Effects of Expiratory Pressure on Arterial Oxygenation During Hypoxia (hypex)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01260428
Recruitment Status : Unknown
Verified February 2012 by AGIR à Dom.
Recruitment status was:  Recruiting
First Posted : December 15, 2010
Last Update Posted : February 28, 2012
Information provided by (Responsible Party):
AGIR à Dom

Brief 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.

Condition or disease Intervention/treatment
Hypoxia Device: threshold PEEP

Detailed 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.

Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Arterial Oxygenation During Hypoxia : Effects of an Added Expiratory Resistance
Study Start Date : February 2011

Group/Cohort Intervention/treatment
healthy active subjects
with and without high altitude intolerance
Device: threshold PEEP
Various set of pressures : 0, 5, 10 cm H20; pursed lips breathing

Primary Outcome Measures :
  1. SpO2 [ Time Frame: mean over 1 minute ]
    after three minutes of PEEP vs spontaneous breathing

Secondary Outcome Measures :
  1. peripheral HbO2/DeoxyHb [ Time Frame: 1 min ]
    after three minutes of PEEP / PLB vs. spontaneous breathing

  2. cardiac output [ Time Frame: mean over 1 min ]
    after three min of PEEP vs. spontaneous breathing

  3. pattern of breathing (fR, VT, PETCO2) [ Time Frame: 1 min ]
    after three min of PEEP vs. spontaneous breathing

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
community sample with mounteneering experience

Inclusion Criteria :

  • active (> 2 hrs/week physical activity)
  • adult
  • non smoking volunteers

Exclusion Criteria :

  • cardiac, respiratory, neuromuscular, metabolic pathology

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01260428

Contact: Bernard Wuyam, MD, PhD 33 (0)4 76 76 93 03

CHU de Grenoble Recruiting
La Tronche, Isere, France, 38000
Contact: BERNARD WUYAM, MD? PhD    (33) 04 76 76 93 03   
Contact: hugo nespoulet, Bsc    04 76 76 55 16   
Principal Investigator: Bernard Wuyam, MD, PhD         
Sub-Investigator: Samuel Vergès, PhD         
Sponsors and Collaborators
AGIR à Dom
Principal Investigator: Bernard Wuyam, MD, PhD University Hospital, Grenoble
Study Director: Samuel Vergès, PhD Institut National de la Santé Et de la Recherche Médicale, France
Study Chair: Hugo NESPOULET, MsC Université Joseph Fourier

Responsible Party: AGIR à Dom Identifier: NCT01260428     History of Changes
Other Study ID Numbers: 10-AGIR-2
First Posted: December 15, 2010    Key Record Dates
Last Update Posted: February 28, 2012
Last Verified: February 2012

Keywords provided by AGIR à Dom:
O2 diffusion and convection
cardiac output
Effects of hypoxia

Additional relevant MeSH terms:
Signs and Symptoms, Respiratory
Signs and Symptoms