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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01260428
Other study ID # 10-AGIR-2
Secondary ID
Status Recruiting
Phase N/A
First received December 14, 2010
Last updated February 27, 2012
Start date February 2011

Study information

Verified date February 2012
Source AGIR à Dom
Contact Bernard Wuyam, MD, PhD
Phone 33 (0)4 76 76 93 03
Email BWuyam@chu-grenoble.fr
Is FDA regulated No
Health authority AFSAPS : France
Study type Observational

Clinical Trial Summary

Altitude tolerance correlates with the level of oxygenation achieved. The aim of the present study is to investigate whether increased expiratory pressure within the thorax is able to improve oxygenation during hypoxic hypoxia.


Description:

Two types of procedures will be tested in a random order, interspaced by resting periods : threshold PEEP set at 5,10 and 15 cm of water and pursed leap breathing.

Subjects will be tested at rest, and during light exercise (30% of sea level predicted VO2max).

FiO2 will be set at 12.5% (4000 m). fc, VE, PETCO2, TA, ECG, cardiac output, and tissular oxygenation will be monitored.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria :

- active (> 2 hrs/week physical activity)

- adult

- non smoking volunteers

Exclusion Criteria :

- cardiac, respiratory, neuromuscular, metabolic pathology

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Device:
threshold PEEP
Various set of pressures : 0, 5, 10 cm H20; pursed lips breathing

Locations

Country Name City State
France CHU de Grenoble La Tronche Isere

Sponsors (1)

Lead Sponsor Collaborator
AGIR à Dom

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary SpO2 after three minutes of PEEP vs spontaneous breathing mean over 1 minute No
Secondary peripheral HbO2/DeoxyHb after three minutes of PEEP / PLB vs. spontaneous breathing 1 min No
Secondary cardiac output after three min of PEEP vs. spontaneous breathing mean over 1 min No
Secondary pattern of breathing (fR, VT, PETCO2) after three min of PEEP vs. spontaneous breathing 1 min No
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