PREVENT VILI

About PREVENT VILI

PREVENT VILI is a Phase 3, multicenter, randomized clinical trial testing whether a personalized approach to mechanical ventilation can improve survival in patients with Acute Respiratory Distress Syndrome (ARDS).

The trial is sponsored by Beth Israel Deaconess Medical Center, in collaboration with NYU Langone Health and Massachusetts General Hospital, and the National Heart, Lung, and Blood Institute (NHLBI), and is funded by the National Institutes of Health (NIH). It is currently recruiting patients at over 30 sites across the United States.

Why this study matters

ARDS (Acute Respiratory Distress Syndrome) is a serious lung condition. It can be life-threatening. It also puts a heavy strain on patients, families, and hospitals. Doctors have made progress in how they use ventilators to treat ARDS, and more patients are surviving than before. Still, too many patients die from this condition.

Almost every patient with ARDS needs a ventilator to help them breathe. But the ventilator can sometimes hurt the lungs even more. Doctors call this ventilator-induced lung injury, or VILI.

PREVENT VILI is studying a new way to set the ventilator for each patient. This method uses two tools, called driving pressure and esophageal manometry, to measure the stress on a patient’s lungs. The goal is to keep that stress in the same range the lungs feel during normal, relaxed breathing. Researchers believe this approach may protect the lungs better than current usual care and help more patients survive.

What the study is testing

Participants in the study are randomly assigned to one of two ventilator management strategies. Both groups have a thin, soft catheter placed through the nose or mouth into the esophagus to measure pressure — a technique called esophageal manometry. What differs between the groups is how that information is used.

In this arm, the esophageal catheter is placed strictly so study staff can monitor respiratory mechanics for research purposes. The treating clinical team is masked to these pressure values throughout the study and does not use them to guide ventilator settings.

What the study hopes to learn

Primary question: Does the precision ventilation strategy reduce 60-day mortality compared with guided usual care in patients with ARDS?

The study will also evaluate:

• Whether precision ventilation improves clinical lung recovery, measured by the composite endpoint of days alive and free of the ventilator (AVF)
• Whether precision ventilation reduces injury to the lung’s air sacs (alveolar epithelial injury)
• Whether precision ventilation affects hemodynamic stability, measured by shock-free days through Day 14

Who can participate

The study is enrolling adults (18 years and older) who:

• Are on invasive mechanical ventilation
• Meet criteria for moderate or severe ARDS
• Are early in the course of their ARDS (within the first few days of diagnosis)

There are a number of additional medical criteria that determine eligibility, and every patient’s situation is different. The full list of inclusion and exclusion criteria is available on the official study registration at ClinicalTrials.gov. Because ARDS typically develops suddenly during a hospital stay, eligibility is generally assessed and discussed by the bedside clinical team rather than through self-referral — please see our Patients & Families page for more information.

Study details at a glance

Where the study is being conducted

PREVENT VILI is enrolling patients at over 30 academic medical centers across the United States. Visit our Participating Centers page for the full list of sites.

Learn more

Explore the full protocol, find a participating site, or reach out with questions.