High-altitude Pulmonary EdemaNCT07910357
High-flow Nasal Cannula Oxygen Therapy Versus Conventional Oxygen Therapy in Children High-altitude Pulmonary Edema
A study testing High-flow Nasal Cannula Oxygen Therapy (HFNC) in people with High-altitude Pulmonary Edema, run by Ye Fan at 1 site in China.
Trial 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 children with High-Altitude Pulmonary Edema (HAPE). Read more about this study
- Who is it for?
- Ages 0 to 14 years
- Conditions the study is for
- High-altitude Pulmonary Edema
- What is being tested?
- High-flow Nasal Cannula Oxygen Therapy (HFNC)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2027to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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: 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) according to the STAR data reporting guidelines; plus imaging evidence of pulmonary edema.
- Aged from 0 to 14 years old, without gender restriction.
- Written informed consent obtained from the subject's legal guardian(s).
- Refusal or inability to undergo immediate descent at the time of presentation.
Who cannot join
- Severe respiratory failure requiring immediate endotracheal intubation upon hospital admission, including severe hypoxemia, acidosis and/or respiratory distress, upper-airway obstruction, inability to manage airway secretions, recurrent apnea, altered mental status, etc.
- Pre-term infants with corrected gestational age ≤36 weeks.
- Receipt of non-conventional respiratory support (e.g., HFNC, CPAP) for more than 2 hours within 24 hours prior to randomization, or planned use of other non-invasive respiratory support modalities.
- Emergent conditions requiring invasive/surgical intervention, including untreated pneumothorax / pneumomediastinum, massive pleural effusion, high-altitude cerebral edema.
- Pulmonary edema or hypoxemia attributable to other underlying diseases, such as congenital heart disease, chronic obstructive pulmonary disease, asthma, bronchopulmonary dysplasia, pulmonary infection, and others.
- Status post tracheostomy.
Show all 13Show fewer
- Conditions precluding tolerance to HFNC, including unrepaired cleft palate, severe nasal malformation, recent craniofacial / nasal surgery.
- Chronic home non-invasive ventilation use.
- Pre-hospital hyperbaric oxygen chamber treatment prior to enrollment.
- Presence of any serious medical conditions or clinically significant laboratory abnormalities that, in the investigator's judgment, may compromise subject safety or ability to complete the study.
- Patients with signed Do Not Intubate (DNI) order or other limitations on the intensity of critical care treatment.
- Participation in another drug or medical device clinical trial within 3 months, or prior enrollment in other interventional studies of the same category.
- Refusal to sign the informed consent form.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ye Fan, Dr contact
China1 site
General Hospital of Tibet Military Command
Lhasa, Tibet
Xueyue Wang, 18875026393, wangxueyue0331@163.com
About this study
Official title: High-flow Nasal Cannula Oxygen Therapy Versus Conventional Oxygen Therapy in Children 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 children with High-Altitude Pulmonary Edema (HAPE).
Read the 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 children with HAPE.
- Conditions
- High-altitude Pulmonary Edema
- Being tested
- High-flow Nasal Cannula Oxygen Therapy (HFNC)
- Keywords
- HAPE
- Medical subject headings
- Altitude Sickness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | High-flow Nasal Cannula Oxygen Therapy (HFNC) plus standard medical management Receives: Device: High-flow Nasal Cannula Oxygen Therapy (HFNC) |
| Control Group | No intervention | Conventional Oxygen Therapy (COT) plus standard medical management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From date of randomization until the time of first documented treatment failure from any cause, or until hospital discharge, assessed up to 5 days
Secondary outcomes (4)
Time to weaning off supplemental oxygen
Hours from randomization to successful weaning to room air
Measured: 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
Measured: 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.
