The Pragmatic Critical Care Research Group (PCCRG) is a network of emergency medicine, anesthesiology, and critical care clinicians and researchers at more than 25 hospitals across the United States that embeds pragmatic trials within clinical care to improve outcomes for acutely ill patients.

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Past Trials

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PREPAREII Trial

Jul 2022

Importance: Hypotension is common during tracheal intubation of critically ill adults and increases the risk of cardiac arrest and death. Whether administering an intravenous fluid bolus to critically ill adults undergoing tracheal intubation prevents severe hypotension, cardiac arrest, or death remains uncertain.

Objective: To determine the effect of fluid bolus administration on the incidence of severe hypotension, cardiac arrest, and death.

Design, setting, and participants: This randomized clinical trial enrolled 1067 critically ill adults undergoing tracheal intubation with sedation and positive pressure ventilation at 11 intensive care units in the US between February 1, 2019, and May 24, 2021. The date of final follow-up was June 21, 2021.

Interventions: Patients were randomly assigned to receive either a 500-mL intravenous fluid bolus (n = 538) or no fluid bolus (n = 527).

Main outcomes and measures: The primary outcome was cardiovascular collapse (defined as new or increased receipt of vasopressors or a systolic blood pressure <65 mm Hg between induction of anesthesia and 2 minutes after tracheal intubation, or cardiac arrest or death between induction of anesthesia and 1 hour after tracheal intubation). The secondary outcome was the incidence of death prior to day 28, which was censored at hospital discharge.

Results: Among 1067 patients randomized, 1065 (99.8%) completed the trial and were included in the primary analysis (median age, 62 years [IQR, 51-70 years]; 42.1% were women). Cardiovascular collapse occurred in 113 patients (21.0%) in the fluid bolus group and in 96 patients (18.2%) in the no fluid bolus group (absolute difference, 2.8% [95% CI, -2.2% to 7.7%]; P = .25). New or increased receipt of vasopressors occurred in 20.6% of patients in the fluid bolus group compared with 17.6% of patients in the no fluid bolus group, a systolic blood pressure of less than 65 mm Hg occurred in 3.9% vs 4.2%, respectively, cardiac arrest occurred in 1.7% vs 1.5%, and death occurred in 0.7% vs 0.6%. Death prior to day 28 (censored at hospital discharge) occurred in 218 patients (40.5%) in the fluid bolus group compared with 223 patients (42.3%) in the no fluid bolus group (absolute difference, -1.8% [95% CI, -7.9% to 4.3%]; P = .55).

Conclusions and relevance: Among critically ill adults undergoing tracheal intubation, administration of an intravenous fluid bolus compared with no fluid bolus did not significantly decrease the incidence of cardiovascular collapse.

Manuscript Title: “Effect of Fluid Bolus Administration on Cardiovascular Collapse Among Critically Ill Patients Undergoing Tracheal Intubation: A Randomized Clinical Trial”

All Publications

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

Jul 2022

Journal: Lancet Respiratory Medicine
PMID: 31585796

Featured PCCRG Publications

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“Effect of Fluid Bolus Administration on Cardiovascular Collapse Among Critically Ill Patients Undergoing Tracheal Intubation: A Randomized Clinical Trial”

Jul 2022

Journal: JAMA
PMID: 35707974

Letters to Editor

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Use of a Bougie vs Endotracheal Tube With Stylet and Successful Intubation on the First Attempt Among Critically Ill Patients Undergoing Tracheal Intubation-Reply.

Apr 2022

Journal: JAMA
PMID: 35438731

Past Trials

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BOUGIE Trial

Dec 2021

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. Whether using a tracheal tube introducer (“bougie”) increases the likelihood of successful intubation compared with using an endotracheal tube with stylet remains uncertain.

Objective: To determine the effect of use of a bougie vs an endotracheal tube with stylet on successful intubation on the first attempt.

Design, setting, and participants: The Bougie or Stylet in Patients Undergoing Intubation Emergently (BOUGIE) trial was a multicenter, randomized clinical trial among 1102 critically ill adults undergoing tracheal intubation in 7 emergency departments and 8 intensive care units in the US between April 29, 2019, and February 14, 2021; the date of final follow-up was March 14, 2021.

Interventions: Patients were randomly assigned to use of a bougie (n = 556) or use of an endotracheal tube with stylet (n = 546).

