Precision Ventilation vs Standard Care for Acute Respiratory Distress Syndrome

Recruiting now · Phase 3

Conditions studied: Acute Respiratory Distress Syndrome, Respiratory Failure

In brief

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 facts

Study ID

NCT06066502

Run by

Beth Israel Deaconess Medical Center

People needed

1100

Starts

2024-06-24

Expected to finish

2030-12-31

Last updated by the study team

2026-06-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 18 years
• Ventilator-dependent ARDS, with all of the following (a-e):
• Invasive ventilation with positive end-expiratory pressure (PEEP) ≥ 8 cm H2O or FiO2 ≥ 0.5
• Hypoxemia as characterized by: • If arterial blood gas (ABG) available: the partial pressure of oxygen in the arterial blood (PaO2)/FiO2 ≤ 300 mm Hg, or, • if ABG not available OR overt clinical deterioration in oxygenation since last ABG: SpO2/FiO2 ≤ 316 with SpO2 ≤ 97% (both conditions) on two representative assessments between 1 to 6 hours apart. • If patient is positioned prone or receiving inhaled pulmonary vasodilator at time of screening:
• Qualifying PaO2/FiO2 or SpO2/FiO2 (as defined above) that was recorded within the 6 hours immediately prior to initiating either of these therapies may be used for eligibility determination. • If PEEP has been increased by > 5 cm H2O within the last 12 hours immediately prior to screening:
• Qualifying PaO2/FiO2 or SpO2/FiO2 (as defined above) prior to PEEP increase may be used for eligibility determination if recorded within this 12-hour window.
• Bilateral lung opacities on chest imaging not fully explained by effusions, lobar collapse, or nodules
• Respiratory failure not fully explained by heart failure or fluid overload
• Onset within 1 week of clinical insult or new/worsening symptoms
• Early in ARDS course
• Full criteria for ARDS (#2 above) first met within previous 3 days
• Current invasive ventilation episode not more than 4 days duration
• Current severe hypoxemic episode (receipt of invasive ventilation, noninvasive ventilation, or high-flow nasal cannula) not more than 10 days duration

You may not qualify if…

• Esophageal manometry already in use clinically
• Severe brain injury: including suspected elevated intracranial pressure, cerebral edema, or Glasgow coma score (GCS) ≤ 8 directly caused by severe brain injury (e.g., ischemia or hemorrhage)
• Gross barotrauma or chest tube inserted to treat barotrauma (note: chest tube inserted strictly for drainage of pleural effusion is not an exclusion)
• Esophageal pathology that, in judgement of the site investigator, significantly increases risk of esophageal catheter placement, including high-risk esophageal varices, recent oropharyngeal or gastroesophageal surgery; or past esophagectomy
• Ongoing severe coagulopathy (platelet < 5000/μL or INR > 4)
• Extracorporeal membrane oxygenation (ECMO) or CO2 removal (ECCO2R)
• Neuromuscular disease that impairs spontaneous breathing (including but not limited to amyotrophic lateral sclerosis, Guillain-Barré syndrome, spinal cord injury at C5 or above)
• Any of the following severe chronic lung diseases: cystic fibrosis, acute bronchiectasis exacerbation, acute exacerbation of a chronic interstitial lung disease (ILD), chronic pulmonary hypertension (PH) on PH-targeted vasoactive medication, or lung transplant
• End-stage chronic cirrhosis with Child-Pugh Class C (Section 12.3)
• ICU admission for burn injury
• Current ICU stay > 2 weeks or acute care hospital stay > 4 weeks
• Moribund patient not expected to survive 24 hours as assessed by the study physician; if cardiopulmonary resuscitation (CPR) was provided, assessment for moribund status must occur at least 6 hours after CPR was completed
• Current limitation on life-sustaining care (other than do-not-resuscitate), or expectation by clinical team that a limitation on life-sustained care will be adopted within next 24 hours.
• Treating clinician refusal or unwilling to use protocol-specified ventilator settings/modes
• Prisoner
• Previous enrollment in this trial

Where it is running

• University of Washingont/Harborview Medical Center — Seattle, Washington, United States (enrolling)
• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States (enrolling)
• University of California, San Diego — La Jolla, California, United States (enrolling)
• University of California, Los Angeles Medical Center — Los Angeles, California, United States (enrolling)
• Cedar-Sinai Medical Center — Los Angeles, California, United States (enrolling)
• Stanford University — Palo Alto, California, United States (enrolling)
• University of California, San Francisco — San Franciso, California, United States (enrolling)
• University of Miami — Miami, Florida, United States (enrolling)
• University of Utah — Salt Lake City, Utah, United States (enrolling)
• University of Virginia — Charlottesville, Virginia, United States (enrolling)
• University of Arizona — Tucson, Arizona, United States (enrolling)
• University of Chicago — Chicago, Illinois, United States (enrolling)
• Tufts Medical Center — Boston, Massachusetts, United States (enrolling)
• Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
• Brigham and Women's Hospital — Boston, Massachusetts, United States (enrolling)
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (enrolling)
• University of Michigan — Ann Arbor, Michigan, United States (enrolling)
• Mayo Clinic — Rochester, Minnesota, United States (enrolling)
• NYU Lagone Health — New York, New York, United States (enrolling)
• New York City Health + Hospitals/ Bellevue — New York, New York, United States (enrolling)
• Albert Einstein College of Medicine/Montefiore Medical Center — The Bronx, New York, United States (enrolling)
• Duke University Medical Center — Durham, North Carolina, United States (enrolling)
• Atrium Health Wake Forest Baptist — Winston-Salem, North Carolina, United States (enrolling)
• University of Cincinnati — Cincinnati, Ohio, United States (enrolling)
• Cleveland Clinic Foundation — Cleveland, Ohio, United States (enrolling)

Full record on ClinicalTrials.gov

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