ClinicalTrials.gg
Status unknownNCT01260428hypexUpdated Feb 28, 2012

Effects of Expiratory Pressure on Arterial Oxygenation During Hypoxia

An observational study in Hypoxia, sponsored by AGIR à Dom. Status unknown at 1 site in France. Open to female participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-02-28.

Sponsored by AGIR à Dom · Observational

The sponsor has not verified this record recently (last verified Feb 2012), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
20
Ages
18 Years to 65 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Hypoxia

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Keywords

  • hypoxia
  • O2 diffusion and convection
  • cardiac output
  • PEEP
  • Effects of hypoxia
03

In context

Hypoxia

1,246 studies on the registry are indexed under Hypoxia; 239 are open to participants now.

This study's planned enrollment of 20 is below the median of 68 across 338 observational studies indexed under Hypoxia.

Browse Hypoxia studies →

Lead sponsor

AGIR à Dom is the lead sponsor of 17 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

community sample with mounteneering experience

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria :

  • cardiac, respiratory, neuromuscular, metabolic pathology
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
20 participants (estimated)

Groups and cohorts

  • healthy active subjects

    with and without high altitude intolerance

    Device: threshold PEEP

Interventions

  • Devicethreshold PEEP

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

06

What researchers measure

Primary outcomes

  1. SpO2

    after three minutes of PEEP vs spontaneous breathing

    Time frame: mean over 1 minute

Secondary outcomes

  1. peripheral HbO2/DeoxyHb

    after three minutes of PEEP / PLB vs. spontaneous breathing

    Time frame: 1 min

  2. cardiac output

    after three min of PEEP vs. spontaneous breathing

    Time frame: mean over 1 min

  3. pattern of breathing (fR, VT, PETCO2)

    after three min of PEEP vs. spontaneous breathing

    Time frame: 1 min

07

Study locations

1 of 1 sites recruiting
  • CHU de Grenoble
    La Tronche, Isere 38000, France
    • BERNARD WUYAM, MD? PhD · Contact · BWuyam@chu-grenoble.fr · (33) 04 76 76 93 03
    • hugo nespoulet, Bsc · Contact · HNespoulet@chu-grenoble.fr · 04 76 76 55 16
    • Bernard Wuyam, MD, PhD · Principal investigator
    • Samuel Vergès, PhD · Sub investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 28, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01260428
Lead sponsor
AGIR à Dom
Responsible party
Sponsor
First posted
Dec 15, 2010
Start date
Feb 2011
Last update
Feb 28, 2012

Study contacts

Bernard Wuyam, MD, PhD
Contact
BWuyam@chu-grenoble.fr
33 (0)4 76 76 93 03
Bernard Wuyam, MD, PhD
principal investigator · University Hospital, Grenoble
Samuel Vergès, PhD
study director · Institut National de la Santé Et de la Recherche Médicale, France
Hugo NESPOULET, MsC
study chair · Université Joseph Fourier

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2012. You cannot join it, but the record below documents what was studied.

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