Main outcomes and measures: The primary outcome was successful intubation on the first attempt. The secondary outcome was the incidence of severe hypoxemia, defined as a peripheral oxygen saturation less than 80%.

Results: Among 1106 patients randomized, 1102 (99.6%) completed the trial and were included in the primary analysis (median age, 58 years; 41.0% women). Successful intubation on the first attempt occurred in 447 patients (80.4%) in the bougie group and 453 patients (83.0%) in the stylet group (absolute risk difference, -2.6 percentage points [95% CI, -7.3 to 2.2]; P = .27). A total of 58 patients (11.0%) in the bougie group experienced severe hypoxemia, compared with 46 patients (8.8%) in the stylet group (absolute risk difference, 2.2 percentage points [95% CI, -1.6 to 6.0]). Esophageal intubation occurred in 4 patients (0.7%) in the bougie group and 5 patients (0.9%) in the stylet group, pneumothorax was present after intubation in 14 patients (2.5%) in the bougie group and 15 patients (2.7%) in the stylet group, and injury to oral, glottic, or thoracic structures occurred in 0 patients in the bougie group and 3 patients (0.5%) in the stylet group.

Conclusions and relevance: Among critically ill adults undergoing tracheal intubation, use of a bougie did not significantly increase the incidence of successful intubation on the first attempt compared with use of an endotracheal tube with stylet.

Trial registration: ClinicalTrials.gov Identifier: NCT03928925.

Manuscript Title: “Bougie or Stylet In Patients Undergoing Intubation Emergently (BOUGIE) (BOUGIE)”

Published by: BMJ

PMID: 34035106

Featured PCCRG Publications

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“Effect of Use of a Bougie vs Endotracheal Tube With Stylet on Successful Intubation on the First Attempt Among Critically Ill Patients Undergoing Tracheal Intubation: A Randomized Clinical Trial.”

Dec 2021

Journal: NEJM
PMID: 34879143

Results of Randomized Trials

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Effect of Use of a Bougie vs Endotracheal Tube With Stylet on Successful Intubation on the First Attempt Among Critically Ill Patients Undergoing Tracheal Intubation: A Randomized Clinical Trial.

Dec 2021

Journal: NEJM
PMID: 34879143

News

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Passing of Dr. James Dargin

Nov 2021

April 16, 1978 ~ October 31, 2021 (age 43)

Obituary

James Matthew Dargin, MD, 43, of Nashua, died unexpectedly at his home on October 31, 2021. He is the beloved husband of Elizabeth (Caron) Dargin with whom he shared fifteen joyful and blessed years of marriage.

Jim, as he was known to family and friends, was born in Nashua, NH on April 16, 1978. He is the son of John P. and Virginia (Breed) Dargin of Nashua. Jim attended Bishop Guertin High School and then enrolled at Boston University for his Bachelor in Science and in turn a Doctorate in Medicine. He also completed his residency at BU, in Emergency Medicine, at Boston Medical Center, while living in South Boston. Thereafter, he completed a fellowship in Critical Care at the University of Pittsburgh Medical Center before returning to New England to practice. An intensivist in Pulmonary and Critical Care, he served for the past eleven years as a physician at the Lahey Hospital and Medical Center in Burlington, MA. During that time, he held many leadership roles and was awarded multiple awards for his work, in addition to pursuing research, teaching, and mentoring others. He was highly regarded and admired by his colleagues for his deep commitment to his vocation as a physician, both in terms of his care of his patients and his teaching of future physicians.

Well beyond medicine, Jim had a great curiosity and desire for learning, whether from reading, conversation, or exploration. He loved fishing, and also watching Red Sox and Patriots games with friends and family. Absolutely above all else, he cherished time spent with family, especially with his wife and children. He will forever be remembered as the strong and loving family man he was.

In addition to his parents John and Virginia, and his wife Beth, Jim is survived by his two daughters, Paige Marie and Meredith Ann Dargin of Nashua; his brother, John P. Dargin and his wife Kathie of Nashua and his nieces, Brianna and Emma; his sister-in-law, Jennifer Matsis of Milford and his nieces Alexandra and Ashleigh; his aunt, Ann Scalcione and her husband Robert; two uncles, Paul Dargin and Joseph Breed, as well as many cousins and extended family.  Jim was predeceased by his in-laws, Normand and Sandra Caron.

