Can adjusting breathing effort during ventilation improve lung function in ARDS?
NCT ID NCT07798154
First seen Sep 01, 2026 · Last updated Sep 02, 2026 · Updated 1 time
Summary
This trial tests how different levels of spontaneous breathing during a ventilation mode called APRV affect lung function in adults with moderate-to-severe acute respiratory distress syndrome (ARDS). Each participant receives three breathing conditions in random order: low, high, and fully suppressed spontaneous breathing. The study measures ventilation-perfusion mismatch, a key indicator of how well the lungs are working, using electrical impedance tomography. The goal is to find the optimal breathing level to improve gas exchange and lung mechanics in critically ill patients.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- APRV ventilation with different levels of spontaneous breathing
- What this could lead to
- If it works, this could help doctors choose the best breathing settings for ARDS patients to improve lung function and potentially reduce complications.
- What could go wrong
- This is a small, short-term physiological study with only 15 participants, so results may not apply broadly. It only measures immediate effects, not long-term outcomes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
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 15 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2026
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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18 to 80 years
- 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\. Age ≥18 and ≤80 years old. 2. Diagnosed with moderate-to-severe ARDS according to the 2023 global ARDS definition. 3\. Within 48 hours of invasive mechanical ventilation. After 1-hour low-tidal-volume pressure-controlled ventilation following ARDSnet strategy, arterial blood gas shows PaO₂/FiO₂ ≤ 150 mmHg. 4\. Written informed consent is obtained from the patient or their legal surrogate decision-maker after full explanation of the study by the principal investigator or authorized study physician. Exclusion Criteria: * 1\. Refractory shock defined as persistent hyperlactatemia and/or prolonged capillary refill time, fluid-resistant, requiring norepinephrine ≥ 0.5 μg/kg/min. 2\. Severe chronic medical conditions severely affecting cardiopulmonary function: severe chronic obstructive pulmonary disease, interstitial lung disease, pulmonary embolism, right-heart failure, pulmonary hypertension, or severe arrhythmia. 3\. Radiologically confirmed bronchopleural fistula, status post lobectomy, or other major thoracic surgery. 4\. Contraindications to electrical impedance tomography (EIT): extensive chest skin injury or infection, implanted cardiac pacemaker or defibrillator, etc. 5\. Contraindications for esophageal manometry placement: esophageal obstruction, perforation, severe esophageal varices, etc. 6\. Diaphragmatic hernia, severe chest wall deformity, or significant pulmonary bullae. 7\. Significant coagulation abnormalities (PT or APTT prolonged ≥2 times upper limit of normal, or INR\>2.0) with active bleeding risk. 8\. Severe intracranial hypertension (\>20 mmHg), severe traumatic brain injury (GCS ≤8), or neuromuscular disorders. 9\. Pregnant or breastfeeding women. 10. Patients already receiving ECMO therapy. 11. Expected survival time \<24 hours judged by attending physician. 12. Body mass index (BMI) \>35 kg/m². 13. Previously enrolled in this study or participating in other interventional clinical trials.
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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
1 site. 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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Wuhan Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022, China
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