High-flow Nasal Cannula Oxygen Therapy Versus Conventional Oxygen Therapy in Patients With High-altitude Pulmonary Edema: A Prospective Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 208
- 试验地点
- 1
- 主要终点
- Proportion of treatment failure
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Intervention Group
High-flow Nasal Cannula Oxygen Therapy (HFNC) plus standard medical management
干预措施: High-flow Nasal Cannula Oxygen Therapy (HFNC) (Device)
Control Group
Conventional Oxygen Therapy (COT) plus standard medical management
结局指标
主要结局
Proportion of treatment failure
时间窗: From date of randomization until the time of first documented treatment failure from any cause, assessed up to about 7 days.
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.
次要结局
- 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.)
- Time to weaning off supplemental oxygen(From date of randomization to oxygen therapy completion (oxygen weaning), an average of 3-5 days.)
研究者
Ye Fan
Principal Investigator
Third Military Medical University