU and in-hospital mortality.

Results: Of 500 patients randomized over a 12-month period, 162 had a duration of mechanical ventilation less than 24 h and 40 had missing outcome data, leaving 153 evaluable patients randomized to tube fastener and 145 evaluable patients randomized to adhesive tape. Baseline characteristics were similar between the groups. The primary endpoint occurred 13 times in 12 (7.8%) patients in the tube fastener group and 30 times in 25 (17.2%) patients in the adhesive tape group (p = 0.014) for an overall incidence of 22.0 versus 52.6 per 1000 ventilator days, respectively (p = 0.020). Lip ulcers occurred in 4 (2.6%) versus 11 (7.3%) patients, or an incidence rate of 6.5 versus 19.5 per 1000 patient ventilator days (p = 0.053) in the fastener and tape groups, respectively. The endotracheal tube was dislodged 7 times in 6 (3.9%) patients in the tube fastener group and 16 times in 15 (10.3%) patients in the tape group (p = 0.03), reflecting incidences of 11.9 and 28.1 per 1000 ventilator days, respectively. Facial skin tears were similar between the groups. Mechanical ventilation duration and ICU and hospital mortality did not differ.

Conclusion: The use of the endotracheal tube fastener to secure the endotracheal tubes reduces the rate of a composite outcome that included lip ulcers, facial skin tears, or endotracheal tube dislodgement compared to adhesive tape.

Trial registration: ClinicalTrials.gov NCT03760510. Retrospectively registered on November 30, 2018.

Keywords: Critical care; Endotracheal tube; Endotracheal tube dislodgement; Facial skin tear; Intensive care units; Lip ulcer; Mechanical ventilation; Tube fastener.

Manuscript Title: “The effect of adhesive tape versus endotracheal tube fastener in critically ill adults: the endotracheal tube securement (ETTS) randomized controlled trial.”

Journal: Critical Care

PMID: 31064406

Patients in the intensive care unit who require treatment with a breathing machine may develop serious problems with blood pressure or heart rhythm while the breathing tube is being placed.  To learn whether problems with blood pressure or heart rhythms could be prevented by giving patients fluid through an IV, we led a research study called PREPARE.  The PREPARE trial included 337 patients from 8 intensive care units and one emergency department. The trial found that giving fluid through an IV did not prevent seriously low blood pressure, but that the fluid might have been helpful for some patients receiving oxygen through a mask before the procedure (called “non-invasive ventilation”).  These results suggested that IV fluid might prevent low blood pressure among patients on non-invasive ventilation prior to placement of a breathing tube And were the basis for the PREPAREII trial (described above).

Background: Tracheal intubation is common in the care of critically ill adults and is frequently complicated by hypotension, cardiac arrest, or death. We aimed to evaluate administration of an intravenous fluid bolus to prevent cardiovascular collapse during intubation of critically ill adults.

Methods: We did a pragmatic, multicentre, unblinded, randomised trial in nine sites (eight ICUs and one emergency department) around the USA. Critically ill adults (≥18 years) undergoing tracheal intubation were randomly assigned (1:1, block sizes of 2, 4, and 6, stratified by study site) to either an intravenous infusion of 500 mL of crystalloid solution or no fluid bolus. The primary outcome, assessed in the intention-to-treat population, was cardiovascular collapse, defined as a new systolic blood pressure <65 mm Hg; new or increased vasopressor receipt between induction and 2 min after tracheal intubation; or cardiac arrest or death within 1 h of tracheal intubation. Adverse events were assessed in the as-treated population. This trial, which is now complete, is registered with ClinicalTrials.gov, number NCT03026777.

Findings: Patients were enrolled from Feb 6, 2017, to Jan 9, 2018, when the data and safety monitoring board stopped the trial on the basis of futility. By trial termination, 337 (63%) of 537 screened adults had been randomly assigned. Cardiovascular collapse occurred in 33 (20%) of 168 patients in the fluid bolus group compared with 31 (18%) of 169 patients in the no fluid bolus group (absolute difference 1·3% [95% CI -7·1% to 9·7%]; p=0·76). The individual components of the cardiovascular collapse composite outcome did not differ between groups (new systolic blood pressure <65 mm Hg 11 [7%] in the bolus group vs ten [6%] in the no-bolus group, new or increased vasopressor 32 [19%] vs 31 [18%], cardiac arrest within 1 h seven [4%] vs two [1%], death within 1 h of intubation two [1%] vs one [1%]). In-hospital mortality was not significantly different in the fluid bolus group (48 [29%]) compared with no fluid bolus (59 [35%]).

Interpretation: Administration of an intravenous fluid bolus did not decrease the overall incidence of cardiovascular collapse during tracheal intubation of critically ill adults compared with no fluid bolus in this trial.

