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

Arterial Oxygenation During Hypoxia : Effects of an Added Expiratory Resistance

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.

Study Overview

• Status: Unknown
• Conditions: Hypoxia
• Intervention / Treatment: 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
• Enrollment (Anticipated): 20

Contacts and Locations

• Study Contact: Name: Bernard Wuyam, MD, PhD; Phone Number: 33 (0)4 76 76 93 03; Email: BWuyam@chu-grenoble.fr

Study Locations

• France
  • Isere
    • La Tronche, Isere, France, 38000
      • Recruiting
      • CHU de Grenoble
      • Contact: BERNARD WUYAM, MD? PhD; Phone Number: (33) 04 76 76 93 03; Email: BWuyam@chu-grenoble.fr
      • Contact: hugo nespoulet, Bsc; Phone Number: 04 76 76 55 16; Email: HNespoulet@chu-grenoble.fr
      • Principal Investigator: Bernard Wuyam, MD, PhD
      • Sub-Investigator: Samuel Vergès, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

community sample with mounteneering experience

Description

Inclusion Criteria :

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

Exclusion Criteria :

• cardiac, respiratory, neuromuscular, metabolic pathology

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SpO2	after three minutes of PEEP vs spontaneous breathing	mean over 1 minute

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
peripheral HbO2/DeoxyHb	after three minutes of PEEP / PLB vs. spontaneous breathing	1 min
cardiac output	after three min of PEEP vs. spontaneous breathing	mean over 1 min
pattern of breathing (fR, VT, PETCO2)	after three min of PEEP vs. spontaneous breathing	1 min

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start: February 1, 2011

Study Registration Dates

• First Submitted: December 14, 2010
• First Submitted That Met QC Criteria: December 14, 2010
• First Posted (Estimate): December 15, 2010

Study Record Updates

• Last Update Posted (Estimate): February 28, 2012
• Last Update Submitted That Met QC Criteria: February 27, 2012
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Keywords: hypoxia; PEEP; cardiac output; O2 diffusion and convection; Effects of hypoxia
• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Hypoxia
• Other Study ID Numbers: 10-AGIR-2