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The Variable Ventilation Trial (Part A)

NCT07791225 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-08-27

No results posted yet for this study

Summary

The goal of this clinical trial is to learn if a breathing machine (ventilator) method called "variable ventilation" can help protect the lungs of adult patients with acute respiratory distress syndrome (ARDS) who need help breathing through a ventilator. In variable ventilation, the size of each breath given by the machine changes slightly from breath to breath, instead of staying the same size in every breath. The study has two parts, A (safety and feasibility) and B (efficacy). This entry will cover the part A (safety study).

The main questions part A aims to answer are:

1. Is variable ventilation safe to use in adults with ARDS?
2. Is it feasible to deliver this method of ventilation to patients?

Researchers will compare variable ventilation to the standard breathing machine method used today to see if variable ventilation is safe and feasible.

Participants will be placed on an FDA approved ventilator that can deliver conventional mechanical ventilation and variable ventilation. Participants will:

* Have a period of stabilization on conventional ventilation, followed by 24 hours of variable ventilation, followed by 24 hours of conventional ventilation.
* Be checked regularly for breathing, oxygen levels, lung function, and plasma biomarkers.

Conditions

  • ARDS (Acute Respiratory Distress Syndrome)

Interventions

DEVICE

Variable Ventilation

Strategy of mechanical ventilation based on varying tidal volume breath to breath to provide therapeutic benefits in patients with ARDS.

DEVICE

Conventional Ventilation

Strategy of mechanical ventilation based on delivery of a constant size low tidal volume.

Sponsors & Collaborators

  • Baystate Medical Center

    collaborator OTHER

  • Boston University

    collaborator OTHER

  • Oregon Health and Science University

    collaborator OTHER

  • University of Alabama at Birmingham

    collaborator OTHER

  • Brigham and Women's Hospital

    lead OTHER

Principal Investigators

  • Rebecca Baron, MD · Brigham and Women's Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2027-02-01
Primary Completion
2031-02-01
Completion
2031-08-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07791225 on ClinicalTrials.gov