Funding: US National Institutes of Health.

Manuscript Title: “Effect of a fluid bolus on cardiovascular collapse among critically ill adults undergoing tracheal intubation (PrePARE): a randomised controlled trial.”

Journal: Lancet Respiratory Medicine

PMID: 31585796

Journal: American Journal of Respiratory and Critical Care Medicine
PMID: 35579619

What we need to learn

When a patient needs a breathing machine, a breathing tube is placed through the mouth and into the windpipe. Difficulty placing the breathing tube may cause serious problems with low oxygen levels, low blood pressure, or injury to the windpipe or lungs. To place the breathing tube, doctors use a tool called a “scope” to see past the tongue for placement of the breathing tube in the windpipe. Two types of “scope” are commonly used. One is called a “video laryngoscope” and another is called a “direct laryngoscope”. The DEVICE trial compared use of a video laryngoscope with use of a direct laryngoscope in 1,417 patients in 7 emergency departments and 10 intensive care units across the United States. The study showed that use of a video laryngoscope increased the probability of successful breathing tube placement on the first attempt.

Importance

For critically ill adults undergoing emergency tracheal intubation, failure to intubate the trachea on the first attempt occurs in up to 20% of cases and is associated with severe hypoxemia and cardiac arrest. Before the DEVICE trial it remained unknown whether use of a video laryngoscope or use of a direct laryngoscopes was better for patients.’

Objective

To compare the effect of use of a video laryngoscope versus a direct laryngoscope on successful intubation on the first attempt among critically ill adults undergoing tracheal intubation in the acute care setting. Design, setting, and participants: The DirEct Versus Video LaryngosCopE (DEVICE) trial was a multi-center, parallel-group, non-blinded, randomized clinical trial among 1,417 critically ill adults undergoing orotracheal intubation in 7 emergency departments and 10 ICUs in 11 medical centers across the United States.

Interventions

Patients were randomly assigned to the video laryngoscope group (n =705) or the direct laryngoscope group (n = 712).

Main outcomes and measures

The primary outcome was successful intubation on the first attempt. The secondary outcome was the incidence of severe complications.

Results

Among 1417 patients who were included in the final analysis, successful intubation on the first attempt occurred in 600 patients (85.1%) in the video-laryngoscope group and in 504 patients (70.8%) in the direct-laryngoscope group (absolute risk difference, 14.3 percentage points; 95% 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 and relevance: 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.

ClinicalTrials.gov Identifier: NCT05239195
Manuscript Title: Video versus Direct Laryngoscopy for Tracheal Intubation of
Critically Ill Adults.
Journal: New England Journal of Medicine
PMID: 37326325

More information

This study is called “Direct Versus Video Laryngoscope (DEVICE)” and is funded by the U.S. Department of Defense. Our goal is to learn whether a “scope” with a video screen or a “scope” without a video screen is better for placing a breathing tube and preventing problems with oxygen levels and blood pressure. Participating in this study will not impact the quality of care patients receive. For each patient:

• When the doctors feel a “scope” with a video screen would be best for a patient, the team will use a “scope” with a video screen.
• When the doctors feel that a “scope” without a video screen would be best for a patient, the team will use a “scope” without a video screen.
• When the doctors do not have a preference, the patient will be assessed against the inclusion / exclusion criteria and when appropriate, enrolled in DEVICE. Once the patient is enrolled in DEVICE, the type of “scope” is assigned randomly, meaning that every patient will have a fair and equal chance of getting either type of “scope.”

Questions

If you have any questions or concerns about this study, you may contact the Principal Investigator, Dr. Jonathan Casey. He will be glad to answer any study-related questions. Dr. Casey’s phone number is (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.

Participating Sites

Vanderbilt; Denver Health; Ochsner; University of Washington; Duke University; University of Alabama, Birmingham; Baylor, Scott &White; University of Colorado, Denver; Hennepin County Medical Center; Wake Forest; Brooke Army Medical Center, Beth Israel Deaconess,

Trial Update

On November 17^th 2022, the investigators were notified by the Data and Safety Monitoring Board that the DEVICE trial had met the prespecified stopping criteria at the time of the single interim analysis.  Enrollment in the trial was stopped and investigators and clinicians at participating sites were notified.

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.

Importance

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.

Objective

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.

Interventions

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.

Results

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).

Conclusions and relevance:

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

Journal: American Journal of Respiratory and Critical Care Medicine
PMID: 35212255

Journal: Journal of Intensive Care Medicine
PMID: 34898310

Journal: JAMA
PMID: 35707974

Journal: Lancet Respiratory Medicine
PMID: 31585796

Journal: JAMA
PMID: 35707974

Journal: American Journal of Respiratory and Critical Care Medicine
PMID: 35486860

Journal: JAMA Network Open
PMID: 3550322