NCT01898858

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2013

Geographic Reach
1 country

1 active site

Status
completed

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

June 21, 2013

Completed
21 days until next milestone

First Posted

Study publicly available on registry

July 12, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

October 15, 2014

Status Verified

October 1, 2014

Enrollment Period

1.1 years

First QC Date

June 21, 2013

Last Update Submit

October 14, 2014

Conditions

Pulmonary Vascular Sensibility in HypoxiaHypercapniaHypoxia and Hypercapnia

Outcome Measures

Primary Outcomes (1)

  • Systolic Artery Pulmonary Pressure(sPAP) (echocardiography, Cardiac output (impedancemetry), Cardiorespiratory parameters

    At rest and during exercise for each condition

    at the end of the 30th minutes constant load exercise

Secondary Outcomes (1)

  • Dyspnea and muscle leg discomfort using a Borg Scale

    at the end of the 30th minutes constant load exercise

Study Arms (3)

HYPOXIA

Device: Hypoxia inhalation (Altitrainer NP 190)

HYPERCAPNIA

Device: Hypercapnia inhalation (Altitrainer NP 190)

HYPOXIA + HYPERCAPNIA

Device: Hypoxia and hypercapnia (Altitrainer NP 190)

Interventions

Hypercapnia inhalation (Altitrainer NP 190)DEVICE

Hypercapnia inhalation using an Altitrainer NP 190

HYPERCAPNIA
Hypoxia and hypercapnia (Altitrainer NP 190)DEVICE

Hypoxia and hypercapnia inhalation using an Altitrainer NP 190

HYPOXIA + HYPERCAPNIA
Hypoxia inhalation (Altitrainer NP 190)DEVICE

Hypoxia inhalation using an Altitrainer NP 190

HYPOXIA

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Healthy volunteers

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Physiologie et d'Explorations Fonctionnelles, Nouvel Hôpital Civil, Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France

Location

MeSH Terms

Conditions

HypercapniaHypoxia

Condition Hierarchy (Ancestors)

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

Study Officials

  • PISTEA Cristina, MD

    Hôpitaux Universitaires de Strasbourg

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

June 21, 2013

First Posted

July 12, 2013

Study Start

September 1, 2013

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

October 15, 2014

Record last verified: 2014-10

Locations

FR(1)