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

This study is currently recruiting participants.

Verified February 2012 by AGIR à Dom

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

History of Changes

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

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

Additional relevant MeSH terms:

Anoxia
Signs and Symptoms, Respiratory
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013

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