Variable Ventilation for Acute Respiratory Distress Syndrome
(VV (A) Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Rebecca Baron, MD
Principal Investigator
Brigham and Women's Hospital
Are You a Good Fit for This Trial?
This trial is for adults with acute respiratory distress syndrome (ARDS) who need a ventilator to help them breathe. People must be stable enough to participate and not have other conditions that would make ventilation unsafe, as judged by the study team.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Stabilization
Participants undergo a period of stabilization on conventional ventilation
Variable Ventilation
Participants receive variable ventilation for safety and feasibility assessment
Conventional Ventilation
Participants return to conventional ventilation for comparison
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Variable Ventilation
Trial Overview
The study compares two ways of using a breathing machine: variable ventilation (where breath sizes change slightly each time) versus conventional ventilation (same size breaths). Each participant receives both methods in sequence to test safety and practicality.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Strategy of mechanical ventilation based on varying tidal volume breath to breath to provide therapeutic benefits in patients with ARDS. The variable ventilation (VV) strategy will be implemented on a commercially available ventilator.
Standard strategy of mechanical ventilation based on constant size low tidal volume implemented on a commercially available ventilator.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Brigham and Women's Hospital
Lead Sponsor
Baystate Medical Center
Collaborator
Boston University
Collaborator
Oregon Health and Science University
Collaborator
University of Alabama at Birmingham
Collaborator
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