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

NCT ID: NCT01468194

Last Updated: 2011-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2011-11-30

Brief Summary

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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

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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.

Conditions

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Acute Mountain Sickness

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Breathing procedure 1

Walking with breathing procedure "1".

Group Type EXPERIMENTAL

Breathing procedure 1

Intervention Type OTHER

inhalation during one step, exhalation during the next step

Breathing procedure 2

Walking with breathing procedure "2".

Group Type EXPERIMENTAL

Breathing procedure 2

Intervention Type OTHER

inhalation and exhalation during one step

Control group

Walking without any reglementation of breathing

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Breathing procedure 1

inhalation during one step, exhalation during the next step

Intervention Type OTHER

Breathing procedure 2

inhalation and exhalation during one step

Intervention Type OTHER

Eligibility Criteria

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Exclusion Criteria

* acute clinically significant inter-current diseases
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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MVZ für Laboratoriumsmedizin Koblenz

UNKNOWN

Sponsor Role collaborator

University of Giessen

OTHER

Sponsor Role lead

Responsible Party

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Andree Hillebrecht

Akademischer Rat

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gabor Szalay, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Trauma surgery - University hospital Giessen

Locations

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University of Giessen

Giessen, Hesse, Germany

Site Status

Countries

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Germany

Other Identifiers

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Gi-04-2011

Identifier Type: -

Identifier Source: org_study_id