Optimization Strategy for the Prevention of AMS by RIPC Combined With Acetazolamide
Condition: Acute Mountain Sickness
MeSH terms: Altitude Sickness
Study type: Interventional
Phase: Phase 4

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Acetazolamide; Doctormate® (twice daily for 6 days); Doctormate® (forth daily for 3 days)
Intervention type(s): Drug; Device; Device
Intervention description(s): Start orally take acetazolamide 125mg twice daily, 2 days before entering the hypoxic chamber. Subjects will enter the hypoxic room at 9am on the third day. At that time, the subject should have taken the drug 5 times.; Start RIPC training twice daily, 6 days before entering the hypoxic chamber. RIPC will be induced by Renqiao Remote Ischemic Conditioning Device (Doctormate®). Each training 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. Subjects will enter the hypoxic room at 9am on the seventh day. At that time, the subject should have finished 13 times of RIPC training.; Start RIPC training forth daily, 3 days before entering the hypoxic chamber. RIPC will be induced by Renqiao Remote Ischemic Conditioning Device (Doctormate®). Each training 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. Subjects will enter the hypoxic room at 9am on the forth day. At that time, the subject should have finished 13 times of RIPC training.
Intervention MeSH terms: Acetazolamide
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Acute Mountain Sickness; Acetazolamide; Remote Ischemic Preconditioning