Effects of O2 and/or CO2 Inhalation on Rest and Exercise Pulmonary Hemodynamic (H2PAP)

October 14, 2014 updated by: University Hospital, Strasbourg, France

The aim of this study is to describe the pulmonary hemodynamic evolution at rest and during a short constant load exercise in 4 conditions :

  • normoxia
  • hypoxia
  • hypercapnia
  • association hypoxia and hypercapnia

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

8

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Strasbourg, France, 67091
        • Service de Physiologie et d'Explorations Fonctionnelles, Nouvel Hôpital Civil, Hôpitaux universitaires de Strasbourg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Healthy volunteers

Description

Inclusion criteria:

  • healthy male
  • exercise capacity between 100 and 130 % of theorical values

Exclusion criteria:

  • smoker
  • headache
  • impossibility to perform an exercise test
  • no tricuspid regurgitation on the echocardiography

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
HYPOXIA
Device: Hypoxia inhalation (Altitrainer NP 190)
Hypoxia inhalation using an Altitrainer NP 190
HYPERCAPNIA
Device: Hypercapnia inhalation (Altitrainer NP 190)
Hypercapnia inhalation using an Altitrainer NP 190
HYPOXIA + HYPERCAPNIA
Device: Hypoxia and hypercapnia (Altitrainer NP 190)
Hypoxia and hypercapnia inhalation using an Altitrainer NP 190

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Systolic Artery Pulmonary Pressure(sPAP) (echocardiography, Cardiac output (impedancemetry), Cardiorespiratory parameters
Time Frame: at the end of the 30th minutes constant load exercise
At rest and during exercise for each condition
at the end of the 30th minutes constant load exercise

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dyspnea and muscle leg discomfort using a Borg Scale
Time Frame: at the end of the 30th minutes constant load exercise
In each conditions at rest and during exercise
at the end of the 30th minutes constant load exercise

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Investigators

  • Principal Investigator: PISTEA Cristina, MD, Hôpitaux Universitaires de Strasbourg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

June 21, 2013

First Submitted That Met QC Criteria

July 11, 2013

First Posted (Estimate)

July 12, 2013

Study Record Updates

Last Update Posted (Estimate)

October 15, 2014

Last Update Submitted That Met QC Criteria

October 14, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5546

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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