Can varying breath size protect lungs on a ventilator?
NCT ID NCT07791225
First seen Aug 27, 2026 · Last updated Aug 28, 2026 · Updated 1 time
Summary
This trial tests whether a ventilator method called variable ventilation, which changes the size of each breath slightly, is safe and feasible for adults with acute respiratory distress syndrome (ARDS) who need breathing support. Participants receive 24 hours of variable ventilation between periods of standard ventilation, while researchers monitor for complications and check lung function. The goal is to see if this approach could offer a gentler alternative to the constant-size breaths used today.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Variable ventilation, a ventilator strategy that changes the size of each breath slightly, compared with conventional constant-size ventilation
- What this could lead to
- If it works, this could point toward a safer way to ventilate patients with ARDS, potentially reducing lung injury and improving recovery.
- What could go wrong
- This is an early, small safety study with only 20 participants, so results may not apply broadly. The intervention could still cause complications like barotrauma or worsening oxygenation.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Feb 2027
An estimate. Start dates often move.
- Expected to finish
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Aug 2031
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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21 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Patients ≥21 years old admitted to the Surgical, Trauma, Burn, Coronary or Medical ICUs with ARDS according to the Berlin criteria \[50\] and requiring mechanical ventilation will be eligible for inclusion. 2. Not more than 96 hours of mechanical ventilation before randomization 3. Anticipated need for at least 48 more hours of controlled mechanical ventilation 4. Intubated and mechanically ventilated for ARDS according to the Berlin criteria * Hypoxemia of acute onset, within the past 7 days * Mild or moderate hypoxemia, PaO2/FiO2 ratio 100 - 300 mm Hg * Presence of a risk factor for ARDS * Respiratory failure not fully explained by cardiac failure or fluid overload * Bilateral opacities not explained by effusions, lobar collapse, or nodules Exclusion Criteria: Demographic 1. Age less than 21 years 2. Pregnant or breastfeeding 3. Prisoner 4. Concurrent participation in another investigational drug study 5. Patient, surrogate, or physician not committed to full support (exception: a patient will not be excluded if they would receive all supportive care except for attempts at resuscitation from cardiac arrest) 6. No consent or inability to obtain consent or appropriate legal representative not available 7. Physician refusal to allow enrollment in the trial 8. Moribund patient not expected to survive 24 hours 9. Treating team unwilling to use ARDS network low tidal volume strategy or variable ventilation mode 10. Use, or planned use of ECMO 11. Stroke (ischemic or hemorrhagic) or traumatic brain injury (TBI) within the prior 3 months 12. Burns \> 40% total body surface area (TBSA) 13. Severe airway inhalational injury 14. Diffuse alveolar hemorrhage 15. Any of the following hallmarks of Severe COPD, Global Initiative for Chronic Obstructive Lung Disease (GOLD) grade 3 or 4 1. FEV1 \< 50% predicted 2. Resting arterial blood gas values PaO2\<55, SaO2\<88%, or PaCO2\>55 3. Home invasive or non-invasive ventilation other than for sleep apnea 4. Cor Pulmonale 5. Candidate for, or has received, lung volume reduction surgery, bronchoscopic intervention to reduce end-expiratory lung volume, or lung transplantation 16. Any of the following cardiac problems: 1. Acute myocardial infarction (MI) or acute coronary syndrome within the last 90 days 2. Coronary artery bypass graft (CABG) surgery within 30 days 3. Angina pectoris, or use of nitrates, with activities of daily living 4. Cardiopulmonary disease classified as NYHA class IV Physiological Exclusions 17. Evidence of current barotrauma (e.g., pneumothorax, pneumomediastinum, or subcutaneous emphysema) 18. Hemodynamic instability defined by inability to maintain a mean arterial pressure \> 60 mm Hg. 19. Other respiratory instability PEEP ≥18 cmH2O, suctioning more than hourly, Pplateau \> 35 cm H2O, severe respiratory acidosis pH\<7.25. 20. Increased ICP \> 20 cmH2O or mechanism of injury leading to concern for increased ICP 21. Active bleeding with hemodynamic instability.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
5 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Baystate Health
Springfield, Massachusetts, 01199, United States
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Intermountain Health Intermountain Medical Center
Murray, Utah, 84107, United States
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Montefiore Einstein
The Bronx, New York, 10461, United States
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Oregon Health & Science University
Portland, Oregon, 97239-3098, United States
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University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a different ventilator mode help ARDS patients breathe on their own faster?
- Can a smarter ventilator setting spare damaged lungs on ECMO?
- Can matching drugs to biology beat ARDS?
- Immune cell infusion aims to free ARDS patients from ventilators
- New ventilation strategy aims to reduce lung damage in severe pneumonia
- Scientists build a biobank to decode ARDS and personalize treatment