Relatives and friends are invited to Jim’s visitation on SUNDAY, November 7th from 3-6 PM at ROCHETTE FUNERAL HOME AND CREMATION SERVICES, 21 Kinsley Street, Nashua.
His funeral Mass will be held on MONDAY, November 8th at 10 AM at St. Joseph the Worker Parish, 777 W Hollis Street, Nashua. Interment will follow in St. Louis Cemetery, Nashua. In lieu of flowers, donations may be made in Jim’s name to Beth Israel Lahey Health, please visit 

https://secure3.convio.net/bidmc/site/Donation2?df_id=6143&mfc_pref=T&6143.donation=form1 

Observational Studies

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Safety and Feasibility of a Protocolized Daily Assessment of Readiness for Liberation From Venovenous Extracorporeal Membrane Oxygenation.

Nov 2021

Journal: Chest
PMID: 34166644

Observational Studies

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Safety and Feasibility of a Protocolized Daily Assessment of Readiness for Liberation From Venovenous Extracorporeal Membrane Oxygenation

Nov 2021

Journal: Chest
PMID: 34166644

Dissemination

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Embedding Pragmatic Trials into Emergency and Critical Care (Matthew W. Semler, MD, MSc; Jonathan D. Casey, MD, MSc)

Oct 2021
Embedding Pragmatic Trials into Emergency and Critical Care (Matthew W. Semler, MD, MSc; Jonathan D. Casey, MD, MSc)10/29/2021

Speakers
​Matthew W. Semler, MD, MSc
Assistant Professor
Vanderbilt Health

Jonathan D. Casey, MD, MSc
Assistant Professor
Vanderbilt Health

Topic: Embedding Pragmatic Trials into Emergency and Critical Care

Keywords: Pragmatic clinical trials; Study design; Comparative effectiveness trials; Treatment effect; SMART trial; PreVent trial; Exception from Informed Consent (EFIC)

Key Points: Emergency medical clinicians are faced with common decisions in everyday practice with little to no data from randomized clinical trials to help inform their decisions.Four barriers to comparative effectiveness trials in a critical care setting are a brief therapeutic window, patients with multiple co-morbidities, the inability of the patient to consent to research, and analyzing average treatment effect rather than individual treatment effect.The PreVent Trial studied the use of bag-mask ventilation to prevent hypoxemia for patients who had been administered anesthesia in preparation for intubation.Efficient, pragmatic trial procedures that don’t delay treatment enable comparative effectiveness randomized clinical trials to be conducted effectively.After 50 years of debate about bag-mask ventilation during this interval period, the PreVent Trial found that bag-mask ventilation cut the rate of hypoxemia by 50% without affecting aspiration.The SMART Trial was a cluster-randomized, multiple-crossover trial of fluid management that studied patient outcomes when Balanced Crystalloids were used versus Saline solution.The large sample size of over 15,000 patients provided the SMART trial with the power to detect that a balanced crystalloid fluid prevented Major Adverse Kidney Events in 1% of patients compared to Saline solution. /li>Exception from Informed Consent (EFIC), implemented in 1996 allows trials in emergency situations of the condition is life-threatening, existing treatments are unproven or unsatisfactory, and research involves no more than minimal risk.Analyzing Individual Treatment Effects will allow clinical providers to tailor their decisions to their individual patient.Discussion Themes

Clinical equipoise poses a challenge for comparative effectiveness trials.
Key to getting buy-in from clinician stakeholders is explaining the importance of the research to the pat

Trial Statistical Analysis Plans

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Protocol and statistical analysis plan for the Pragmatic Investigation of optimaL Oxygen Targets (PILOT) clinical trial.

Oct 2021

Journal: BMJ Open
PMID: 34711597

Dissemination

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ICU doctor ‘frustrated’ as COVID hospitalizations spike in Tennessee

Sep 2021

By: Emily Luxen

NASHVILLE, Tenn. (WTVF) — As the Labor Day weekend concludes, Tennessee continues to see a record-breaking number of people hospitalized with COVID-19.

The latest data from the Tennessee Department of Health reveals there are now 3,597 COVID patients hospitalized across the state. Of those, 1,020 are in ICUs. Before this record influx of COVID patients, the previous record was set back in January.

Recent Stories from newschannel5.com
The most recent numbers from Vanderbilt Health show of the 218 people hospitalized over the last 7 days, 190 were unvaccinated.

