[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100634191":3},{"organization":4,"outcomesModule":7,"designInfo":31,"detailedDescription":39,"studyPopulation":30,"armGroups":40,"interventions":51,"overallOfficials":57,"centralContacts":62,"locations":68,"responsibleParty":88,"collaborators":30,"id":91,"slug":30,"hasResults":92,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":30,"eligibilityCriteria":96,"healthyVolunteers":92,"sex":97,"minAge":98,"maxAge":30,"enrollmentInfo":99,"targetDuration":30,"studyType":102,"phases":103,"briefSummary":105,"conditions":106,"keywords":108,"overallStatus":71,"whyStopped":30,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},{"fullName":5,"class":6},"Third Military Medical University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":30},[9],{"measure":10,"description":11,"timeFrame":12},"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.",[14,18,22,26],{"measure":15,"description":16,"timeFrame":17},"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.","From date of randomization until the time of first documented treatment failure from any cause, assessed up to about 7 days.",{"measure":19,"description":20,"timeFrame":21},"The Net change in Lung CT Severity Score","Change in Lung CT Severity Score from baseline to Day 3 post-randomization","Day 3",{"measure":23,"description":24,"timeFrame":25},"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.","From enrollment to treatment completion, an average of 3-5 days.",{"measure":27,"description":28,"timeFrame":29},"Incidence of oxygen therapy-related complications","Incidence of oxygen therapy-related complications during hospital stay.","From randomization to discharge, assessed up to about 7 days.",null,{"allocation":32,"interventionModel":33,"interventionModelDescription":30,"primaryPurpose":34,"observationalModel":30,"timePerspective":30,"maskingInfo":35},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":36,"maskingDescription":30,"whoMasked":37},"SINGLE",[38],"OUTCOMES_ASSESSOR","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.",[41,47],{"label":42,"type":43,"description":44,"interventionNames":45},"Intervention Group","EXPERIMENTAL","High-flow Nasal Cannula Oxygen Therapy (HFNC) plus standard medical management",[46],"Device: High-flow Nasal Cannula Oxygen Therapy (HFNC)",{"label":48,"type":49,"description":50,"interventionNames":30},"Control Group","NO_INTERVENTION","Conventional Oxygen Therapy (COT) plus standard medical management",[52],{"type":53,"name":54,"description":55,"armGroupLabels":56,"otherNames":30},"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.",[42],[58],{"name":59,"affiliation":60,"role":61},"Ye Fan, Dr.","Department of Respiratory Disease, Xinqiao Hospital, Third Military Medical University, 83 Xinqiao Zhengjie, Shapingba District, ChongQing 400000, China","PRINCIPAL_INVESTIGATOR",[63],{"name":64,"role":65,"phone":66,"phoneExt":30,"email":67},"Yiding Li, Dr.","CONTACT","+86 13101377031","fygan@163.com",[69],{"facility":70,"status":71,"city":72,"state":73,"zip":74,"country":75,"countryCode":76,"cosmosGeoPoint":77,"geoPoint":82,"contacts":83},"NO.953 Hospital","RECRUITING","Xigazê","Tibet","857000","China","CN",{"type":78,"coordinates":79},"Point",[80,81],88.88333,29.25,{"lat":81,"lon":80},[84],{"name":85,"role":65,"phone":86,"phoneExt":30,"email":87},"Sai Wang","18108923665","wangsai0204@163.com",{"type":61,"investigatorFullName":89,"investigatorTitle":90,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"Ye Fan","Principal Investigator","100634191",false,"NCT07536477","High-flow Nasal Cannula Oxygen Therapy Versus Conventional Oxygen Therapy in High-altitude Pulmonary Edema","High-flow Nasal Cannula Oxygen Therapy Versus Conventional Oxygen Therapy in Patients With High-altitude Pulmonary Edema: A Prospective Randomized Controlled Study","Inclusion Criteria:\n\n1. Aged 18 years or older;\n2. Onset of symptoms related to HAPE (including dyspnea at rest, cough, or exercise intolerance) within 7 days of ascending to high altitude (≥2500m);\n3. Diagnosis of HAPE according to the STAR data reporting guidelines, requiring at least two symptoms (dyspnea at rest, cough, weakness\u002Fdecreased exercise performance, or chest tightness\u002Fcongestion) and two clinical signs (rales or wheezing in at least one lung field, central cyanosis, tachypnea, or tachycardia);\n4. Radiographic evidence of pulmonary edema on chest X-ray or CT;\n5. Refusal or inability to undergo immediate descent at the time of presentation;\n6. Capability and willingness to provide written informed consent.\n\nExclusion criteria:\n\n1. Known or clinically confirmed pregnancy;\n2. Requirement for emergency intubation (as assessed by the treating clinician) due to cardiac\u002Frespiratory arrest, hemodynamic instability, airway compromise, severe hypoxia, or impaired consciousness, etc;\n3. 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.);\n4. Glasgow Coma Scale (GCS) score ≤ 12;\n5. PaCO₂ \\> 55 mmHg;\n6. Presence of high-altitude cerebral edema;\n7. Receipt of any respiratory support therapy (other than conventional oxygen therapy) prior to admission;\n8. Presence of any contraindication to conventional or nasal oxygen therapy;\n9. 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;\n10. Current participation in other clinical trials;\n11. Refusal to sign the informed consent form.","ALL","18 Years",{"count":100,"type":101},200,"ESTIMATED","INTERVENTIONAL",[104],"NA","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).",[107],"High-altitude Pulmonary Edema",[109],"HAPE","2026-04-28",{"date":112,"type":113},"2026-05-04","ACTUAL",{"date":115,"type":113},"2026-04-25",{"date":117,"type":101},"2029-04-22",{"name":5,"class":6},1]