Back to resultsAcclimatization Mechanisms During Ascent to 7500m
Primary Purpose
Acute Mountain Sickness
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ascent protocol
Sponsored by
About this trial
This is an interventional prevention trial for Acute Mountain Sickness focused on measuring altitude illness, hypoxia
Eligibility Criteria
Inclusion Criteria:
- Healthy, physically fit subject
- Mountaineering experience
Exclusion Criteria:
- Any type of cardiac or respiratory disease
- Regular intake of any medication
- History of high altitude pulmonary oedema
- Severe acute mountain sickness at altitudes below 3500m or high altitude cerebral oedema.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
fast ascent
slow ascent
Outcomes
Primary Outcome Measures
acute mountain sickness
Secondary Outcome Measures
mountaineering success, oxygen saturation, breathing pattern
Full Information
NCT ID
NCT00603122
First Posted
January 15, 2008
Last Updated
May 18, 2014
Sponsor
University of Zurich
Collaborators
Swiss National Science Foundation
1. Study Identification
Unique Protocol Identification Number
NCT00603122
Brief Title
Acclimatization Mechanisms During Ascent to 7500m
Official Title
Acclimatization Mechanisms During Ascent to 7500m. Effects of Ascent Protocol on Acute Mountain Sickness and Cardiorespiratory Physiology
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
December 2005 (Actual)
Study Completion Date
December 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Zurich
Collaborators
Swiss National Science Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The trial evaluates the role of ascent protocol on acute mountain sickness and cardio-respiratory physiology during an ascent to Muztagh Ata (7546m). Two groups of mountaineers ascend with different acclimatization time to the summit. The prevalence and severity of symptoms of acute mountain sickness are evaluated along with physiologic variables.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Mountain Sickness
Keywords
altitude illness, hypoxia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
fast ascent
Arm Title
2
Arm Type
Active Comparator
Arm Description
slow ascent
Intervention Type
Behavioral
Intervention Name(s)
ascent protocol
Intervention Description
ascent protocol for the two groups has different acclimatization time
Primary Outcome Measure Information:
Title
acute mountain sickness
Time Frame
during ascent
Secondary Outcome Measure Information:
Title
mountaineering success, oxygen saturation, breathing pattern
Time Frame
during ascent
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy, physically fit subject
Mountaineering experience
Exclusion Criteria:
Any type of cardiac or respiratory disease
Regular intake of any medication
History of high altitude pulmonary oedema
Severe acute mountain sickness at altitudes below 3500m or high altitude cerebral oedema.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Konrad E Bloch, MD
Organizational Affiliation
Pulmonary Division, University Hospital of Zurich, Zurich, Switzerland
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
20442435
Citation
Bloch KE, Latshang TD, Turk AJ, Hess T, Hefti U, Merz TM, Bosch MM, Barthelmes D, Hefti JP, Maggiorini M, Schoch OD. Nocturnal periodic breathing during acclimatization at very high altitude at Mount Muztagh Ata (7,546 m). Am J Respir Crit Care Med. 2010 Aug 15;182(4):562-8. doi: 10.1164/rccm.200911-1694OC. Epub 2010 May 4.
Results Reference
background
PubMed Identifier
23365990
Citation
Garde A, Giraldo BF, Jane R, Latshang TD, Turk AJ, Hess T, Bosch MM, Barthelmes D, Hefti JP, Maggiorini M, Hefti U, Merz TM, Schoch OD, Bloch KE. Periodic breathing during ascent to extreme altitude quantified by spectral analysis of the respiratory volume signal. Annu Int Conf IEEE Eng Med Biol Soc. 2012;2012:707-10. doi: 10.1109/EMBC.2012.6346029.
Results Reference
background
PubMed Identifier
22093058
Citation
Latshang TD, Turk AJ, Hess T, Schoch OD, Bosch MM, Barthelmes D, Merz TM, Hefti U, Hefti JP, Maggiorini M, Bloch KE. Acclimatization improves submaximal exercise economy at 5533 m. Scand J Med Sci Sports. 2013 Aug;23(4):458-67. doi: 10.1111/j.1600-0838.2011.01403.x. Epub 2011 Nov 3.
Results Reference
background
PubMed Identifier
19326598
Citation
Bloch KE, Turk AJ, Maggiorini M, Hess T, Merz T, Bosch MM, Barthelmes D, Hefti U, Pichler J, Senn O, Schoch OD. Effect of ascent protocol on acute mountain sickness and success at Muztagh Ata, 7546 m. High Alt Med Biol. 2009 Spring;10(1):25-32. doi: 10.1089/ham.2008.1043.
Results Reference
result
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Acclimatization Mechanisms During Ascent to 7500m
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