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RecruitingNCT07536477Updated Aug 11, 2026

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

An interventional study of High-flow Nasal Cannula Oxygen Therapy (HFNC) in High-altitude Pulmonary Edema, sponsored by Third Military Medical University. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-11.

Sponsored by Third Military Medical University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Apr 2026; still recruiting 6 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
208
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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).

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 patients with HAPE.

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Conditions studied

  • High-altitude Pulmonary Edema

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Keywords

  • HAPE
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In context

Altitude Sickness

216 studies on the registry are indexed under Altitude Sickness; 46 are open to participants now.

This study's planned enrollment of 208 is above the median of 34 across 178 interventional studies indexed under Altitude Sickness.

Browse Altitude Sickness studies →

Lead sponsor

Third Military Medical University is the lead sponsor of 83 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 .

Exclusion criteria

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, (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 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 form.
Terms in these criteria, in plain language(3)

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.

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.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
208 participants (estimated)

Study arms

  • Experimental
    Intervention Group

    High-flow Nasal Cannula Oxygen Therapy (HFNC) plus standard medical management

    Device: High-flow Nasal Cannula Oxygen Therapy (HFNC)

  • No intervention
    Control Group

    Conventional Oxygen Therapy (COT) plus standard medical management

Interventions

  • DeviceHigh-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.

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What researchers measure

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.

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Study locations

1 of 1 sites recruiting
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References and documents

Publications

  • Ospina-Tascon GA, Calderon-Tapia LE, Garcia AF, Zarama V, Gomez-Alvarez F, Alvarez-Saa T, Pardo-Otalvaro S, Bautista-Rincon DF, Vargas MP, Aldana-Diaz JL, Marulanda A, Gutierrez A, Varon J, Gomez M, Ochoa ME, Escobar E, Umana M, Diez J, Tobon GJ, Albornoz LL, Celemin Florez CA, Ruiz GO, Caceres EL, Reyes LF, Damiani LP, Cavalcanti AB; HiFLo-Covid Investigators. Effect of High-Flow Oxygen Therapy vs Conventional Oxygen Therapy on Invasive Mechanical Ventilation and Clinical Recovery in Patients With Severe COVID-19: A Randomized Clinical Trial. JAMA. 2021 Dec 7;326(21):2161-2171. doi: 10.1001/jama.2021.20714. PubMed 34874419 ↗
  • Brodmann Maeder M, Brugger H, Pun M, Strapazzon G, Dal Cappello T, Maggiorini M, Hackett P, Bartsch P, Swenson ER, Zafren K. The STAR Data Reporting Guidelines for Clinical High Altitude Research. High Alt Med Biol. 2018 Mar;19(1):7-14. doi: 10.1089/ham.2017.0160. Epub 2018 Feb 9. PubMed 29596018 ↗
  • Warren MA, Zhao Z, Koyama T, Bastarache JA, Shaver CM, Semler MW, Rice TW, Matthay MA, Calfee CS, Ware LB. Severity scoring of lung oedema on the chest radiograph is associated with clinical outcomes in ARDS. Thorax. 2018 Sep;73(9):840-846. doi: 10.1136/thoraxjnl-2017-211280. Epub 2018 Jun 14. PubMed 29903755 ↗
  • Rochwerg B, Granton D, Wang DX, Helviz Y, Einav S, Frat JP, Mekontso-Dessap A, Schreiber A, Azoulay E, Mercat A, Demoule A, Lemiale V, Pesenti A, Riviello ED, Mauri T, Mancebo J, Brochard L, Burns K. High flow nasal cannula compared with conventional oxygen therapy for acute hypoxemic respiratory failure: a systematic review and meta-analysis. Intensive Care Med. 2019 May;45(5):563-572. doi: 10.1007/s00134-019-05590-5. Epub 2019 Mar 19. PubMed 30888444 ↗
  • RENOVATE Investigators and the BRICNet Authors; Maia IS, Kawano-Dourado L, Tramujas L, de Oliveira NE, Souza RN, Signorini DF, Pincelli MP, Zandonai CL, Blasius RT, Freires F, Ferreira VM, Romano MLP, Miura MC, de Censo CM, Caser EB, Silva B, Santos Bonomo DC, Arraes JA, de Alencar Filho MS, Alvares Horta JG, Oliveira DC, Boschi E, Costa RL, Westphal GA, Ramos J, Lacerda FH, Filho CRH, Pinheiro BV, de Andrade Neumamm LB, Guimaraes Junior MRR, de Souza DT, Ferreira JC, Ohe LN, Schettini DA, Thompson MM, de Oliveira MCF, Veiga VC, Negrelli KL, Santos RHN, Damiani L, Gurgel RM, Gomes SPC, Lima LM, Miranda TA, Laranjeira LN, de Barros E Silva PGM, Machado FR, Fitzgerald M, Bosse A, Marion J, Carvalho CRR, Brochard L, Lewis RJ, Biasi Cavalcanti A. High-Flow Nasal Oxygen vs Noninvasive Ventilation in Patients With Acute Respiratory Failure: The RENOVATE Randomized Clinical Trial. JAMA. 2025 Mar 11;333(10):875-890. doi: 10.1001/jama.2024.26244. PubMed 39657981 ↗
  • Frat JP, Thille AW, Mercat A, Girault C, Ragot S, Perbet S, Prat G, Boulain T, Morawiec E, Cottereau A, Devaquet J, Nseir S, Razazi K, Mira JP, Argaud L, Chakarian JC, Ricard JD, Wittebole X, Chevalier S, Herbland A, Fartoukh M, Constantin JM, Tonnelier JM, Pierrot M, Mathonnet A, Beduneau G, Deletage-Metreau C, Richard JC, Brochard L, Robert R; FLORALI Study Group; REVA Network. High-flow oxygen through nasal cannula in acute hypoxemic respiratory failure. N Engl J Med. 2015 Jun 4;372(23):2185-96. doi: 10.1056/NEJMoa1503326. Epub 2015 May 17. PubMed 25981908 ↗
  • Luks AM, Beidleman BA, Freer L, Grissom CK, Keyes LE, McIntosh SE, Rodway GW, Schoene RB, Zafren K, Hackett PH. Wilderness Medical Society Clinical Practice Guidelines for the Prevention, Diagnosis, and Treatment of Acute Altitude Illness: 2024 Update. Wilderness Environ Med. 2024 Mar;35(1_suppl):2S-19S. doi: 10.1016/j.wem.2023.05.013. Epub 2023 Dec 27. PubMed 37833187 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07536477
Lead sponsor
Third Military Medical University
Responsible party
Ye Fan (Principal Investigator, Third Military Medical University) — Principal investigator
First posted
Apr 17, 2026
Start date
Apr 25, 2026
Primary completion
Apr 22, 2029 (estimated)
Completion
Apr 22, 2029 (estimated)
Last update
Aug 11, 2026

Study contacts

Yiding Li, Dr.
Contact
fygan@163.com
+86 13101377031
Ye Fan, Dr.
principal investigator · Department of Respiratory Disease, Xinqiao Hospital, Third Military Medical University, 83 Xinqiao Zhengjie, Shapingba District, ChongQing 400000, China

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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