An interventional study of High-flow Nasal Cannula Oxygen Therapy (HFNC) in High-altitude Pulmonary Edema, sponsored by Ye Fan. Not yet recruiting at 1 site in China. Open to participants aged 0 Years to 14 Years. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by Ye Fan · Not applicable, Interventional, and Treatment
This study aims to evaluate whether High-flow Nasal Cannula Oxygen Therapy (HFNC) provides superior respiratory support compared to Conventional Oxygen Therapy (COT) in children with High-Altitude Pulmonary Edema (HAPE).
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 children with HAPE.
216 studies on the registry are indexed under Altitude Sickness; 46 are open to participants now.
This study's planned enrollment of 116 is above the median of 34 across 178 interventional studies indexed under Altitude Sickness.
Browse Altitude Sickness studies →This is the only study on the registry with Ye Fan as lead sponsor.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
High-flow Nasal Cannula Oxygen Therapy (HFNC) plus standard medical management
Device: High-flow Nasal Cannula Oxygen Therapy (HFNC)
Conventional Oxygen Therapy (COT) plus standard medical management
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.
Proportion of treatment failure
Treatment failure: defined as the proportion of children who still cannot maintain target oxygen saturation or present with severe respiratory distress after standardized optimization of current oxygen-therapy parameters to the maximum recommended intensity, requiring escalation to non-invasive positive-pressure ventilation or invasive mechanical ventilation, or manifesting significant intolerance to the assigned oxygen therapy.
Time frame: From date of randomization until the time of first documented treatment failure from any cause, or until hospital discharge, assessed up to 5 days
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
Net change in imaging Pulmonary Edema Score
Change in imaging Pulmonary Edema Score from baseline to Day 3 post-randomization
Time frame: Day 3 post-randomization
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
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 5 days
Plan to share: No
Start is estimated for Jan 2027; primary completion for Dec 2029, 35 months later.
Of 76 non-industry interventional studies with no phase under Altitude Sickness, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 21. This study's planned 35 months is above that.
Counting every sponsor, half of 76 studies reached it within 9 months; a quarter within 3 and three quarters within 21.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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