search
Back to results

Change in Peripheral Oxygen Saturation by Using Different Breathing Procedures in High Altitude

Primary Purpose

Acute Mountain Sickness

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Breathing procedure 1
Breathing procedure 2
Sponsored by
University of Giessen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Mountain Sickness focused on measuring AMS, HAPE, high altitude, oxygen, saturation, mountain, climbing, breathing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Exclusion Criteria:

  • acute clinically significant inter-current diseases

Sites / Locations

  • University of Giessen

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Breathing procedure 1

Breathing procedure 2

Control group

Arm Description

Walking with breathing procedure "1".

Walking with breathing procedure "2".

Walking without any reglementation of breathing

Outcomes

Primary Outcome Measures

change of peripheral oxygen saturation
change of peripheral oxygen saturation under different breathing procedures in different altitudes

Secondary Outcome Measures

change of breathing parameters
change of breathing parameters under different breathing procedures in different altitudes breathing rate minute ventilation expiratory end-tidal CO2-partial pressure
change of cognition
change of ability of cognition (measured by d2-test) under different breathing procedures in different altitudes

Full Information

First Posted
October 9, 2011
Last Updated
November 8, 2011
Sponsor
University of Giessen
Collaborators
MVZ für Laboratoriumsmedizin Koblenz
search

1. Study Identification

Unique Protocol Identification Number
NCT01468194
Brief Title
Change in Peripheral Oxygen Saturation by Using Different Breathing Procedures in High Altitude
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Giessen
Collaborators
MVZ für Laboratoriumsmedizin Koblenz

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
In this investigation the researchers explore whether different types of breathing procedures can improve the peripheral oxygen saturation to reduce the risk of becoming a acute mountain sickness or a high altitude pulmonary edema.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Mountain Sickness
Keywords
AMS, HAPE, high altitude, oxygen, saturation, mountain, climbing, breathing

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Breathing procedure 1
Arm Type
Experimental
Arm Description
Walking with breathing procedure "1".
Arm Title
Breathing procedure 2
Arm Type
Experimental
Arm Description
Walking with breathing procedure "2".
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Walking without any reglementation of breathing
Intervention Type
Other
Intervention Name(s)
Breathing procedure 1
Intervention Description
inhalation during one step, exhalation during the next step
Intervention Type
Other
Intervention Name(s)
Breathing procedure 2
Intervention Description
inhalation and exhalation during one step
Primary Outcome Measure Information:
Title
change of peripheral oxygen saturation
Description
change of peripheral oxygen saturation under different breathing procedures in different altitudes
Time Frame
immediate after intervention
Secondary Outcome Measure Information:
Title
change of breathing parameters
Description
change of breathing parameters under different breathing procedures in different altitudes breathing rate minute ventilation expiratory end-tidal CO2-partial pressure
Time Frame
immediate after intervention
Title
change of cognition
Description
change of ability of cognition (measured by d2-test) under different breathing procedures in different altitudes
Time Frame
immediate after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Exclusion Criteria: acute clinically significant inter-current diseases
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gabor Szalay, Dr. med.
Organizational Affiliation
Trauma surgery - University hospital Giessen
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Giessen
City
Giessen
State/Province
Hessen
ZIP/Postal Code
35394
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

Change in Peripheral Oxygen Saturation by Using Different Breathing Procedures in High Altitude

We'll reach out to this number within 24 hrs