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

April 28, 2026 updated by: Ye Fan, Third Military Medical University

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Conventional Oxygen Therapy (COT) is the established first-line treatment for High-Altitude Pulmonary Edema (HAPE). Despite the proven efficacy of High-flow Nasal Cannula (HFNC) in treating other forms of acute respiratory failure and pulmonary edema, its clinical role in the context of HAPE remains poorly defined. To address this gap, the investigators conducted a study comparing the efficacy of HFNC versus COT in providing respiratory support and accelerating clinical recovery for patients with HAPE.

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Yiding Li, Dr.
  • Phone Number: +86 13101377031
  • Email: fygan@163.com

Study Locations

  • China
    • Tibet
      • Xigazê, Tibet, China, 857000
        • Recruiting
        • NO.953 Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group
High-flow Nasal Cannula Oxygen Therapy (HFNC) plus standard medical management
Device: High-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.
No Intervention: Control Group
Conventional Oxygen Therapy (COT) plus standard medical management

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to weaning off supplemental oxygen
Time Frame: From date of randomization to oxygen therapy completion (oxygen weaning), an average of 3-5 days.
Hours from randomization to successful weaning to room air.
From date of randomization to oxygen therapy completion (oxygen weaning), an average of 3-5 days.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of treatment failure
Time Frame: From date of randomization until the time of first documented treatment failure from any cause, assessed up to about 7 days.
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.
From date of randomization until the time of first documented treatment failure from any cause, assessed up to about 7 days.
The Net change in Lung CT Severity Score
Time Frame: Day 3
Change in Lung CT Severity Score from baseline to Day 3 post-randomization
Day 3
Evolvement of SpO2
Time Frame: From enrollment to treatment completion, an average of 3-5 days.
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.
From enrollment to treatment completion, an average of 3-5 days.
Incidence of oxygen therapy-related complications
Time Frame: From randomization to discharge, assessed up to about 7 days.
Incidence of oxygen therapy-related complications during hospital stay.
From randomization to discharge, assessed up to about 7 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Third Military Medical University

Investigators

  • Principal Investigator: Ye Fan, Dr., Department of Respiratory Disease, Xinqiao Hospital, Third Military Medical University, 83 Xinqiao Zhengjie, Shapingba District, ChongQing 400000, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 25, 2026

Primary Completion (Estimated)

April 22, 2029

Study Completion (Estimated)

April 22, 2029

Study Registration Dates

First Submitted

April 3, 2026

First Submitted That Met QC Criteria

April 11, 2026

First Posted (Actual)

April 17, 2026

Study Record Updates

Last Update Posted (Actual)

May 4, 2026

Last Update Submitted That Met QC Criteria

April 28, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HiFlo-HAPE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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