Non-Invasive Positive Pressure Ventilation Management of High Altitude Pulmonary Edema
试验速览
- 阶段
- 不适用
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Oxygen saturation
研究概览
简要总结
Trial of Non-Invasive Positive Pressure Ventilation Management of High Altitude Pulmonary Edema
详细描述
Patients in the Everest area will assessed for evidence of acute HAPE. Subjects will be randomized and assigned to standard care options or treatment with Non-Invasive Positive Pressure Ventilation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
No masking will be done, as the CPAP device will be visible to both participants and investigators
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults (age 18-80)
- •Travel through Pheriche, Nepal
- •Diagnosis of HAPE by symptoms, vital signs, and lung ultrasound
排除标准
- •History of chronic respiratory conditions (asthma, COPD, ILD)
- •Concomitant pneumonia or aspiration, cardiomyopathy, congestive heart failure
- •Kidney disease
- •Neurologic disorder
- •Cognitive disorder
- •Temporary altered mental status
- •Use of phosphodiesterase inhibitors or nifedipine prior to diagnosis of HAPE
- •Age under 18 or over 80
- •Pregnancy
研究组 & 干预措施
Standard of Care Treatment
Continuous supplemental oxygen and nifedipine 30mg will be administered to patients.
干预措施: Nifedipine (Drug)
Standard of Care Treatment
Continuous supplemental oxygen and nifedipine 30mg will be administered to patients.
干预措施: supplemental oxygen (Other)
Non-Invasive Positive Pressure Ventilation Management
CPAP at 10mmHg with supplemental oxygen, as well as nifedipine 30mg will be administered to patients.
干预措施: Non-Invasive Positive Pressure Ventilation (Device)
Non-Invasive Positive Pressure Ventilation Management
CPAP at 10mmHg with supplemental oxygen, as well as nifedipine 30mg will be administered to patients.
干预措施: Nifedipine (Drug)
结局指标
主要结局
Oxygen saturation
时间窗: Up to 4 hours
Displayed on pulse oximeter
次要结局
- Ultrasonographic assessment of pulmonary edema(Up to 4 hours)
- Subjective rating of dyspnea(Up to 4 hours)
研究者
N. Stuart Harris MD MFA
Chief, Division of Wilderness Medicine, Principal Investigator, Clinical Innstructor
Massachusetts General Hospital