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

Official title

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

Overview

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).

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.

Interventions

• 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.

Primary outcome measures

• Time to weaning off supplemental oxygen [Time frame: From date of randomization to oxygen therapy completion (oxygen weaning), an average of 3-5 days.]

Secondary outcome measures (4)

• 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.]
• The Net change in Lung CT Severity Score [Time frame: Day 3]
• 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 7 days.]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

China · 1 center

• NO.953 Hospital — Xigazê

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 v PMID 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. PMID 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. PMID 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: 10.10 PMID 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 PMID 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 PMID 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. PMID 37833187

Identifiers

NCT: NCT07536477 · HiFlo-HAPE

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