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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by AGIR à Dom.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
AGIR à Dom
ClinicalTrials.gov Identifier:
NCT01260428
First received: December 14, 2010
Last updated: February 27, 2012
Last verified: February 2012
  Purpose

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 Intervention
Hypoxia
Device: threshold PEEP

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Arterial Oxygenation During Hypoxia : Effects of an Added Expiratory Resistance

Further study details as provided by AGIR à Dom:

Primary Outcome Measures:
  • SpO2 [ Time Frame: mean over 1 minute ] [ Designated as safety issue: No ]
    after three minutes of PEEP vs spontaneous breathing


Secondary Outcome Measures:
  • peripheral HbO2/DeoxyHb [ Time Frame: 1 min ] [ Designated as safety issue: No ]
    after three minutes of PEEP / PLB vs. spontaneous breathing

  • cardiac output [ Time Frame: mean over 1 min ] [ Designated as safety issue: No ]
    after three min of PEEP vs. spontaneous breathing

  • pattern of breathing (fR, VT, PETCO2) [ Time Frame: 1 min ] [ Designated as safety issue: No ]
    after three min of PEEP vs. spontaneous breathing


Estimated Enrollment: 20
Study Start Date: February 2011
Groups/Cohorts Assigned Interventions
healthy active subjects
with and without high altitude intolerance
Device: threshold PEEP
Various set of pressures : 0, 5, 10 cm H20; pursed lips breathing

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

community sample with mounteneering experience

Criteria

Inclusion Criteria :

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

Exclusion Criteria :

  • cardiac, respiratory, neuromuscular, metabolic pathology
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01260428

Contacts
Contact: Bernard Wuyam, MD, PhD 33 (0)4 76 76 93 03 BWuyam@chu-grenoble.fr

Locations
France
CHU de Grenoble Recruiting
La Tronche, Isere, France, 38000
Contact: BERNARD WUYAM, MD? PhD    (33) 04 76 76 93 03    BWuyam@chu-grenoble.fr   
Contact: hugo nespoulet, Bsc    04 76 76 55 16    HNespoulet@chu-grenoble.fr   
Principal Investigator: Bernard Wuyam, MD, PhD         
Sub-Investigator: Samuel Vergès, PhD         
Sponsors and Collaborators
AGIR à Dom
Investigators
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
  More Information

No publications provided

Responsible Party: AGIR à Dom
ClinicalTrials.gov Identifier: NCT01260428     History of Changes
Other Study ID Numbers: 10-AGIR-2
Study First Received: December 14, 2010
Last Updated: February 27, 2012
Health Authority: AFSAPS : France

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

ClinicalTrials.gov processed this record on September 22, 2014