An interventional study of Variable Ventilation and Conventional Ventilation in ARDS (Acute Respiratory Distress Syndrome), sponsored by Brigham and Women's Hospital. Not yet recruiting at 5 sites in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2026-08-27.
Sponsored by Brigham and Women's Hospital · Not applicable, Interventional, and Treatment
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Among 112 studies in Acute Lung Injury with a site in United States — 17 open to participants now, 19 under way, 1 of them phase 3. Acute Lung Injury · United States.
Among the 112 studies in Acute Lung Injury with a site in United States, this one is the 61st largest by planned enrollment of the 88 interventional ones that give a count, is one of 2 that started in 2027, is one of 21 with no phase, reaches primary completion later than 16 of the 18 other live ones, and was the 112th registered.
382 studies on the registry are indexed under Acute Lung Injury; 73 are open to participants now.
Browse Acute Lung Injury studies →17 of the 112 studies in Acute Lung Injury with a site in United States are open now. Recruiting first, the newest first:
National Heart, Lung, and Blood Institute (NHLBI) · Sites in United States
Ages 18–100
Prenosis, Inc. · Sites in United States
Ages 18+
Implicit Bioscience · Sites in United States
Ages 18+
HTIC, Inc · Sites in United States
Ages 18–65 · Healthy volunteers
University of Kentucky · Sites in United States
Ages 18–99 · Healthy volunteers
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 45 Acute Lung Injury studies recruiting now, 25 (56%) set no upper age limit and 8 (18%) stop at 75 or younger; 6 take children under 18; 7 take healthy volunteers.
This study: 21 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
112 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 16 · Phase 2 42 · Phase 3 17 · Phase 4 4
First in 2001; this study’s year is marked. 2 started in 2027.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 20 is below the median of 60 across 227 interventional studies indexed under Acute Lung Injury.
Median enrollment 68 across the 88 interventional studies, 135 across the 22 observational. Of the 79 that completed or were terminated, 40 (51%) have results posted.
This tab as a report to print or save as PDF → With an account.
26 of 112 have an industry lead sponsor. The 10 most frequent:
Brigham and Women's Hospital is the lead sponsor of 1,267 studies on the registry; 228 are open to participants now.
Of its 116 completed or terminated interventional studies of FDA-regulated products, 65 (56%) have results posted.
Brigham and Women's Hospital has 2 studies filed under Acute Lung Injury — fewer than ten, so there is no comparison to draw.
5 of the studies in Acute Lung Injury with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07125079University of PennsylvaniaLung 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. | 2026-12-20 |
| NCT07449572HTIC, IncClinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HT31-1 for Treating ARDS | 2027-01 |
| NCT06476132National Institute of Allergy and Infectious Diseases (NIAID)Belumosudil to Block Chronic Lung Allograft Dysfunction (CLAD) in High Risk Lung Transplant Recipients | 2027-05-30 |
| NCT04068012Children's Hospital Los AngelesClinical Decision Support Tool in PARDS Pilot Study | 2027-07 |
| NCT05977153The University of Texas Medical Branch, GalvestonCT for Personalized Mechanical Ventilation | 2027-08-31 |
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Among the 112 studies in Acute Lung Injury with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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:
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:
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Intubated and mechanically ventilated for ARDS according to the Berlin criteria
Exclusion Criteria:
Demographic
Any of the following hallmarks of Severe , Global Initiative for Chronic Obstructive Lung Disease (GOLD) grade 3 or 4
Any of the following cardiac problems:
Physiological Exclusions
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Variable Ventilation
Standard strategy of mechanical ventilation based on constant size low tidal volume implemented on a commercially available ventilator.
Device: Conventional Ventilation
Strategy of mechanical ventilation based on varying tidal volume breath to breath to provide therapeutic benefits in patients with ARDS.
Strategy of mechanical ventilation based on delivery of a constant size low tidal volume.
Safety assessed by the incidence of pre-specified AEs over the first 24 hours
Barotrauma
Time frame: Maximum of 24 hours of VV
Safety assessed by the incidence of pre-specified AEs over the first 24 hours
Worsening Hypoxemia
Time frame: Maximum of 24 hours of VV
Safety assessed by the incidence of pre-specified AEs over the first 24 hours
Worsening ventilation
Time frame: Maximum of 24 hours of VV
Safety assessed by the incidence of pre-specified AEs over the first 24 hours
New onset arrhythmia requiring cardioversion
Time frame: Maximum of 24 hours of VV
Safety assessed by the incidence of pre-specified AEs over the first 24 hours
Hemodynamic instability
Time frame: Maximum of 24 hours of VV
Safety assessed by the incidence of pre-specified AEs over the first 24 hours
ST-segment elevation myocardial infarction
Time frame: Maximum of 24 hours of VV
Safety assessed by the incidence of pre-specified AEs over the first 24 hours
Self-extubation
Time frame: Maximum of 24 hours of VV
Safety assessed by the incidence of pre-specified AEs over the first 24 hours
Stroke
Time frame: Maximum of 24 hours of VV
Safety assessed by the incidence of pre-specified AEs over the first 24 hours
Death
Time frame: Maximum of 24 hours of VV
Lung mechanics
Lung compliance, airways resistance, peak and plateau pressures
Time frame: Every 12 hours to maximum of 24 hours of VV
Gas exchange
SpO2, PaO2/FiO2 ratio, oxygenation index, dead space, and lung injury score.
Time frame: Every 12 hours to maximum of 24 hours of VV
Feasibility of VV implementation.
Qualitative feedback from Research and Clinical staff of the device and implementation in the ICU setting.
Time frame: Every 12 hours during 24 hours of VV
Plan to share: No — We will only be sharing data in agregate.
Start is estimated for Feb 2027; primary completion for Feb 2031, 48 months later.
Of 51 non-industry interventional studies with no phase under Acute Lung Injury, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 34. This study's planned 48 months is above that.
Counting every sponsor, half of 52 studies reached it within 15 months; a quarter within 7 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Brigham and Women's Hospital →