NCT01468194

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

October 9, 2011

Completed
23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 9, 2011

Completed
Last Updated

November 9, 2011

Status Verified

November 1, 2011

Enrollment Period

3 months

First QC Date

October 9, 2011

Last Update Submit

November 8, 2011

Conditions

Acute Mountain Sickness

Keywords

AMSHAPEhigh altitudeoxygensaturationmountainclimbingbreathing

Outcome Measures

Primary Outcomes (1)

  • change of peripheral oxygen saturation

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

    immediate after intervention

Secondary Outcomes (2)

  • change of breathing parameters

    immediate after intervention

  • change of cognition

    immediate after intervention

Study Arms (3)

Breathing procedure 1

EXPERIMENTAL

Walking with breathing procedure "1".

Other: Breathing procedure 1

Breathing procedure 2

EXPERIMENTAL

Walking with breathing procedure "2".

Other: Breathing procedure 2

Control group

NO INTERVENTION

Walking without any reglementation of breathing

Interventions

Breathing procedure 1OTHER

inhalation during one step, exhalation during the next step

Breathing procedure 1
Breathing procedure 2OTHER

inhalation and exhalation during one step

Breathing procedure 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • acute clinically significant inter-current diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Giessen

Giessen, Hesse, 35394, Germany

Location

MeSH Terms

Conditions

Altitude SicknessRespiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Gabor Szalay, Dr. med.

    Trauma surgery - University hospital Giessen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Akademischer Rat

Study Record Dates

First Submitted

October 9, 2011

First Posted

November 9, 2011

Study Start

July 1, 2011

Primary Completion

October 1, 2011

Study Completion

November 1, 2011

Last Updated

November 9, 2011

Record last verified: 2011-11

Locations

DE(1)