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

Acute Mountain Sickness Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01468194
• Other study ID #: Gi-04-2011
• Status: Completed
• Phase: N/A
• First received: October 9, 2011
• Last updated: November 8, 2011
• Start date: July 2011
• Est. completion date: November 2011

Study information

• Verified date: November 2011
• Source: University of Giessen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Exclusion Criteria:

• acute clinically significant inter-current diseases

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acute Mountain Sickness
• Altitude Sickness

Intervention

Other:
• Breathing procedure 1
inhalation during one step, exhalation during the next step
• Breathing procedure 2
inhalation and exhalation during one step

Locations

Country	Name	City	State
Germany	University of Giessen	Giessen	Hessen

Sponsors (2)

Lead Sponsor	Collaborator
University of Giessen	MVZ für Laboratoriumsmedizin Koblenz

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change of peripheral oxygen saturation	change of peripheral oxygen saturation under different breathing procedures in different altitudes	immediate after intervention	No
Secondary	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	immediate after intervention	No
Secondary	change of cognition	change of ability of cognition (measured by d2-test) under different breathing procedures in different altitudes	immediate after intervention	No