New oxygen method may speed recovery from High-Altitude lung condition
NCT ID NCT07536477
First seen Jun 27, 2026 · Last updated Aug 12, 2026 · Updated 2 times
Summary
This study tests if a special high-flow oxygen mask works better than standard oxygen for people with high-altitude pulmonary edema (fluid in the lungs from climbing too high too fast). About 200 adults who develop symptoms within 7 days of reaching high altitude will be randomly assigned to one of two oxygen treatments. The main goal is to see which method helps patients stop needing extra oxygen sooner.
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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 208 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2026
- Expected to finish
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Apr 2029
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.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Aged 18 years or older; 2. Onset of symptoms related to HAPE (including dyspnea at rest, cough, or exercise intolerance) within 7 days of ascending to high altitude (≥2500m); 3. Diagnosis of HAPE according to the STAR data reporting guidelines, requiring at least two symptoms (dyspnea at rest, cough, weakness/decreased exercise performance, or chest tightness/congestion) and two clinical signs (rales or wheezing in at least one lung field, central cyanosis, tachypnea, or tachycardia); 4. Radiographic evidence of pulmonary edema on chest X-ray or CT; 5. Refusal or inability to undergo immediate descent at the time of presentation; 6. Capability and willingness to provide written informed consent. Exclusion criteria: 1. Known or clinically confirmed pregnancy; 2. Requirement for emergency intubation (as assessed by the treating clinician) due to cardiac/respiratory arrest, hemodynamic instability, airway compromise, severe hypoxia, or impaired consciousness, etc; 3. Pulmonary edema or hypoxemia resulting from other medical conditions (e.g., cardiogenic pulmonary edema, sepsis, chronic obstructive pulmonary disease (COPD), pneumothorax, massive pleural effusion, chest trauma, etc.); 4. Glasgow Coma Scale (GCS) score ≤ 12; 5. PaCO₂ \> 55 mmHg; 6. Presence of high-altitude cerebral edema; 7. Receipt of any respiratory support therapy (other than conventional oxygen therapy) prior to admission; 8. Presence of any contraindication to conventional or nasal oxygen therapy; 9. Presence of severe medical conditions or abnormal clinical laboratory findings that, in the investigator's judgment, may pose a risk to the patient's safety or interfere with the study's execution and participant completion; 10. Current participation in other clinical trials; 11. Refusal to sign the informed consent form.
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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
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A doctor treating you
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Contacts and locations
Locations
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NO.953 Hospital
RECRUITINGXigazê, Tibet, 857000, China
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Other studies related to the condition(s) this trial covers.