RecruitingNot ApplicableNCT07536477

High-flow Nasal Cannula Oxygen Therapy Versus Conventional Oxygen Therapy in 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


Sponsor

Third Military Medical University

Enrollment

200 participants

Start Date

Apr 25, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This study aims to evaluate whether High-flow Nasal Cannula Oxygen Therapy (HFNC) provides superior respiratory support compared to Conventional Oxygen Therapy (COT) in patients with High-Altitude Pulmonary Edema (HAPE).


Eligibility

Min Age: 18 Years

Inclusion Criteria6

  • Aged 18 years or older;
  • Onset of symptoms related to HAPE (including dyspnea at rest, cough, or exercise intolerance) within 7 days of ascending to high altitude (≥2500m);
  • 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);
  • Radiographic evidence of pulmonary edema on chest X-ray or CT;
  • Refusal or inability to undergo immediate descent at the time of presentation;
  • Capability and willingness to provide written informed consent.

Exclusion Criteria11

  • Known or clinically confirmed pregnancy;
  • 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;
  • 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.);
  • Glasgow Coma Scale (GCS) score ≤ 12;
  • PaCO₂ > 55 mmHg;
  • Presence of high-altitude cerebral edema;
  • Receipt of any respiratory support therapy (other than conventional oxygen therapy) prior to admission;
  • Presence of any contraindication to conventional or nasal oxygen therapy;
  • 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;
  • Current participation in other clinical trials;
  • Refusal to sign the informed consent form.

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Interventions

DEVICEHigh-flow Nasal Cannula Oxygen Therapy (HFNC)

High-flow Nasal Cannula (HFNC) therapy was administered using a dedicated system with integrated active humidification and a heated-wire circuit, delivered via a wide-bore nasal cannula.


Locations(1)

NO.953 Hospital

Xigazê, Tibet, China

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NCT07536477