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

November 8, 2011 updated by: Andree Hillebrecht, University of Giessen
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.

Study Overview

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

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Hessen
      • Giessen, Hessen, Germany, 35394
        • University of Gießen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Exclusion Criteria:

  • acute clinically significant inter-current diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

  • breathing rate
  • minute ventilation
  • expiratory end-tidal CO2-partial pressure
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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Gabor Szalay, Dr. med., Trauma surgery - University hospital Giessen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

October 9, 2011

First Submitted That Met QC Criteria

November 8, 2011

First Posted (Estimate)

November 9, 2011

Study Record Updates

Last Update Posted (Estimate)

November 9, 2011

Last Update Submitted That Met QC Criteria

November 8, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

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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