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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01898858
Other study ID # 5546
Secondary ID
Status Completed
Phase N/A
First received June 21, 2013
Last updated October 14, 2014
Start date September 2013
Est. completion date October 2014

Study information

Verified date October 2014
Source University Hospital, Strasbourg, France
Contact n/a
Is FDA regulated No
Health authority France: Agence Nationale de Sécurité du Médicament et des produits de santé
Study type Observational

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 8
Est. completion date October 2014
Est. primary completion date October 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 40 Years
Eligibility 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 Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Device:
Hypercapnia inhalation (Altitrainer NP 190)
Hypercapnia inhalation using an Altitrainer NP 190
Hypoxia and hypercapnia (Altitrainer NP 190)
Hypoxia and hypercapnia inhalation using an Altitrainer NP 190
Hypoxia inhalation (Altitrainer NP 190)
Hypoxia inhalation using an Altitrainer NP 190

Locations

Country Name City State
France Service de Physiologie et d'Explorations Fonctionnelles, Nouvel Hôpital Civil, Hôpitaux Universitaires de Strasbourg Strasbourg

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary Dyspnea and muscle leg discomfort using a Borg Scale In each conditions at rest and during exercise at the end of the 30th minutes constant load exercise No
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