The Variable Ventilation Trial (Part A)

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Brigham and Women's Hospital
Study ID
NCT07791225
Status
Not Yet Recruiting

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Conditions

  • ARDS (Acute Respiratory Distress Syndrome)

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Variable Ventilation — DEVICE
    Strategy of mechanical ventilation based on varying tidal volume breath to breath to provide therapeutic benefits in patients with ARDS.
  • Conventional Ventilation — DEVICE
    Strategy of mechanical ventilation based on delivery of a constant size low tidal volume.

Study Details

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.

Key Dates

First listed
Aug 27, 2026
Start date
Feb 1, 2027
Status verified
Aug 2026
Primary completion
Feb 1, 2031
Completion
Aug 31, 2031

Study Design

Enrollment
20 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Variable Ventilation
    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.
  • Placebo Comparator: Conventional Ventilation
    Standard strategy of mechanical ventilation based on constant size low tidal volume implemented on a commercially available ventilator.

Primary Outcome Measure

Safety assessed by the incidence of pre-specified AEs over the first 24 hours [ Time Frame: Maximum of 24 hours of VV ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35294
Peter Morris, MD
[email protected]
Baystate HealthSpringfieldMassachusetts01199
Mark Tidswell, MD
[email protected]
Montefiore EinsteinThe BronxNew York10461
Luke Andrea
[email protected]
314-705-0925
Daniel Ceusters
[email protected]
Oregon Health & Science UniversityPortlandOregon97239-3098-
Intermountain Health Intermountain Medical CenterMurrayUtah84107
Jessica Reimer
[email protected]
Emma Murphy
[email protected]

Find similar trials in Birmingham, AL

By research site
University of Alabama at Birmingham· Birmingham, ALBaystate Health· Springfield, MAMontefiore Einstein· The Bronx, NYOregon Health & Science University· Portland, ORIntermountain Health Intermountain Medical Center· Murray, UT

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