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

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ClinicalTrials.gov Identifier: NCT01468194
Recruitment Status : Completed
First Posted : November 9, 2011
Last Update Posted : November 9, 2011
Sponsor:
Collaborator:
MVZ für Laboratoriumsmedizin Koblenz
Information provided by (Responsible Party):
Andree Hillebrecht, University of Giessen

October 9, 2011
November 9, 2011
November 9, 2011
July 2011
October 2011   (Final data collection date for primary outcome measure)
change of peripheral oxygen saturation [ Time Frame: immediate after intervention ]
change of peripheral oxygen saturation under different breathing procedures in different altitudes
Same as current
No Changes Posted
  • 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
  • change of cognition [ Time Frame: immediate after intervention ]
    change of ability of cognition (measured by d2-test) under different breathing procedures in different altitudes
Same as current
Not Provided
Not Provided
 
Change in Peripheral Oxygen Saturation by Using Different Breathing Procedures in High Altitude
Not Provided
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.

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.

Interventional
Not Applicable
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Acute Mountain Sickness
  • Other: Breathing procedure 1
    inhalation during one step, exhalation during the next step
  • Other: Breathing procedure 2
    inhalation and exhalation during one step
  • Experimental: Breathing procedure 1
    Walking with breathing procedure "1".
    Intervention: Other: Breathing procedure 1
  • Experimental: Breathing procedure 2
    Walking with breathing procedure "2".
    Intervention: Other: Breathing procedure 2
  • No Intervention: Control group
    Walking without any reglementation of breathing
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
Same as current
November 2011
October 2011   (Final data collection date for primary outcome measure)

Exclusion Criteria:

  • acute clinically significant inter-current diseases
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT01468194
Gi-04-2011
No
Not Provided
Not Provided
Andree Hillebrecht, University of Giessen
University of Giessen
MVZ für Laboratoriumsmedizin Koblenz
Principal Investigator: Gabor Szalay, Dr. med. Trauma surgery - University hospital Giessen
University of Giessen
November 2011

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