Acclimatization Mechanisms During Ascent to 7500m - Tabular View

Tracking Information

First Received Date ^ICMJE

January 15, 2008

Last Updated Date

January 26, 2008

Start Date ^ICMJE

March 2005

Primary Completion Date

December 2005 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

acute mountain sickness [ Time Frame: during ascent ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00603122 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

mountaineering success, oxygen saturation, breathing pattern [ Time Frame: during ascent ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Acclimatization Mechanisms During Ascent to 7500m

Official Title ^ICMJE

Acclimatization Mechanisms During Ascent to 7500m. Effects of Ascent Protocol on Acute Mountain Sickness and Cardiorespiratory Physiology

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.

Detailed Description

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Open Label, Active Control, Parallel Assignment

Condition ^ICMJE

Acute Mountain Sickness

Intervention ^ICMJE

Behavioral: ascent protocol

Study Arms / Comparison Groups

Experimental: fast ascent
Active Comparator: slow ascent

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 ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 2005

Primary Completion Date

December 2005 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00603122

Responsible Party

Konrad E. Bloch, University Hospital Zurich

Study ID Numbers ^ICMJE

EK-1189, SNSF 3200B0-108300

Study Sponsor ^ICMJE

University of Zurich

Collaborators ^ICMJE

Swiss National Science Foundation

Investigators ^ICMJE

Principal Investigator:

Konrad E Bloch, MD

Pulmonary Division, University Hospital of Zurich, Zurich, Switzerland

Information Provided By

University of Zurich

Verification Date

January 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP