← Back to Search

Procedure

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

Phase 3

Waitlist Available

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months from trial enrollment

Awards & highlights

PREVENT VILI Trial 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.Check my eligibility

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.See study design

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.

PREVENT VILI Trial Eligibility Criteria

Inclusion Criteria

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

Select...

I am 18 years old or older.

Select...

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

PREVENT VILI Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months from trial enrollment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months from trial enrollment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months from trial enrollment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

60-day mortality

Secondary outcome measures

28-day mortality

6-month mortality

A composite of alive and ventilator-free through 28 days

+5 more

Other outcome measures

Alveolar epithelial injury biomarkers

Daily Sequential Organ Failure Assessment (SOFA) through Day 7

Daily fluid balance through Day 7

+9 more

PREVENT VILI 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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Beth Israel Deaconess Medical CenterLead Sponsor

838 Previous Clinical Trials

13,009,392 Total Patients Enrolled

Columbia UniversityOTHER

1,433 Previous Clinical Trials

2,446,709 Total Patients Enrolled

Massachusetts General HospitalOTHER

2,936 Previous Clinical Trials

13,197,623 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what degree does Precision ventilation pose a risk to patients?

"Our team at Power gives precision ventilation a score of 3 as it is currently in its third phase of trial. This indicates that there are multiple rounds of data demonstrating the efficacy and safety associated with this treatment."

Answered by AI

Are there remaining vacancies for participants in this experiment?

"According to the information available from clinicaltrials.gov, this particular study is no longer seeking patients; it was originally posted on January 1st 2024 and last updated September 27th 2023. Despite this trial being closed for enrollment, there are still 1744 other medical trials actively recruiting participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Precision Ventilation vs Standard Care for Acute Respiratory Distress Syndrome

Daniel Talmor 2024. "Precision Ventilation vs Standard Care for Acute Respiratory Distress Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06066502.

All > Ards