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High-flow Nasal Cannula Oxygen Therapy Versus Conventional Oxygen Therapy in High-altitude Pulmonary Edema

ConditionHigh-altitude Pulmonary Edema
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThird Military Medical University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • High-flow Nasal Cannula Oxygen Therapy (HFNC)

    Device

    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.

Treatment groups

208 Participants
are divided into 2 treatment groups
Group A: Intervention GroupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Proportion of treatment failure

Treatment failure: defined as the inability to achieve or maintain the target SpO2 despite optimized oxygen therapy, patient intolerance to the assigned oxygen therapy, or the need for treatment escalation (e.g., non-invasive ventilation or endotracheal intubation) and emergency descent to prevent further clinical deterioration.

Time frame
From date of randomization until the time of first documented treatment failure from any cause, assessed up to about 7 days.

Secondary outcomes

1

Time to weaning off supplemental oxygen

Hours from randomization to successful weaning to room air.

Time frame
From date of randomization to oxygen therapy completion (oxygen weaning), an average of 3-5 days.
2

The Net change in Lung CT Severity Score

Change in Lung CT Severity Score from baseline to Day 3 post-randomization

Time frame
Day 3
3

Evolvement of SpO2

SpO₂ is the percentage of oxygen-saturated hemoglobin in the blood, indicating how well oxygen is being delivered throughout the body. It was measured non-invasively using a pulse oximeter, a small device placed on a participant's fingertip, which uses light to estimate blood oxygen levels.

Time frame
From enrollment to treatment completion, an average of 3-5 days.
4

Incidence of oxygen therapy-related complications

Incidence of oxygen therapy-related complications during hospital stay.

Time frame
From randomization to discharge, assessed up to about 7 days.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Third Military Medical University

Lead sponsor

Source ClinicalTrials.gov
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