Optimization Strategy for the Prevention of Acute Mountain Sickness by Remote Ischemic Preconditioning Combined With Acetazolamide
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 252
- 试验地点
- 1
- 主要终点
- The incidence of acute mountain sickness.
研究概览
简要总结
The primary objective of the study will be to determine whether rapid remote limb ischemic preconditioning (RIPC) combined with acetazolamide can further reduce the incidence of acute mountain sickness (AMS) during the 6-hour hypoxic chamber.
详细描述
The current measures to prevent acute mountain sickness (AMS) mainly include drug prevention and non-drug prevention. Acetazolamide is a drug approved by the U.S. FDA for the prevention and treatment of AMS. Remote limb ischemic preconditioning (RIPC) can also reduce the incidence of AMS as a non-durg method, with a strategy of 2 times/day training for 1 week reducing the incidence of AMS in 6 hours from 40% to 30%. The objective of this study is to determine whether rapid RIPC training combined with acetazolamide can further reduce the incidence of AMS. In this study, subjects will be divided into 5 groups: medicine group (acetazolamid 125mg bid, 2 days before entering the hypoxic room), RIPC group (RIPC training twice daily, 6 days before entering the hypoxic room), rapid RIPC group (RIPC training forth daily, 3 days before entering the hypoxic room), combined group (rapid RIPC training plus acetazolamide) and controlled group. RIPC training, completed by Renqiao Remote Ischemic Conditioning Device (Doctormate®), will be comprised of 5 cycles of bilateral upper limb ischemia and reperfusion, which will be induced by 2 cuffs placed around the upper arms respectively and inflated to 200mmHg for 5 minutes followed by 5 minutes of reperfusion by cuff deflation. After the intervention, subjects will be exposed to 4500m altitude in a normobaric hypoxic chamber for 6 hours. The incidence of AMS and other data will be compared between groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- None
盲法说明
Due to the nature of the procedure, it was not possible to blind subjects to the intervention of medicine or RIPC.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •People who live in plain areas all year round and have not been to an altitude of 1500 meters or more in the past 30 days;
- •Sign the informed consent form voluntarily.
排除标准
- •Chronic physical or mental diseases, including hypertension, diabetes, coronary heart disease, cerebrovascular disease, chronic obstructive pulmonary disease, migraine, anxiety, depression, insomnia, etc.;
- •The female is pregnant or in the period of preparing for pregnancy or breast-feeding;
- •Have a history of smoking;
- •Have a history of thrombosis in the upper limbs;
- •Severe damage to local soft tissues of upper limbs, fractures, etc.;
- •Allergic to sulfa;
- •Are taking one or more drugs;
- •Past laboratory tests suggest hypokalemia, hyponatremia, or liver and kidney damage;
- •Patients unsuitable for enrollment in the clinical trial according to investigators decision making.
研究组 & 干预措施
Medicine Group
Start orally take Acetazolamide 2 days before entering the hypoxic room.
干预措施: Acetazolamide (Drug)
RIPC Group
Start RIPC training twice daily, 6 days before entering the hypoxic room.
干预措施: Doctormate® (twice daily for 6 days) (Device)
Rapid RIPC Group
Start RIPC training forth daily, 3 days before entering the hypoxic room.
干预措施: Doctormate® (forth daily for 3 days) (Device)
Combined Group
Medicine + Rapid RIPC
干预措施: Acetazolamide (Drug)
Combined Group
Medicine + Rapid RIPC
干预措施: Doctormate® (forth daily for 3 days) (Device)
结局指标
主要结局
The incidence of acute mountain sickness.
时间窗: 6 hours after entering the hypoxic room.
The diagnosis of acute mountain sickness is based on '2018 Lake Louise Acute Mountain Sickness Score' , 'Acute Mountain Sickness-Cerebral Scores',etc. All subjects should finish the questionnaires to evaluate the total incidence.
Fingre pulse oximetry of the subjects.
时间窗: 6 hours after entering the hypoxic room.
Fingre pulse oximetry using pocket pulse oximeters will be noted.
The severity of acute mountain sickness.
时间窗: 6 hours after entering the hypoxic room.
The diagnosis of acute mountain sickness is based on '2018 Lake Louise Acute Mountain Sickness Score' , 'Acute Mountain Sickness-Cerebral Scores',etc. All subjects should finish the questionnaires to evaluate the total incidence.
次要结局
- Blood pressure of the subjects.(6 hours after entering the hypoxic room.)
- Respiratory rate of the subjects.(6 hours after entering the hypoxic room.)
- Heart rate of the subjects.(6 hours after entering the hypoxic room.)
研究者
Ji Xunming,MD,PhD
VP, Professor
Capital Medical University