- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01468194
Change in Peripheral Oxygen Saturation by Using Different Breathing Procedures in High Altitude
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Acute mountain sickness (AMS) is a pathological effect of high altitude on humans caused by acute exposure to low partial pressure of oxygen at high altitude. It commonly occurs above 2500 meters of altitude. AMS appears as a collection of nonspecific symptoms acquired at high altitude or in low air pressure resembling a case of "flu, carbon monoxide poisoning, or a hangover".
It is caused by a drop in pressure and lowering partial pressure of oxygen during increasing altitude. The direct consequence of those changes is a hypoxic pulmonary vasoconstriction (Euler-Lijestrand-mechanism). In addition a rise in pulmonary blood pressure (Hypertonia) can occur so that there is a higher risk of developing a high altitude pulmonary edema (HAPE).
In this investigation the investigators are exploring whether different types of breathing procedures can improve the peripheral oxygen saturation. We are comparing breathing with no regulation with two different procedures of hyperventilation during trekking in different altitudes. Procedure 1 (hyperventilation 1) describes inhalation during one step and exhalation during the next step. Procedure 2 (hyperventilation 2) describes inhalation and exhalation during one step.
The effect of the different breathing procedures can be quantified measuring the peripheral oxygen saturation. In addition the investigators are comparing the breathing rate and the minute ventilation as well as the expiratory end-tidal CO2-partial pressure of the three different breathing procedures.
Furthermore, the investigators are examining the ability to concentrate in order to quantify the effect of AMS on organ functions.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Hessen
-
Giessen, Hessen, Germany, 35394
- University of Gießen
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Exclusion Criteria:
- acute clinically significant inter-current diseases
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Breathing procedure 1
Walking with breathing procedure "1".
|
inhalation during one step, exhalation during the next step
|
Experimental: Breathing procedure 2
Walking with breathing procedure "2".
|
inhalation and exhalation during one step
|
No Intervention: Control group
Walking without any reglementation of breathing
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change of peripheral oxygen saturation
Time Frame: immediate after intervention
|
change of peripheral oxygen saturation under different breathing procedures in different altitudes
|
immediate after intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change of breathing parameters
Time Frame: immediate after intervention
|
change of breathing parameters under different breathing procedures in different altitudes
|
immediate after intervention
|
change of cognition
Time Frame: immediate after intervention
|
change of ability of cognition (measured by d2-test) under different breathing procedures in different altitudes
|
immediate after intervention
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Gabor Szalay, Dr. med., Trauma surgery - University hospital Giessen
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Gi-04-2011
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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