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NCT07536477
High-flow Nasal Cannula Oxygen Therapy Versus Conventional Oxygen Therapy in High-altitude Pulmonary Edema
Conditions: High-altitude Pulmonary Edema
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 208
Sponsor: Third Military Medical University
Location: NO.953 Hospital Xigazê Tibet
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 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.
Source: ClinicalTrials.gov (NCT07536477). StuddyBuddy aggregates publicly available trial information.