Precision Ventilation vs Standard Care for Acute Respiratory Distress Syndrome

Part of paid clinical trials in Tucson, Arizona.

Sponsor: Beth Israel Deaconess Medical Center
Study ID: NCT06066502
Phase: PHASE3
Status: Recruiting

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Conditions

Acute Respiratory Distress Syndrome
Respiratory Failure

Eligibility Criteria

Sex: ALL
Age: 18 Years - N/A
Healthy Volunteers: Not accepted

Interventions

Precision ventilation — OTHER
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 — OTHER
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.

Study Details

The goal of this interventional study is to compare standard mechanical ventilation to a lung-stress oriented ventilation strategy in patients with Acute Respiratory Distress Syndrome (ARDS). Participants will be ventilated according to one of two different strategies. The main question the study hopes to answer is whether the personalized ventilation strategy helps improve survival.

Key Dates

Start date: Jun 24, 2024
Status verified: May 2026
Primary completion: Oct 1, 2029
Completion: Aug 31, 2030

Study Design

Enrollment: 1,100 participants (estimated)
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Arms

Experimental: Precision ventilation
Ventilator support will be calibrated to maintain the range of lung stress typical of relaxed breathing in healthy adults. The ventilator management protocol takes into account pleural pressure, tidal volume and driving pressure, fraction of inspired oxygen (FiO2) and oxygen saturation (SpO2), and positive end-expiratory pressure (PEEP) titration.
Active Comparator: Guided usual care
Ventilator support will be managed by the clinical team per usual care with select protocol-based guard rails to avoid practice extremes beyond the current body of evidence. PEEP titration will be performed by the clinical team within the limits set in. The allowable combinations of PEEP and FiO2 in the control arm reflect pre-intervention usual care observed at baseline in the recent large federally-funded multicenter ARDS trials.

Primary Outcome Measure

60-day mortality [ Time Frame: 60 days from randomization ]

Central Contacts

Valerie Goodspeed, MPH
6176328055
[email protected]
Nancy Ringwood, RN
617-724-9836
[email protected]

Locations (33)

Facility	City	State	ZIP	Site coordinators
University of Arizona	Tucson	Arizona	85724	Jarrod M Mosier, MD [email protected] Beth S Campbell, PhD [email protected]
University of Arkansas for Medical Sciences	Little Rock	Arkansas	72205	Harmeen Goraya, MD [email protected] Brandy Lee [email protected]
University of California, San Diego	La Jolla	California	92093	Robert Owens, MD [email protected] Pamela N Deyoung [email protected]
Cedar-Sinai Medical Center	Los Angeles	California	90048	Abirami Kumaresan, MD [email protected] Janice Emmanuella, DO [email protected]
University of California, Los Angeles Medical Center	Los Angeles	California	90024	Steven Y Chang, MD [email protected] Julia Vargas [email protected]
Stanford University	Palo Alto	California	94305	Joseph Levitt, MD [email protected] Rosemary Vojnik [email protected]
University of California, San Francisco	San Franciso	California	94143	Michael Matthay, MD [email protected] Hanjing Zhou, MPH [email protected]
University of Miami	Miami	Florida	33136	Alexander Fort, MD [email protected] Alessandro Colantuono Esaa [email protected]
Emory University / Grady Health System	Atlanta	Georgia	30322	Matthew R Thau, MD [email protected] Vidhi Javia [email protected]
University of Chicago	Chicago	Illinois	60637	Bhakti Patel, MD [email protected] Tasneem Tweel [email protected]
Beth Israel Deaconess Medical Center	Boston	Massachusetts	02215	Valerie Goodspeed, MPH [email protected] 617-632-8055 Daniel Talmor, MD MPH [email protected] 617-667-2902
Brigham and Women's Hospital	Boston	Massachusetts	02115	Jakob Wollborn, MD, PhD [email protected] Tayisha Examond [email protected]
Massachusetts General Hospital	Boston	Massachusetts	02114	Lorenzo Berra, MD [email protected] Cristina Mietto, MD [email protected]
Tufts Medical Center	Boston	Massachusetts	02111	Anthony Faugno, MD [email protected] Bipin Malla [email protected]
Lowell General Hospital	Lowell	Massachusetts	01854	Anthony Faugno, MD [email protected] Bipin Malla [email protected]
University of Michigan	Ann Arbor	Michigan	48109	Pauline K Park, MD [email protected] Norman Olbrich [email protected]
Mayo Clinic	Rochester	Minnesota	55905	Gustavo Cortes Puentes, MD [email protected]
New York City Health + Hospitals/ Bellevue	New York	New York	10016	Jeremy Beitler, MD [email protected] [email protected]
NYU Lagone Health	New York	New York	02114	Jeremy Beitler, MD MPH [email protected] Alexis Serra, MD MPH [email protected]
Albert Einstein College of Medicine/Montefiore Medical Center	The Bronx	New York	10461	Ari L Moskowitz, MD MPH [email protected]
Duke University Medical Center	Durham	North Carolina	27710	Christina Barkauskas, MD [email protected]
Atrium Health Wake Forest Baptist	Winston-Salem	North Carolina	27157	Kevin Gibbs, MD [email protected] Darija Ward, MBA [email protected]
University of Cincinnati	Cincinnati	Ohio	45267	Kristin Hudock, MD [email protected] Robert D Hite, MD [email protected]
Cleveland Clinic Foundation	Cleveland	Ohio	44195	Eduardo Mireles-Cabodevila, MD [email protected]
Ohio State University Wexner Medical Center	Columbus	Ohio	43210	Joshua A Englert, MD [email protected]
University of Oklahoma Health Sciences	Oklahoma City	Oklahoma	73104	Huimin Wu, MD [email protected] Blair Apple Hill [email protected]
Oregon Health & Science University	Portland	Oregon	97239	Akram Khan, MD [email protected] Jose Pena, MD [email protected]
Thomas Jefferson University	Philadelphia	Pennsylvania	19107	Michael Baram, MD [email protected]
Baylor College of Medicine / St. Luke's Medical Center	Houston	Texas	77030	Christopher Howard, MD [email protected] [email protected]
Intermountain Health	Murray	Utah	84107	Jennifer Edwards, MD [email protected] Sarah Duckworth [email protected]
University of Utah	Salt Lake City	Utah	84132	Andrew Freeman, MD [email protected] Lindsey Waddoups, MS [email protected]
University of Virginia	Charlottesville	Virginia	22908	Danny Theodore, MD [email protected] Jennifer Phillips [email protected]
University of Washingont/Harborview Medical Center	Seattle	Washington	98104	Nicholas J Johnson, MD [email protected] Frances Nagore [email protected]

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