Effects of O2 and/or CO2 Inhalation on Rest and Exercise... | NCT01898858

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

NCT01898858

Sponsor

University Hospital, Strasbourg, France

Status

Completed

Last Update Posted

Oct 15, 2014Estimated

Enrollment

8Actual

Phase

Not provided

Conditions

Pulmonary Vascular Sensibility in Hypoxia
Hypercapnia
Hypoxia and Hypercapnia

Interventions

Hypercapnia inhalation (Altitrainer NP 190)
Hypoxia and hypercapnia (Altitrainer NP 190)
Hypoxia inhalation (Altitrainer NP 190)

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Oct 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2013

Primary Completion Date

Oct 2014Actual

Completion Date

Oct 2014Actual

First Submitted Date

Jun 21, 2013

First Submission Date that Met QC Criteria

Jul 11, 2013

First Posted Date

Jul 12, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 14, 2014

Last Update Posted Date

Oct 15, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

8Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
HYPOXIA			Device: Hypoxia inhalation (Altitrainer NP 190)
HYPERCAPNIA			Device: Hypercapnia inhalation (Altitrainer NP 190)
HYPOXIA + HYPERCAPNIA			Device: Hypoxia and hypercapnia (Altitrainer NP 190)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hypercapnia inhalation (Altitrainer NP 190)	Device	Hypercapnia inhalation using an Altitrainer NP 190	HYPERCAPNIA

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Healthy volunteers

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
PISTEA Cristina, MD	Hôpitaux Universitaires de Strasbourg	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Service de Physiologie et d'Explorations Fonctionnelles, Nouvel Hôpital Civil, Hôpitaux Universitaires de Strasbourg		Strasbourg		67091	France

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D012818	Signs and Symptoms, Respiratory
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms