Controlled Hyperventilation as Prophylaxis for Acute Mountain Sickness

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Brief Title

Controlled Hyperventilation as Prophylaxis for Acute Mountain Sickness

Official Title

Controlled Hyperventilation as Prophylaxis for Acute Mountain Sickness: A Randomized Controlled Trial

Brief Summary

      This study evaluates the safety and efficacy of the voluntary ventilatory response as
      prophylaxis for acute mountain sickness, measured by the Lake Louise Self-Report Score,
      comparing to a group using acetazolamide.
    

Detailed Description

      Rationale: Acute mountain sickness (AMS) is a common condition among people who go to
      altitude and stay at altitude. Acclimatization is the most important mechanism in order to
      reduce the risk of AMS, however, this is not possible or adequate in a large part of the
      cases. Recently, there are indications that adjustment of respiration by means of a voluntary
      increase in the respiratory minute volume can have a similar prophylactic effect. The purpose
      of this study is to measure the effect of the voluntary increase of the minute volume by
      means of controlled hyperventilation as prophylaxis for acute mountain sickness without prior
      acclimatization, with AMS being expressed in the Lake Louise Self-Report Score (LLSRS).

      Objective: To investigate the safety and efficacy of the voluntary increase in minute
      ventilation by means of controlled hyperventilation as prophylaxis for AMS, measured by the
      LLSRS in a randomized controlled trial ascending to 4954m altitude.

      Study design: Prospective randomized controlled trial, safety and efficacy.

      Study population: 30 healthy subjects

      Intervention: The investigational prophylaxis is controlled hyperventilation. Participants in
      the interventional group will be trained to hyperventilate in a controlled fashion doing a
      series of exercises during the 4 days prior to the ascent. They will also be taught in a
      practical way to recognize early clinical signs and symptoms of hypocapnia.

      Main study parameters/endpoints: Safety and efficacy measured by comparing the LLSRS between
      the two groups. Target end-tidal CO2 ( PETCO2) will be measured to objectify adequate
      hyperventilation. Symptoms of hypocapnia due to the (pre-)intervention as well as any adverse
      events will be reported and analysed.
    


Study Type

Interventional


Primary Outcome

Lake Louise Score

Secondary Outcome

 PETCO2

Condition

Altitude Sickness

Intervention

Voluntary ventilatory response

Study Arms / Comparison Groups

 Intervention
Description:  Voluntary increase in respiration

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Behavioral

Estimated Enrollment

30

Start Date

October 2016

Completion Date

May 2017

Primary Completion Date

May 2017

Eligibility Criteria

        Inclusion Criteria:

          -  Living at lower altitude than 900 meters

        Exclusion Criteria:

          -  Cardiac or pulmonary comorbidity

          -  Smoking

          -  Infectious disease during the last 30 days

          -  BMI> 30

          -  Pharmaceutical use as diuretics, corticosteroids, acetazolamide, or anti -inflammatory
             drugs during the 2 weeks prior to the study

          -  A history of high altitude cerebral edema or high altitude pulmonary edema

          -  Cardiovascular risk factors such as a personal history of cardiovascular disease,
             familial history of major adverse cardiovascular events (MACE) at age younger than 45
             yrs, hypercholesterolemia and stroke.
      

Gender

All

Ages

18 Years - 40 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Sebastián Drago, MD, +56992191310, [email protected]

Location Countries

Chile

Location Countries

Chile

Administrative Informations


NCT ID

NCT02972411

Organization ID

HospitalTS


Responsible Party

Principal Investigator

Study Sponsor

Hospital del Trabajador de Santiago


Study Sponsor

Sebastián Drago, MD, Principal Investigator, Hospital del Trabajador Santiago


Verification Date

November 2016