Multicenter Randomized Double-Blind Control Trial Evaluating the Utility of Continuous Positive Airway Pressure (CPAP) in the Treatment of High Altitude Pulmonary Edema (HAPE)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Time to resolution of HAPE
研究概览
简要总结
The primary objective is to evaluate the efficacy of continuous positive pressure on resolution of high-altitude pulmonary edema vs high flow oxygen. The secondary objective is to derive an incidence of high-altitude pulmonary edema based on the elevation and timing from which the subject arrives. Additionally, in a convenience sample of the base study population, an ultrasound evaluation for the presence of B lines in the lungs will be conducted after 2 hours.
详细描述
Multicenter, double-blinded, randomized control trial. Enrollment is based on presentation to one of the treating facilities with clinical signs and symptoms of high-altitude pulmonary edema with a recent arrival at high altitude, an oxygen saturation below 85%, and radiographic evidence of noncardiogenic pulmonary edema. A total of 264 patients will be randomized 1:1 across 2 study arms: a CPAP mask set to 15cm H2O and an altered CPAP mask in which the pressure valve has been modified to deliver no positive pressure. All patients will be treated with 30mg nifedipine XR. Except for the application of positive pressure, all other interventions are performed in the context of everyday clinical practice, and thus will be equivalent for participants in both arms. Patients will be evaluated every 30 minutes for their ability to maintain an oxygen saturation of 92% with a normal respiratory rate and no signs of increased work of breathing on 2 liters of nasal cannula oxygen for a total of up to a maximum treatment length of 2 hours. The primary efficacy endpoint will be assessed every 30 minutes for 2 hours.
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
- Double (Participant, Care Provider)
盲法说明
Standard CPAP systems and control CPAP systems that provide high flow oxygen without PEEP
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female, age 18 years or greater
- •Oxygen saturation below 85%
- •Recent arrival to high altitude
- •Dyspnea and cough
- •Xray revealing non-cardiogenic pulmonary edema
排除标准
- •Pregnancy
- •Age below 18
- •Patients with respiratory failure requiring intubation
- •Patients with altered mental status
- •Patients with impaired decision-making capacity
- •Patients with a history of congestive heart failure, CAD, COPD, asthma, known current pneumonia
- •Extreme facial hair precluding application of CPAP
研究组 & 干预措施
Experimental: CPAP
Participants will be treated with CPAP. All patients will be treated with nifedipine unless there is a contraindication like hypotension and bradycardia.
干预措施: CPAP mask system (Device)
Experimental: CPAP
Participants will be treated with CPAP. All patients will be treated with nifedipine unless there is a contraindication like hypotension and bradycardia.
干预措施: Nifedipine 30 MG (Drug)
Control: High flow oxygen
Participants will be treated with an altered CPAP mask that will deliver high flow oxygen. All patients will be treated with nifedipine unless there is a contraindication like hypotension and bradycardia.
干预措施: Nifedipine 30 MG (Drug)
Control: High flow oxygen
Participants will be treated with an altered CPAP mask that will deliver high flow oxygen. All patients will be treated with nifedipine unless there is a contraindication like hypotension and bradycardia.
干预措施: CPAP mask system without PEEP (Device)
结局指标
主要结局
Time to resolution of HAPE
时间窗: 2 hours
The amount of time it took to maintain oxygen saturation over 92% on 2L NC oxygen
次要结局
- Presence or absence of ultrasound detectable B lines(2 hours)
- Incidence of HAPE by native altitude and reported sleeping altitude(2 hours)
- Characterization of time at altitude to development of HAPE(2 hours)
研究者
Todd Bolotin
Principal Investigator
CommonSpirit Health