Measured: 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
Measured: From randomization to discharge, assessed up to about 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study start1 Jan 2027 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for High-altitude Pulmonary EdemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ye Fan
- Sponsor type
- University, hospital or other
- Collaborators
- The General Hospital of Tibet Military Command
- Responsible party
- Sponsor-investigator, Ye Fan, Third Military Medical University
- Investigators
- Ye Fan, Dr, Principal investigator, Third Military Medical University / The General Hospital of Tibet Military Command
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07910357
- Sponsor's protocol ID
- HiFlo-PedHAPE
- Status last verified
- Oct 2026
- First submitted
- 26 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ramnarayan P, Richards-Belle A, Drikite L, Saull M, Orzechowska I, Darnell R, Sadique Z, Lester J, Morris KP, Tume LN, Davis PJ, Peters MJ, Feltbower RG, Grieve R, Thomas K, Mouncey PR, Harrison DA, Rowan KM; FIRST-ABC Step-Up RCT Investigators and the Paediatric Critical Care Society Study Group. Effect of High-Flow Nasal Cannula Therapy vs Continuous Positive Airway Pressure Therapy on Liberation From Respiratory Support in Acutely Ill Children Admitted to Pediatric Critical Care Units: A Randomized Clinical Trial. JAMA. 2022 Jul 12;328(2):162-172. doi: 10.1001/jama.2022.9615.
PubMed 35707984Helms J, Catoire P, Abensur Vuillaume L, Bannelier H, Douillet D, Dupuis C, Federici L, Jezequel M, Jozwiak M, Kuteifan K, Labro G, Latournerie G, Michelet F, Monnet X, Persichini R, Polge F, Savary D, Vromant A, Adda I, Hraiech S. Oxygen therapy in acute hypoxemic respiratory failure: guidelines from the SRLF-SFMU consensus conference. Ann Intensive Care. 2024 Sep 5;14(1):140. doi: 10.1186/s13613-024-01367-2.
PubMed 39235690Liptzin DR, Abman SH, Giesenhagen A, Ivy DD. An Approach to Children with Pulmonary Edema at High Altitude. High Alt Med Biol. 2018 Mar;19(1):91-98. doi: 10.1089/ham.2017.0096. Epub 2018 Feb 22.
PubMed 29470103Zafren K, Reeves JT, Schoene R. Treatment of high-altitude pulmonary edema by bed rest and supplemental oxygen. Wilderness Environ Med. 1996 May;7(2):127-32. doi: 10.1580/1080-6032(1996)007[0127:tohape]2.3.co;2.
PubMed 11990106Imray C, Wright A, Subudhi A, Roach R. Acute mountain sickness: pathophysiology, prevention, and treatment. Prog Cardiovasc Dis. 2010 May-Jun;52(6):467-84. doi: 10.1016/j.pcad.2010.02.003.
PubMed 20417340Kelly TD, Meier M, Weinman JP, Ivy D, Brinton JT, Liptzin DR. High-Altitude Pulmonary Edema in Colorado Children: A Cross-Sectional Survey and Retrospective Review. High Alt Med Biol. 2022 Jun;23(2):119-124. doi: 10.1089/ham.2021.0121. Epub 2022 Apr 5.
PubMed 35384735Ucros S, Aparicio C, Castro-Rodriguez JA, Ivy D. High altitude pulmonary edema in children: A systematic review. Pediatr Pulmonol. 2023 Apr;58(4):1059-1067. doi: 10.1002/ppul.26294. Epub 2022 Dec 29.
PubMed 36562650
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-flow Nasal Cannula Oxygen Therapy Versus Conventional Oxygen Therapy in Children With High-altitude Pulmonary Edema: A Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07910357
- Acronym / sponsor ID
- HiFlo-PedHAPE
- Conditions
- High-altitude Pulmonary Edema
- Keywords
- HAPE
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Ye FanUniversity, hospital or other
- Collaborators
- The General Hospital of Tibet Military Command
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 2 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 children with HAPE.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Device: High-flow Nasal Cannula Oxygen Therapy (HFNC)High-flow Nasal Cannula Oxygen Therapy (HFNC) plus standard medical management |
| Control Group | No intervention | –Conventional Oxygen Therapy (COT) plus standard medical management |
Who may qualify
- Ages
- 0 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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: 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) according to the STAR data reporting guidelines; plus imaging evidence of pulmonary edema.
- Aged from 0 to 14 years old, without gender restriction.
- Written informed consent obtained from the subject's legal guardian(s).
- Refusal or inability to undergo immediate descent at the time of presentation.
Key exclusion criteria (13 listed)
- Severe respiratory failure requiring immediate endotracheal intubation upon hospital admission, including severe hypoxemia, acidosis and/or respiratory distress, upper-airway obstruction, inability to manage airway secretions, recurrent apnea, altered mental status, etc.
