Pulmonary Vascular Sensibility in HypoxiaH2PAPNCT01898858
Effects of O2 and/or CO2 Inhalation on Rest and Exercise Pulmonary Hemodynamic
An observational study of Pulmonary Vascular Sensibility in Hypoxia and Hypercapnia, run by University Hospital, Strasbourg, France at 1 site in France.
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 Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Vascular Sensibility in Hypoxia, Hypercapnia, Hypoxia and Hypercapnia
- What is being tested?
- Hypercapnia inhalation (Altitrainer NP 190), Hypoxia and hypercapnia (Altitrainer NP 190) and Hypoxia inhalation (Altitrainer NP 190)
- Type of treatment
- Medical device
- How many people
- 8 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2013to Oct 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: Healthy volunteers
Who may be able to join
- healthy male
- exercise capacity between 100 and 130 % of theorical values
Who cannot join
- smoker
- headache
- impossibility to perform an exercise test
- no tricuspid regurgitation on the echocardiography
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Physiologie et d'Explorations Fonctionnelles, Nouvel Hôpital Civil, Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
About this study
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
- Being tested
- Hypercapnia inhalation (Altitrainer NP 190), Hypoxia and hypercapnia (Altitrainer NP 190), Hypoxia inhalation (Altitrainer NP 190)
- Medical subject headings
- Hypercapnia, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypercapnia inhalation (Altitrainer NP 190)Device
Hypercapnia inhalation using an Altitrainer NP 190
Hypoxia and hypercapnia (Altitrainer NP 190)Device
Hypoxia and hypercapnia inhalation using an Altitrainer NP 190
Hypoxia inhalation (Altitrainer NP 190)Device
Hypoxia inhalation using an Altitrainer NP 190
| Study group | Role | What they receive |
|---|---|---|
| HYPOXIA | Not described Receives: Device: Hypoxia inhalation (Altitrainer NP 190) | |
| HYPERCAPNIA | Not described Receives: Device: Hypercapnia inhalation (Altitrainer NP 190) | |
| HYPOXIA + HYPERCAPNIA | Not described Receives: Device: Hypoxia and hypercapnia (Altitrainer NP 190) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic Artery Pulmonary Pressure(sPAP) (echocardiography, Cardiac output (impedancemetry), Cardiorespiratory parameters
At rest and during exercise for each condition
Measured: at the end of the 30th minutes constant load exercise
Secondary outcomes (1)
Dyspnea and muscle leg discomfort using a Borg Scale
In each conditions at rest and during exercise
Measured: at the end of the 30th minutes constant load exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2013 (estimated)
- Study startSep 2013
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Vascular Sensibility in HypoxiaStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- PISTEA Cristina, MD, Principal investigator, Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01898858
- Sponsor's protocol ID
- 5546
- Acronym
- H2PAP
- Status last verified
- Oct 2014
- First submitted
- 21 Jun 2013
- Last updated
- 15 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of O2 and/or CO2 Inhalation on Rest and Exercise Pulmonary Hemodynamic
- ClinicalTrials.gov ID
- NCT01898858
- Acronym / sponsor ID
- H2PAP / 5546
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 12 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HYPOXIA | – | Device: Hypoxia inhalation (Altitrainer NP 190) |
| HYPERCAPNIA | – | Device: Hypercapnia inhalation (Altitrainer NP 190) |
| HYPOXIA + HYPERCAPNIA | – | Device: Hypoxia and hypercapnia (Altitrainer NP 190) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy volunteers
Key inclusion criteria (2 listed)
- healthy male
- exercise capacity between 100 and 130 % of theorical values
Key exclusion criteria (4 listed)
- smoker
- headache
- impossibility to perform an exercise test
- no tricuspid regurgitation on the echocardiography
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypercapnia inhalation (Altitrainer NP 190)Hypercapnia inhalation using an Altitrainer NP 190 | Device | HYPERCAPNIA |
| Hypoxia and hypercapnia (Altitrainer NP 190)Hypoxia and hypercapnia inhalation using an Altitrainer NP 190 | Device | HYPOXIA + HYPERCAPNIA |
| Hypoxia inhalation (Altitrainer NP 190)Hypoxia inhalation using an Altitrainer NP 190 | Device | HYPOXIA |
Primary outcome
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
1 secondary outcome
Dyspnea and muscle leg discomfort using a Borg Scale
Time frame: at the end of the 30th minutes constant load exercise
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2014.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
PISTEA Cristina, MD principal investigator
Hôpitaux Universitaires de Strasbourg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Vascular Sensibility in Hypoxia and Hypercapnia, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic Artery Pulmonary Pressure(sPAP) (echocardiography, Cardiac output (impedancemetry), Cardiorespiratory parameters (time frame: at the end of the 30th minutes constant load exercise). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2014.