1,100
Participants
Start Date
June 24, 2024
Primary Completion Date
October 1, 2029
Study Completion Date
August 31, 2030
Precision ventilation
The intervention arm prioritizes mitigation of ventilator-induced-lung-injury by individualizing support to patient-specific mechanics in an integrated approach to limit overdistension and atelectrauma. This is accomplished in this arm by titration of tidal volume to limitation of driving pressure at 12 centimeters of water (cmH2O) or less and using esophageal manometry to titrate PEEP to a transpulmonary pressure of 0 cmH2O with adjustments in respiratory rate to allow for permissive hypercapnia and FiO2 adjustments to assure adequate oxygenation.
Guided usual care ventilation
The comparison arm allows clinician discretion when titrating PEEP and tidal volume, while setting general targets for allowable PEEP/FiO2 combinations, target range for SpO2, and target range for tidal volume. This arm applies routine best-practice guidelines. This includes maintenance of tidal volumes of 6-8 cc/kg of ideal body weight, limiting plateau pressures to 30 cmH2O or less and application of PEEP-FiO2 combinations which include a wide range of typical usual care with esophageal manometry only for data collection and not clinical adjustment.
RECRUITING
New York City Health + Hospitals/ Bellevue, New York
RECRUITING
Albert Einstein College of Medicine/Montefiore Medical Center, The Bronx
RECRUITING
Atrium Health Wake Forest Baptist, Winston-Salem
NOT_YET_RECRUITING
Duke University Medical Center, Durham
RECRUITING
Ohio State University Wexner Medical Center, Columbus
RECRUITING
Cleveland Clinic Foundation, Cleveland
RECRUITING
University of Cincinnati, Cincinnati
RECRUITING
University of Michigan, Ann Arbor
RECRUITING
University of Chicago, Chicago
RECRUITING
Baylor College of Medicine / St. Luke's Medical Center, Houston
RECRUITING
Intermountain Health, Murray
RECRUITING
University of Utah, Salt Lake City
RECRUITING
University of Arizona, Tucson
RECRUITING
University of California, Los Angeles Medical Center, Los Angeles
RECRUITING
Cedar-Sinai Medical Center, Los Angeles
NOT_YET_RECRUITING
University of California, San Diego, La Jolla
RECRUITING
University of California, San Francisco, San Franciso
RECRUITING
Oregon Health & Science University, Portland
RECRUITING
University of Washingont/Harborview Medical Center, Seattle
RECRUITING
Tufts Medical Center, Boston
RECRUITING
Massachusetts General Hospital, Boston
RECRUITING
NYU Lagone Health, New York
NOT_YET_RECRUITING
Brigham and Women's Hospital, Boston
RECRUITING
Beth Israel Deaconess Medical Center, Boston
NYU Langone Health
OTHER
Massachusetts General Hospital
OTHER
National Heart, Lung, and Blood Institute (NHLBI)
NIH
Beth Israel Deaconess Medical Center
OTHER