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Procedure

Precision Ventilation for Acute Respiratory Distress Syndrome (PREVENT VILI Trial)

Phase 3

Recruiting

Led By Daniel Talmor, MD MPH

Research Sponsored by Beth Israel Deaconess Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥ 18 years

Moderate or severe ARDS, defined as meeting specific criteria related to invasive ventilation, hypoxemia, chest imaging, and respiratory failure

Must not have

Esophageal varix or stricture; recent oropharyngeal or gastroesophageal surgery; or past esophagectomy

Neuromuscular disease that impairs spontaneous breathing

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 60 days

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial studies two different ways to ventilate patients with ARDS to see which helps improve survival.

Who is the study for?

Adults over 18 with severe breathing problems due to Acute Respiratory Distress Syndrome (ARDS) can join this trial. They must be early in their ARDS course, currently on a ventilator, and not have been on it for more than 4 days. People with certain conditions like severe brain injury, recent major chest or stomach surgery, chronic lung issues, or those at high risk of bleeding are excluded.

What is being tested?

The study is testing two ways to help patients breathe using a machine: the usual method versus a new 'precision' approach tailored to reduce lung stress. The main goal is to see if the personalized method improves survival rates for people with ARDS.

What are the potential side effects?

While specific side effects aren't listed here, mechanical ventilation can sometimes lead to complications such as lung damage from too much pressure (barotrauma), infections like pneumonia, or injuries related to inserting the breathing tube.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have severe breathing problems needing a ventilator, with poor oxygen levels and lung images showing damage.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had issues or surgery related to my esophagus.

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I have a muscle condition that affects my ability to breathe on my own.

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I need extra oxygen daily, have lung scarring, or had a lung transplant.

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I have been in the ICU for more than 2 weeks or hospitalized for over 4 weeks.

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I am on high doses of medication to maintain my blood pressure.

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I am on a machine to help with my breathing or to remove CO2.

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I have a severe brain injury with a low Glasgow coma score.

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I have severe liver disease.

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I have had a chest tube inserted due to lung injury.

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I was admitted to the ICU for a burn injury.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 60 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~60 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 60 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

60-day mortality

Secondary study objectives

28-day mortality

Alive and Respiratory Support-Free

Alive and ventilator-free through 28 days

+1 more

Other study objectives

Alveolar epithelial injury biomarkers

Daily Sequential Organ Failure Assessment (SOFA) through Day 7

Duration of vasopressor support through Day 28

+10 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Precision ventilationExperimental Treatment1 Intervention

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.

Group II: Guided usual careActive Control1 Intervention

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.

0 / 12Eligibility criteria met