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Can custom ventilation save more ARDS lungs?

NCT ID NCT06066502

Disease control Sponsor: Beth Israel Deaconess Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 30, 2026 · Updated 2 times

Summary

This study tests whether a personalized breathing machine strategy can improve survival in people with acute respiratory distress syndrome (ARDS), a severe lung condition. About 1,100 adults on ventilators will be randomly assigned to either standard care or a precision approach that adjusts settings based on each patient's lung mechanics. The main goal is to see if the personalized strategy reduces deaths within 60 days.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
precision ventilation strategy
What this could lead to
If successful, this personalized ventilation approach could reduce deaths from acute respiratory distress syndrome (ARDS) by tailoring breathing support to each patient's lung mechanics.
What could go wrong
This is a large phase 3 trial, but the intervention is complex and may not improve survival over standard care. Results may not apply to all ARDS patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 1,100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2024

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age ≥ 18 years 2. Ventilator-dependent ARDS, with all of the following (a-e): 1. Invasive ventilation with positive end-expiratory pressure (PEEP) ≥ 8 cm H2O or FiO2 ≥ 0.5 2. 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. 3. Bilateral lung opacities on chest imaging not fully explained by effusions, lobar collapse, or nodules 4. Respiratory failure not fully explained by heart failure or fluid overload 5. Onset within 1 week of clinical insult or new/worsening symptoms 3. 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 Exclusion Criteria: 1. Esophageal manometry already in use clinically 2. 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) 3. Gross barotrauma or chest tube inserted to treat barotrauma (note: chest tube inserted strictly for drainage of pleural effusion is not an exclusion) 4. 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 5. Ongoing severe coagulopathy (platelet \< 5000/μL or INR \> 4) 6. Extracorporeal membrane oxygenation (ECMO) or CO2 removal (ECCO2R) 7. Neuromuscular disease that impairs spontaneous breathing (including but not limited to amyotrophic lateral sclerosis, Guillain-Barré syndrome, spinal cord injury at C5 or above) 8. 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 9. End-stage chronic cirrhosis with Child-Pugh Class C (Section 12.3) 10. ICU admission for burn injury 11. Current ICU stay \> 2 weeks or acute care hospital stay \> 4 weeks 12. 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 13. 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. 14. Treating clinician refusal or unwilling to use protocol-specified ventilator settings/modes 15. Prisoner 16. Previous enrollment in this trial

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Conditions

The condition(s) this trial relates to.

acute respiratory distress syndrome adult acute respiratory distress syndrome Critical Illness respiratory failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute respiratory distress syndrome Respiratory failure

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    33 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Albert Einstein College of Medicine/Montefiore Medical Center

    RECRUITING

    The Bronx, New York, 10461, United States

  • Atrium Health Wake Forest Baptist

    RECRUITING

    Winston-Salem, North Carolina, 27157, United States

  • Baylor College of Medicine / St. Luke's Medical Center

    RECRUITING

    Houston, Texas, 77030, United States

  • Beth Israel Deaconess Medical Center

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Brigham and Women's Hospital

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • Cedar-Sinai Medical Center

    RECRUITING

    Los Angeles, California, 90048, United States

  • Cleveland Clinic Foundation

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Duke University Medical Center

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Emory University / Grady Health System

    NOT_YET_RECRUITING

    Atlanta, Georgia, 30322, United States

  • Intermountain Health

    RECRUITING

    Murray, Utah, 84107, United States

  • Lowell General Hospital

    NOT_YET_RECRUITING

    Lowell, Massachusetts, 01854, United States

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • NYU Lagone Health

    RECRUITING

    New York, New York, 02114, United States

  • New York City Health + Hospitals/ Bellevue

    RECRUITING

    New York, New York, 10016, United States

  • Ohio State University Wexner Medical Center

    RECRUITING

    Columbus, Ohio, 43210, United States

  • Oregon Health & Science University

    RECRUITING

    Portland, Oregon, 97239, United States

  • Stanford University

    RECRUITING

    Palo Alto, California, 94305, United States

  • Thomas Jefferson University

    RECRUITING

    Philadelphia, Pennsylvania, 19107, United States

  • Tufts Medical Center

    RECRUITING

    Boston, Massachusetts, 02111, United States

  • University of Arizona

    RECRUITING

    Tucson, Arizona, 85724, United States

  • University of Arkansas for Medical Sciences

    RECRUITING

    Little Rock, Arkansas, 72205, United States

  • University of California, Los Angeles Medical Center

    RECRUITING

    Los Angeles, California, 90024, United States

  • University of California, San Diego

    RECRUITING

    La Jolla, California, 92093, United States

  • University of California, San Francisco

    RECRUITING

    San Franciso, California, 94143, United States

  • University of Chicago

    RECRUITING

    Chicago, Illinois, 60637, United States

  • University of Cincinnati

    RECRUITING

    Cincinnati, Ohio, 45267, United States

  • University of Miami

    RECRUITING

    Miami, Florida, 33136, United States

  • University of Michigan

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • University of Oklahoma Health Sciences

    NOT_YET_RECRUITING

    Oklahoma City, Oklahoma, 73104, United States

  • University of Utah

    RECRUITING

    Salt Lake City, Utah, 84132, United States

  • University of Virginia

    RECRUITING

    Charlottesville, Virginia, 22908, United States

  • University of Washingont/Harborview Medical Center

    RECRUITING

    Seattle, Washington, 98104, United States

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