“We’re seeing lots of lots people who are unvaccinated who are sick enough to be in the hospital,” said Dr. Todd Rice, a critical care physician at Vanderbilt Health. “There is some exasperation from nurses. It’s like if you just would have got vaccinated, you likely wouldn’t be here.”
Dr. Rice has been treating COVID patients since the beginning of the pandemic. He said 18 months of grueling work has taken a toll on hospital staff.

“These patients are sick,” said Dr. Rice. “They take a ton of resources, energy and time.”
Dr. Rice said doctors are also waiting to see if travel and other activities over the Labor Day weekend cause yet another spike in cases.

“Our numbers are high enough right now, I think any increase we see gets buried in the high numbers right now.”

Dr. Rice said the only way to reverse the trend is for more Tennesseans to get vaccinated. He said some unvaccinated patients have expressed regrets they didn’t get the shot, and he hopes others learn from their actions.

“There is no better way to make sure you don’t get COVID and don’t end up in the hospital than to get yourself vaccinated,” said Dr. Rice.

Past Trials

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Proper

Aug 2021

Rationale: Respiratory support (noninvasive ventilation or high-flow nasal cannula) applied at the time of extubation has been reported to reduce reintubation rates, but concerns regarding effectiveness have limited uptake into practice.

Objectives: To determine if providing postextubation respiratory support to all patients undergoing extubation in a medical ICU would decrease the incidence of reintubation.

Methods: We conducted a pragmatic, two-armed, cluster-crossover trial of adults undergoing extubation from invasive mechanical ventilation between October 1, 2017, and March 31, 2019, in the medical ICU of an academic medical center. Patients were assigned to either protocolized postextubation respiratory support (a respiratory therapist-driven protocol in which patients with suspected hypercapnia received noninvasive ventilation and patients without suspected hypercapnia received high-flow nasal cannula) or usual care (postextubation management at the discretion of treating clinicians). The primary outcome was reintubation within 96 hours of extubation.

Measurements and Main Results: A total of 751 patients were enrolled. Of the 359 patients assigned to protocolized support, 331 (92.2%) received postextubation respiratory support compared with 66 of 392 patients (16.8%) assigned to usual care, a difference driven by differential use of high-flow nasal cannula (74.7% vs. 2.8%). A total of 57 patients (15.9%) in the protocolized support group experienced reintubation compared with 52 patients (13.3%) in the usual care group (odds ratio, 1.23; 95% confidence interval, 0.82 to 1.84; P = 0.32).

Conclusions: Among a broad population of critically ill adults undergoing extubation from invasive mechanical ventilation at an academic medical center, protocolized postextubation respiratory support, primarily characterized by an increase in the use of high-flow nasal cannula, did not prevent reintubation compared with usual care.Clinical trial registered with www.clinicaltrials.gov (NCT0328831).

Trial registration: ClinicalTrials.gov NCT03288311.

Keywords: invasive mechanical ventilation; noninvasive respiratory support; reintubation.

Manuscript Title: “Protocolized Postextubation Respiratory Support to Prevent Reintubation: A Randomized Clinical Trial.”

Journal: American Journal of Respiratory and Critical Care Medicine

PMID: 33794131

Secondary Analyses of Clinical Trial Results

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Balanced crystalloids versus saline in critically ill adults with low plasma bicarbonate: A secondary analysis of a clinical trial.

Jun 2021

Journal: Journal of Critical Care
PMID: 33500146

Secondary Analyses of Clinical Trial Results

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Balanced Crystalloids versus Saline in Critically Ill Adults with Hyperkalemia or Acute Kidney Injury: Secondary Analysis of a Clinical Trial.

May 2021

Journal: American Journal of Respiratory and Critical Care Medicine
PMID: 33503391

Trial Statistical Analysis Plans

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BOugie or stylet in patients UnderGoing Intubation Emergently (BOUGIE): protocol and statistical analysis plan for a randomised clinical trial.

May 2021

Journal: BMJ Open
PMID: 34035106

Dissemination

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Mastering Intensive Care Episode 66: Todd Rice – Learning and teaching how to “not just do something, stand there”

Feb 2021

This wide-ranging episode, covering many angles of how we should consider doing less interventions to our patients and more transparent communication to their families, features US intensivist Todd Rice.