NCT01260428

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 14, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 15, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2011

Completed
Last Updated

February 28, 2012

Status Verified

February 1, 2012

First QC Date

December 14, 2010

Last Update Submit

February 27, 2012

Conditions

Hypoxia

Keywords

hypoxiaO2 diffusion and convectioncardiac outputPEEPEffects of hypoxia

Outcome Measures

Primary Outcomes (1)

  • SpO2

    after three minutes of PEEP vs spontaneous breathing

    mean over 1 minute

Secondary Outcomes (3)

  • peripheral HbO2/DeoxyHb

    1 min

  • cardiac output

    mean over 1 min

  • pattern of breathing (fR, VT, PETCO2)

    1 min

Study Arms (1)

healthy active subjects

with and without high altitude intolerance

Device: threshold PEEP

Interventions

threshold PEEPDEVICE

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

healthy active subjects

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

community sample with mounteneering experience

You may qualify if:

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

You may not qualify if:

  • cardiac, respiratory, neuromuscular, metabolic pathology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Grenoble

La Tronche, Isere, 38000, France

RECRUITING

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Bernard Wuyam, MD, PhD

    University Hospital, Grenoble

    PRINCIPAL INVESTIGATOR

  • Samuel Vergès, PhD

    Institut National de la Santé Et de la Recherche Médicale, France

    STUDY DIRECTOR

  • Hugo NESPOULET, MsC

    Université Joseph Fourier

    STUDY CHAIR

Central Study Contacts

Bernard Wuyam, MD, PhD

CONTACT

33 (0)4 76 76 93 03BWuyam@chu-grenoble.fr

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 14, 2010

First Posted

December 15, 2010

Study Start

February 1, 2011

Last Updated

February 28, 2012

Record last verified: 2012-02

Locations

FR(1)