AzTrials
AzTrials

Altitude SicknessNCT02972411

Controlled Hyperventilation as Prophylaxis for Acute Mountain Sickness

A study testing Voluntary ventilatory response and Acetazolamide in people with Altitude Sickness, run by Hospital del Trabajador de Santiago at 1 site in Chile.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for
Altitude Sickness
What is being tested?
Voluntary ventilatory response and Acetazolamide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChile
Study dates
Oct 2016to May 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Living at lower altitude than 900 meters

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Sebastián Drago, MD contact

+56992191310

sebadrago@gmail.com

Juan Campodónico, MD contact

+56981379351

campodonicouc@gmail.com

Chile1 site, 1 recruiting

  • 110 Sports and health center

    Santiago, 8320000

    Mario Sandoval, MD, +56993593944, mariosandoval@110.cl

    Recruiting

Other trials in Chile

About this study

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

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.

Read the 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.

Being tested
Voluntary ventilatory response, Acetazolamide
Medical subject headings
Altitude Sickness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Voluntary ventilatory responseBehavioural

    Training of the subjects for voluntary increase in the respiratory minute ventilation

  • AcetazolamideDrug

    Acetazolamide 125mg. PO every 12 hours since 24 hours before ascent, until 48 hours at high altitude

Study groups in NCT02972411
Study groupRoleWhat they receive
InterventionExperimentalVoluntary increase in respiration
Receives: Behavioral: Voluntary ventilatory response
AcetazolamideActive comparatorAdministration of Acetazolamide 125mg. since 24 hours before ascent and until 48 hours post altitude exposure, and absence of altitude sickness symptoms
Receives: Drug: Acetazolamide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Lake Louise Score

    Intensity and prevalence of Acute Mountain Sickness. During Ascent.

    Measured: Up to 5 months

Secondary outcomes (5)

  1. PETCO2

    Pressure of expired CO2, measured with a monitor in the moutain. During ascent.

    Measured: Up to 5 months

  2. Pulse oxygen saturation

    During ascent.

    Measured: Up to 5 months

  3. Respiratory rate

    During ascent

    Measured: Up to 5 months

  4. Heart rate

    During ascent

    Measured: Up to 5 months

  5. Borg Scale

    During ascent

    Measured: Up to 5 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Nov 2016 (estimated)
  2. Study startOct 2016
  3. Primary completionMay 2017 (estimated)
  4. Study completionMay 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02972411
Sponsor's protocol ID
HospitalTS
Status last verified
Nov 2016
First submitted
25 Oct 2016
Last updated
23 Nov 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

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

    PubMed 23758234

  • 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. No abstract available.

    PubMed 25443751

  • 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.

    PubMed 20591379

  • Richalet JP, Larmignat P, Poitrine E, Letournel M, Canoui-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.

    PubMed 22071330

  • 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.

    PubMed 20335313

  • Vargas M, Osorio J, Jimenez D, Moraga F, Sepulveda M, Del Solar J, Hudson C, Cortes G, Leon 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.

    PubMed 11351468

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

    PubMed 6109857

  • 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. doi: 10.1007/s00421-006-0373-8. Epub 2007 Jan 6.

    PubMed 17206440

  • 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. doi: 10.1183/09031936.06.00015805.

    PubMed 16387950

  • 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. doi: 10.1152/jappl.1986.60.4.1407.

    PubMed 3084449

Questions about this trial

What is this clinical trial studying?

A study testing Voluntary ventilatory response and Acetazolamide in people with Altitude Sickness, run by Hospital del Trabajador de Santiago at 1 site in Chile.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 23 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Sebastián Drago, MD (+56992191310, sebadrago@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Lake Louise Score (time frame: Up to 5 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02972411, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2016.

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