High-flow nasal oxygen versus conventional oxygen for high-altitude pulmonary edema

High-flow Nasal Cannula Oxygen Therapy Versus Conventional Oxygen Therapy in Patients With High-altitude Pulmonary Edema: A Prospective Randomized Controlled Study

This study tests whether high-flow nasal cannula oxygen helps adults with high-altitude pulmonary edema breathe and recover faster than standard oxygen therapy.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Third Military Medical University (Academic / other)
• Locations: 1 site (Xigazê, Tibet)
• Trial ID: NCT07536477 on ClinicalTrials.gov

What this trial studies

This interventional comparison tests high-flow nasal cannula (HFNC) against conventional oxygen therapy (COT) in adults diagnosed with high-altitude pulmonary edema (HAPE) who cannot or will not descend. Eligible participants are 18 or older with symptom onset within seven days of ascent to ≥2500 m and radiographic pulmonary edema; pregnant patients and those needing emergency intubation are excluded. Treatment is delivered at NO.953 Hospital in Xigazê, Tibet, and investigators monitor respiratory support needs and clinical recovery endpoints. The aim is to see if HFNC provides more rapid or effective respiratory stabilization than conventional oxygen in the HAPE setting.

Who should consider this trial

Good fit: Adults (≥18) with radiographic evidence of HAPE, symptom onset within seven days of ascent to ≥2500 m, who are unable or unwilling to descend and can provide informed consent.

Not a fit: Patients who are pregnant, require emergency intubation, or are hemodynamically unstable are excluded and unlikely to benefit from enrollment in this protocol.

Why it matters

Potential benefit: If successful, HFNC could improve oxygenation and speed recovery in HAPE patients, potentially reducing the need for intubation or other invasive support.

How similar studies have performed: HFNC has demonstrated benefit in other forms of acute hypoxemic respiratory failure and pulmonary edema, but direct evidence in HAPE is limited.

Eligibility criteria

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.

Where this trial is running

Xigazê, Tibet

• NO.953 Hospital — Xigazê, Tibet, China (Recruiting)

Study contacts

• Principal investigator: Ye Fan, Dr. — Department of Respiratory Disease, Xinqiao Hospital, Third Military Medical University, 83 Xinqiao Zhengjie, Shapingba District, ChongQing 400000, China
• Study coordinator: Yiding Li, Dr.

Conditions High-altitude Pulmonary Edema; HAPE