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

NCT07536477 | Recruiting DMC

• 1 other identifier: HiFlo-HAPE
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

High-altitude Pulmonary Edema

Keywords

HAPE

Outcome Measures

Primary Outcomes (1)

• Time to weaning off supplemental oxygen

  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 Outcomes (4)

• Proportion of treatment failure

  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

  Day 3

• Evolvement of SpO2

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

• Incidence of oxygen therapy-related complications

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

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

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

Control Group

NO INTERVENTION

Conventional Oxygen Therapy (COT) plus standard medical management

Interventions

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.

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Refusal or inability to undergo immediate descent at the time of presentation;
• Capability and willingness to provide written informed consent.

You may not qualify if:

• 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;
• PaCO₂ \> 55 mmHg;
• Presence of high-altitude cerebral edema;
• Receipt of any respiratory support therapy (other than conventional oxygen therapy) prior to admission;
• Presence of any contraindication to conventional or nasal oxygen therapy;
• 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;
• Current participation in other clinical trials;
• Refusal to sign the informed consent form.

Sponsors & Collaborators

• Third Military Medical University: lead

Study Sites (1)

NO.953 Hospital

Xigazê, Tibet, 857000, China

RECRUITING

Related Publications (7)

• 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.

  PMID: 34874419 BACKGROUND

• 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.

  PMID: 29596018 BACKGROUND

• 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.

  PMID: 29903755 BACKGROUND

• 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.

  PMID: 30888444 BACKGROUND

• 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.

  PMID: 39657981 BACKGROUND

• 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.

  PMID: 25981908 BACKGROUND

• 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.

  PMID: 37833187 BACKGROUND

MeSH Terms

Conditions

Altitude Sickness

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Ye Fan, Dr.

  Department of Respiratory Disease, Xinqiao Hospital, Third Military Medical University, 83 Xinqiao Zhengjie, Shapingba District, ChongQing 400000, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yiding Li, Dr.

CONTACT

+86 13101377031; fygan@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 3, 2026
• First Posted: April 17, 2026
• Study Start: April 25, 2026
• Primary Completion (Estimated): April 22, 2029
• Study Completion (Estimated): April 22, 2029
• Last Updated: May 4, 2026

Record last verified: 2026-04

Locations

CN (1)