Can a simple gas save lives in severe lung failure?
NCT ID NCT07334873
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether adding inhaled nitric oxide (iNO) to standard care helps adults with moderate-to-severe acute respiratory distress syndrome (ARDS) survive longer. About 536 participants will be randomly assigned to receive iNO or a placebo through their ventilator. The main goal is to see if iNO reduces deaths within 28 days and increases time off the ventilator.
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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 536 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2027
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 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: * Age ≥ 18 years. * Patients diagnosed with moderate-to-severe ARDS according to the 2023 Global (or international) criteria. Exclusion Criteria: * Known allergy to iNO. * Congenital methemoglobinemia. * End-stage chronic lung disease (e.g., lung cancer, prior pneumonectomy/lung transplant). * Shock (norepinephrine \>0.5 μg/kg/min or equivalent for \>6 hours) at treatment initiation. * Pulmonary hypertension (PASP \>45 mmHg by echo or mPAP ≥25 mmHg by catheterization). * Serum creatinine \>2.5 mg/dL (221 μmol/L). * Major bleeding (e.g., intracranial, pulmonary) or platelet count \<20×10⁹/L. * Expected ICU/mechanical ventilation \<24 hours. * Pre-enrollment ECMO therapy. * Any investigator-assessed unsuitability for the study.
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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
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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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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Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- New device aims to wean ventilator patients faster
- Ventilator study aims to Fine-Tune breathing support for ICU patients