- Pre-term infants with corrected gestational age ≤36 weeks.
- Receipt of non-conventional respiratory support (e.g., HFNC, CPAP) for more than 2 hours within 24 hours prior to randomization, or planned use of other non-invasive respiratory support modalities.
- Emergent conditions requiring invasive/surgical intervention, including untreated pneumothorax / pneumomediastinum, massive pleural effusion, high-altitude cerebral edema.
- Pulmonary edema or hypoxemia attributable to other underlying diseases, such as congenital heart disease, chronic obstructive pulmonary disease, asthma, bronchopulmonary dysplasia, pulmonary infection, and others.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Intervention Group |
Primary outcome
Proportion of treatment failure
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
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.
4 secondary outcomes
Time to weaning off supplemental oxygen
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
Time frame: Day 3 post-randomization
Evolvement of SpO2
Time frame: 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 5 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Background: PubMed 35707984Ramnarayan P, Richards-Belle A, Drikite L, Saull M, Orzechowska I, Darnell R, Sadique Z, Lester J, Morris KP, Tume LN, Davis PJ, Peters MJ, Feltbower RG, Grieve R, Thomas K, Mouncey PR, Harrison DA, Rowan KM; FIRST-ABC Step-Up RCT Investigators and the Paediatric Critical Care Society Study Group. Effect of High-Flow Nasal Cannula Therapy vs Continuous Positive Airway Pressure Therapy on Liberation From Respiratory Support in Acutely Ill Children Admitted to Pediatric Critical Care Units: A Randomized Clinical Trial. JAMA. 2022 Jul 12;328(2):162-172. doi: 10.1001/jama.2022.9615.
- Background: PubMed 39235690Helms J, Catoire P, Abensur Vuillaume L, Bannelier H, Douillet D, Dupuis C, Federici L, Jezequel M, Jozwiak M, Kuteifan K, Labro G, Latournerie G, Michelet F, Monnet X, Persichini R, Polge F, Savary D, Vromant A, Adda I, Hraiech S. Oxygen therapy in acute hypoxemic respiratory failure: guidelines from the SRLF-SFMU consensus conference. Ann Intensive Care. 2024 Sep 5;14(1):140. doi: 10.1186/s13613-024-01367-2.
- Background: PubMed 29470103Liptzin DR, Abman SH, Giesenhagen A, Ivy DD. An Approach to Children with Pulmonary Edema at High Altitude. High Alt Med Biol. 2018 Mar;19(1):91-98. doi: 10.1089/ham.2017.0096. Epub 2018 Feb 22.
- Background: PubMed 11990106Zafren K, Reeves JT, Schoene R. Treatment of high-altitude pulmonary edema by bed rest and supplemental oxygen. Wilderness Environ Med. 1996 May;7(2):127-32. doi: 10.1580/1080-6032(1996)007[0127:tohape]2.3.co;2.
- Background: PubMed 20417340Imray C, Wright A, Subudhi A, Roach R. Acute mountain sickness: pathophysiology, prevention, and treatment. Prog Cardiovasc Dis. 2010 May-Jun;52(6):467-84. doi: 10.1016/j.pcad.2010.02.003.
- Background: PubMed 35384735Kelly TD, Meier M, Weinman JP, Ivy D, Brinton JT, Liptzin DR. High-Altitude Pulmonary Edema in Colorado Children: A Cross-Sectional Survey and Retrospective Review. High Alt Med Biol. 2022 Jun;23(2):119-124. doi: 10.1089/ham.2021.0121. Epub 2022 Apr 5.
- Background: PubMed 36562650Ucros S, Aparicio C, Castro-Rodriguez JA, Ivy D. High altitude pulmonary edema in children: A systematic review. Pediatr Pulmonol. 2023 Apr;58(4):1059-1067. doi: 10.1002/ppul.26294. Epub 2022 Dec 29.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ye Fan, Dr contact
Ye Fan, Dr principal investigator
Third Military Medical University / The General Hospital of Tibet Military Command
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-flow Nasal Cannula Oxygen Therapy (HFNC) in people with High-altitude Pulmonary Edema, run by Ye Fan at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xianjin Bi, Dr (+86 13212517496, bixianjin@foxmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of treatment failure (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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07910357, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.