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

Hypercapnia Clinical Trial

— H2PAP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01898858
• Other study ID #: 5546
• 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

• Hypercapnia
• Hypoxia and Hypercapnia
• Pulmonary Vascular Sensibility in Hypoxia

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