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

Study Description

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.

Study Design

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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

Drug Information available for: Acetazolamide

Genetic and Rare Diseases Information Center resources: Acute Mountain Sickness

U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

PETCO2 [ Time Frame: Up to 5 months ]
Pressure of expired CO2, measured with a monitor in the moutain. During ascent.
Pulse oxygen saturation [ Time Frame: Up to 5 months ]
During ascent.
Respiratory rate [ Time Frame: Up to 5 months ]
During ascent
Heart rate [ Time Frame: Up to 5 months ]
During ascent
Borg Scale [ Time Frame: Up to 5 months ]
During ascent

Other Outcome Measures:

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

Eligibility Criteria

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.

Contacts and Locations

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

More Information

Publications:

Bärtsch P, Swenson ER. Clinical practice: Acute high-altitude illnesses. N Engl J Med. 2013 Jun 13;368(24):2294-302. doi: 10.1056/NEJMcp1214870. Review.

Buijze GA, Hopman MT. Controlled hyperventilation after training may accelerate altitude acclimatization. Wilderness Environ Med. 2014 Dec;25(4):484-6. doi: 10.1016/j.wem.2014.04.009. Epub 2014 Oct 14.

Luks AM, McIntosh SE, Grissom CK, Auerbach PS, Rodway GW, Schoene RB, Zafren K, Hackett PH; Wilderness Medical Society. Wilderness Medical Society consensus guidelines for the prevention and treatment of acute altitude illness. Wilderness Environ Med. 2010 Jun;21(2):146-55. doi: 10.1016/j.wem.2010.03.002. Epub 2010 Mar 10. Erratum in: Wilderness Environ Med. 2010 Dec;21(4):386.

Richalet JP, Larmignat P, Poitrine E, Letournel M, Canouï-Poitrine F. Physiological risk factors for severe high-altitude illness: a prospective cohort study. Am J Respir Crit Care Med. 2012 Jan 15;185(2):192-8. doi: 10.1164/rccm.201108-1396OC. Epub 2011 Oct 27.

Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials. Ann Intern Med. 2010 Jun 1;152(11):726-32. doi: 10.7326/0003-4819-152-11-201006010-00232. Epub 2010 Mar 24.

Vargas M, Osorio J, Jiménez D, Moraga F, Sepúlveda M, Del Solar J, Hudson C, Cortés G, León A. [Acute mountain sickness at 3500 and 4250 m. A study of symptom, incidence and severity]. Rev Med Chil. 2001 Feb;129(2):166-72. Spanish.

Acetazolamide in control of acute mountain sickness. Lancet. 1981 Jan 24;1(8213):180-3.

Bernardi L, Passino C, Spadacini G, Bonfichi M, Arcaini L, Malcovati L, Bandinelli G, Schneider A, Keyl C, Feil P, Greene RE, Bernasconi C. Reduced hypoxic ventilatory response with preserved blood oxygenation in yoga trainees and Himalayan Buddhist monks at altitude: evidence of a different adaptive strategy? Eur J Appl Physiol. 2007 Mar;99(5):511-8. Epub 2007 Jan 6.

Bernardi L, Schneider A, Pomidori L, Paolucci E, Cogo A. Hypoxic ventilatory response in successful extreme altitude climbers. Eur Respir J. 2006 Jan;27(1):165-71.

Moore LG, Harrison GL, McCullough RE, McCullough RG, Micco AJ, Tucker A, Weil JV, Reeves JT. Low acute hypoxic ventilatory response and hypoxic depression in acute altitude sickness. J Appl Physiol (1985). 1986 Apr;60(4):1407-12.

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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

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