HypoxiahypexNCT01260428
Effects of Expiratory Pressure on Arterial Oxygenation During Hypoxia
An observational study of Hypoxia, run by AGIR à Dom at 1 site in France.
Trial summary
Altitude tolerance correlates with the level of oxygenation achieved. The aim of the present study is to investigate whether increased expiratory pressure within the thorax is able to improve oxygenation during hypoxic hypoxia. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hypoxia
- What is being tested?
- threshold PEEP
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2011to not given
- 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 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: community sample with mounteneering experience
Who may be able to join
- active (> 2 hrs/week physical activity)
- adult
- non smoking volunteers
Who cannot join
- cardiac, respiratory, neuromuscular, metabolic pathology
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU de Grenoble
La Tronche, Isere, 38000
BERNARD WUYAM, MD? PhD, (33) 04 76 76 93 03, BWuyam@chu-grenoble.fr
hugo nespoulet, Bsc, 04 76 76 55 16, HNespoulet@chu-grenoble.fr
About this study
Official title: Arterial Oxygenation During Hypoxia : Effects of an Added Expiratory Resistance
Altitude tolerance correlates with the level of oxygenation achieved. The aim of the present study is to investigate whether increased expiratory pressure within the thorax is able to improve oxygenation during hypoxic hypoxia.
Read the detailed description
Two types of procedures will be tested in a random order, interspaced by resting periods : threshold PEEP set at 5,10 and 15 cm of water and pursed leap breathing.
Subjects will be tested at rest, and during light exercise (30% of sea level predicted VO2max).
FiO2 will be set at 12.5% (4000 m). fc, VE, PETCO2, TA, ECG, cardiac output, and tissular oxygenation will be monitored.
- Conditions
- Hypoxia
- Being tested
- threshold PEEP
- Keywords
- hypoxia, O2 diffusion and convection, cardiac output, PEEP, Effects of hypoxia
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
threshold PEEPDevice
Various set of pressures : 0, 5, 10 cm H20; pursed lips breathing
| Study group | Role | What they receive |
|---|---|---|
| healthy active subjects | with and without high altitude intolerance Receives: Device: threshold PEEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
SpO2
after three minutes of PEEP vs spontaneous breathing
Measured: mean over 1 minute
Secondary outcomes (3)
peripheral HbO2/DeoxyHb
after three minutes of PEEP / PLB vs. spontaneous breathing
Measured: 1 min
cardiac output
after three min of PEEP vs. spontaneous breathing
Measured: mean over 1 min
pattern of breathing (fR, VT, PETCO2)
after three min of PEEP vs. spontaneous breathing
Measured: 1 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2010 (estimated)
- Study startFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoxiaStudies of the same condition, open and under way.
- 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AGIR à Dom
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bernard Wuyam, MD, PhD, Principal investigator, University Hospital, GrenobleSamuel Vergès, PhD, Study director, Institut National de la Santé Et de la Recherche Médicale, FranceHugo NESPOULET, MsC, Study chair, Université Joseph Fourier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01260428
- Sponsor's protocol ID
- 10-AGIR-2
- Acronym
- hypex
- Status last verified
- Feb 2012
- First submitted
- 14 Dec 2010
- Last updated
- 28 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arterial Oxygenation During Hypoxia : Effects of an Added Expiratory Resistance
- ClinicalTrials.gov ID
- NCT01260428
- Acronym / sponsor ID
- hypex / 10-AGIR-2
- Conditions
- Hypoxia
- Keywords
- hypoxia, O2 diffusion and convection, cardiac output, PEEP, Effects of hypoxia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- AGIR à DomUniversity, hospital or other
- Study start
- Feb 2011
- First posted
- 15 Dec 2010 (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.
Altitude tolerance correlates with the level of oxygenation achieved. The aim of the present study is to investigate whether increased expiratory pressure within the thorax is able to improve oxygenation during hypoxic hypoxia.
Detailed description
Two types of procedures will be tested in a random order, interspaced by resting periods : threshold PEEP set at 5,10 and 15 cm of water and pursed leap breathing.
Subjects will be tested at rest, and during light exercise (30% of sea level predicted VO2max).
FiO2 will be set at 12.5% (4000 m). fc, VE, PETCO2, TA, ECG, cardiac output, and tissular oxygenation will be monitored.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| healthy active subjects | – | Device: threshold PEEPwith and without high altitude intolerance |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- community sample with mounteneering experience
Key inclusion criteria (3 listed)
- active (> 2 hrs/week physical activity)
- adult
- non smoking volunteers
Key exclusion criteria (1 listed)
- cardiac, respiratory, neuromuscular, metabolic pathology
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 |
|---|---|---|
| threshold PEEPVarious set of pressures : 0, 5, 10 cm H20; pursed lips breathing | Device | healthy active subjects |
Primary outcome
SpO2
Time frame: mean over 1 minute
after three minutes of PEEP vs spontaneous breathing
3 secondary outcomes
peripheral HbO2/DeoxyHb
Time frame: 1 min
cardiac output
Time frame: mean over 1 min
pattern of breathing (fR, VT, PETCO2)
Time frame: 1 min
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2012.
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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.
Bernard Wuyam, MD, PhD principal investigator
University Hospital, Grenoble
Samuel Vergès, PhD study director
Institut National de la Santé Et de la Recherche Médicale, France
Hugo NESPOULET, MsC study chair
Université Joseph Fourier
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 Hypoxia, run by AGIR à Dom 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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 28 Feb 2012. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bernard Wuyam, MD, PhD (33 (0)4 76 76 93 03, BWuyam@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SpO2 (time frame: mean over 1 minute). 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 28 Feb 2012.