Alternative Method of Apnea TestAPNEE REANCT01911286
Comparison of Two Strategies to Realize Apnea Test for the Diagnostic of Brain in Potentiel Organ Donors.
An observational study of Alternative Method of Apnea Test, run by Poitiers University Hospital at 17 sites in France.
Trial summary
Clinical diagnostic of brain death requires a non-reactive coma, absence of brain stem reflex, and absence of spontaneous breathing. The confirmation of absence of spontaneous breathing is established the apnea test (according to the American Academy of Neurology's Guidelines). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Alternative Method of Apnea Test
- What is being tested?
- Apnea test - Standard and Apnea test - CPAP
- Type of treatment
- Surgery or procedure
- How many people
- 208 participants
- Where
- 17 sitesFrance
- Study dates
- Jul 2013to Dec 2015
- How long will I take part?
- 1 Day
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Potentiel organs donors in brain death.
Who may be able to join
- Age : from 18 to 75 years
- Neurological signs evoking cerebral ischemia
Who cannot join
- Severe hypoxemia (PaO2/FiO2 < 200) with controlled ventilation (FiO2: 100%)
- Hypothermia < 36°C
- Obesity (BMI ≥ 40) with documented hypopnoea
- Intractable hypotension despite optimal filling and catecholamine doses > 1µg.Kg.min
- Patients with contraindication for organs harvesting.
- Documented chronic respiratory failure
- Progressive infectious acute respiratory disease
- Family opposition to subject's participation in the study
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
France17 sites
Angers University Hospital
Angers, 49933
Angoulême Hospital
Angoulême, 16959
Bordeaux University Hospital
Bordeaux, 33076
Brest University Hospital
Brest, 29200
Tours University Hospital
Chambray-lès-Tours, 37170
Sud Francilien Hospital
Corbeil-Essonnes, 91106
La Roche sur Yon Hospital
La Roche-sur-Yon, 85925
La Rochelle Hospital
La Rochelle, 17019
Limoges University Hospital
Limoges, 87042
Nantes University Hospital
Nantes, 44093
Nice University Hospital
Nice, 06006
Orléans Hospital
Orléans, 45067
Cochin University Hospital
Paris, 75679
Poitiers University Hospital
Poitiers, 86000
Rennes University hospital
Rennes, 35033
Saintes Hospital
Saintes, 17108
Toulon University Hospital
Toulon, 83056
About this study
Clinical diagnostic of brain death requires a non-reactive coma, absence of brain stem reflex, and absence of spontaneous breathing. The confirmation of absence of spontaneous breathing is established the apnea test (according to the American Academy of Neurology's Guidelines). However this test may lead to complications (acute hypoxemia, ventilatory and cardiocirculatory disorders) and reduces significantly the number of lung transplants. Some data suggest modifying the apnea test : replace the ventilator switching off with continuous positive airway pressure (CPAP) use. These studies showed that this alternative method (CPAP) increased the level of lung harvest but they were not sufficient because these studies were monocentric with little patients,. That why the aim of the present study is to compare the standard strategy and CPAP strategy with a prospective, multicenter,cluster trial; each center will use the method of apnea test which it uses usually.
- Conditions
- Alternative Method of Apnea Test
- Being tested
- Apnea test - Standard, Apnea test - CPAP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apnea test - StandardProcedure or surgery
Apnea test - CPAPProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Standard group | Apnea test according to the recommendation Receives: Procedure: Apnea test - Standard | |
| CPAP group | Apnea test with CPAP connection Receives: Procedure: Apnea test - CPAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eligibility to lung harvest
Measured: 2 years
Secondary outcomes (6)
Levels of hypoxemia
Measured: 2 years
Arterial blood gas after apnea test
Measured: 2 years
Rate of ventilatory impairment
Measured: 2 years
Rate of cardiocirculatory impairment
Measured: 2 years
Rate of apnea test interruption
Measured: 2 years
Number of lung transplantation realization
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alternative Method of Apnea TestStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 208 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michel PINSARD, Hospital Practitioner, Principal investigator, Poitiers University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01911286
- Sponsor's protocol ID
- APNEE REA
- Acronym
- APNEE REA
- Status last verified
- Oct 2016
- First submitted
- 26 Jul 2013
- Last updated
- 11 Oct 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Strategies to Realize Apnea Test for the Diagnostic of Brain in Potentiel Organ Donors.
- ClinicalTrials.gov ID
- NCT01911286
- Acronym / sponsor ID
- APNEE REA / APNEE REA
- Conditions
- Alternative Method of Apnea Test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Dec 2015 (actual)
- First posted
- 30 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.
Clinical diagnostic of brain death requires a non-reactive coma, absence of brain stem reflex, and absence of spontaneous breathing. The confirmation of absence of spontaneous breathing is established the apnea test (according to the American Academy of Neurology's Guidelines). However this test may lead to complications (acute hypoxemia, ventilatory and cardiocirculatory disorders) and reduces significantly the number of lung transplants. Some data suggest modifying the apnea test : replace the ventilator switching off with continuous positive airway pressure (CPAP) use. These studies showed that this alternative method (CPAP) increased the level of lung harvest but they were not sufficient because these studies were monocentric with little patients,. That why the aim of the present study is to compare the standard strategy and CPAP strategy with a prospective, multicenter,cluster trial; each center will use the method of apnea test which it uses usually.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard group | – | Procedure: Apnea test - StandardApnea test according to the recommendation |
| CPAP group | – | Procedure: Apnea test - CPAPApnea test with CPAP connection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Potentiel organs donors in brain death.
Key inclusion criteria (2 listed)
- Age : from 18 to 75 years
- Neurological signs evoking cerebral ischemia
Key exclusion criteria (8 listed)
- Severe hypoxemia (PaO2/FiO2 < 200) with controlled ventilation (FiO2: 100%)
- Hypothermia < 36°C
- Obesity (BMI ≥ 40) with documented hypopnoea
- Intractable hypotension despite optimal filling and catecholamine doses > 1µg.Kg.min
- Patients with contraindication for organs harvesting.
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 |
|---|---|---|
| Apnea test - Standard | Procedure or surgery | Standard group |
| Apnea test - CPAP | Procedure or surgery | CPAP group |
Primary outcome
Eligibility to lung harvest
Time frame: 2 years
6 secondary outcomes
Levels of hypoxemia
Time frame: 2 years
Arterial blood gas after apnea test
Time frame: 2 years
Rate of ventilatory impairment
Time frame: 2 years
Rate of cardiocirculatory impairment
Time frame: 2 years
Rate of apnea test interruption
Time frame: 2 years
Number of lung transplantation realization
Time frame: 2 years
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 11 Oct 2016.
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.
Michel PINSARD, Hospital Practitioner principal investigator
Poitiers University Hospital
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alternative Method of Apnea Test, run by Poitiers University Hospital at 17 sites 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 8 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 11 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites 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?
Eligibility to lung harvest (time frame: 2 years). 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 11 Oct 2016.