The Variable Ventilation Trial (Part A) (NCT07791225)
A Bayesian, Operationally Seamless Adaptive Phase 2A/2B, Open-label, Multi-center, Randomized, Two-part Trial to Evaluate the Safety, Efficacy, and Optimal Tidal Volume Distribution of Variable Ventilation (VV) in Participants Undergoing Mechanical Ventilatory Support for Acute Respiratory Distress Syndrome
🩺 Plain-English Summary (8th-Grade Level)
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 can join: Review the eligibility criteria below.
Location: University of Alabama at Birmingham — Birmingham, Alabama
Age range: 21 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (5 Sites)
- University of Alabama at Birmingham — Birmingham, Alabama
- Baystate Health — Springfield, Massachusetts
- Montefiore Einstein — The Bronx, New York
- Oregon Health & Science University — Portland, Oregon
- Intermountain Health Intermountain Medical Center — Murray, Utah
📞 Contact the Study Coordinator
Phone: (617) 525-6642
Email: rbaron@bwh.harvard.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in ARDS (Acute Respiratory Distress Syndrome)
- Prospective Randomized Trial of Total Lung Protective Ventilation in Adult VV-ECMO Patients With Severe ARDS — Charlottesville, Virginia
- Ondansetron for the Prevention of Patient Self-Inflicted Lung Injury in Patients With ARDS - Pilot RCT — Montreal, Quebec
- Lung Injury is One of the Primary Causes of Morbidity and Mortality in Critically Ill Patients. These Patients Will be Monitored for: 1) Immune Cell Activation 2) Blood-based Biomarkers. In Vitro Models Derived From These Samples Will be Treated With Novel Agent PIP-2 to Evaluate Its Efficacy. — Philadelphia, Pennsylvania
- Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HT31-1 for Treating ARDS — Richmond, Virginia
Explore by condition: All ARDS (Acute Respiratory Distress Syndrome) clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.