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Controlled Hyperventilation as Prophylaxis for Acute Mountain Sickness

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ClinicalTrials.gov Identifier: NCT02972411
Recruitment Status : Unknown
Verified November 2016 by Sebastián Drago Pérez, Hospital del Trabajador de Santiago.
Recruitment status was:  Recruiting
First Posted : November 23, 2016
Last Update Posted : November 23, 2016
Sponsor:
Information provided by (Responsible Party):
Sebastián Drago Pérez, Hospital del Trabajador de Santiago

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.

Condition or disease Intervention/treatment Phase
Altitude Sickness Behavioral: Voluntary ventilatory response Drug: Acetazolamide Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Controlled Hyperventilation as Prophylaxis for Acute Mountain Sickness: A Randomized Controlled Trial
Study Start Date : October 2016
Estimated Primary Completion Date : May 2017
Estimated Study Completion Date : May 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention
Voluntary increase in respiration
Behavioral: Voluntary ventilatory response
Training of the subjects for voluntary increase in the respiratory minute ventilation

Active Comparator: Acetazolamide
Administration of Acetazolamide 125mg. since 24 hours before ascent and until 48 hours post altitude exposure, and absence of altitude sickness symptoms
Drug: Acetazolamide
Acetazolamide 125mg. PO every 12 hours since 24 hours before ascent, until 48 hours at high altitude




Primary Outcome Measures :
  1. Lake Louise Score [ Time Frame: Up to 5 months ]
    Intensity and prevalence of Acute Mountain Sickness. During Ascent.


Secondary Outcome Measures :
  1. PETCO2 [ Time Frame: Up to 5 months ]
    Pressure of expired CO2, measured with a monitor in the moutain. During ascent.

  2. Pulse oxygen saturation [ Time Frame: Up to 5 months ]
    During ascent.

  3. Respiratory rate [ Time Frame: Up to 5 months ]
    During ascent

  4. Heart rate [ Time Frame: Up to 5 months ]
    During ascent

  5. Borg Scale [ Time Frame: Up to 5 months ]
    During ascent


Other Outcome Measures:
  1. Training satisfactory. PETCO2 below 20 mmHg [ Time Frame: Up to 6 months ]
    After ascent.

  2. Training satisfactory after Ascent. PETCO2 below 20mmHg [ Time Frame: Up to 6 months ]
    After ascent.

  3. hypoxic ventilatory response [ Time Frame: Up to 6 months ]
    Before ascent



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02972411


Contacts
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Contact: Sebastián Drago, MD +56992191310 sebadrago@gmail.com
Contact: Juan Campodónico, MD +56981379351 campodonicouc@gmail.com

Locations
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Chile
110 Sports and health center Recruiting
Santiago, Chile, 8320000
Contact: Mario Sandoval, MD    +56993593944    mariosandoval@110.cl   
Sponsors and Collaborators
Hospital del Trabajador de Santiago
Investigators
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Principal Investigator: Sebastián Drago, MD Hospital del Trabajador Santiago

Publications:

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Responsible Party: Sebastián Drago Pérez, Orthopaedic Surgeon, Hospital del Trabajador de Santiago
ClinicalTrials.gov Identifier: NCT02972411    
Other Study ID Numbers: HospitalTS
First Posted: November 23, 2016    Key Record Dates
Last Update Posted: November 23, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Altitude Sickness
Hyperventilation
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Acetazolamide
Anticonvulsants
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Diuretics
Natriuretic Agents
Physiological Effects of Drugs