- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01649726
Comparison of Two Strategies to Realize Apnea Test for the Diagnostic of Brain Death in Potential Organ Donors (CPAPNEE STUDY)
October 10, 2016 updated by: Poitiers University Hospital
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, non randomized and with little patients,.
That why the aim of the present study is to compare the standard strategy and CPAP strategy with a prospective, multicenter, randomized study.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
208
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Angers, France, 49933
- Angers University Hospital
-
Angoulême, France, 16959
- Angouleme Hospital
-
Chambray-lès-Tours, France, 37170
- Tours University Hospital
-
La Roche sur Yon, France, 85925
- La Roche Sur Yon Hospital
-
La Rochelle, France, 17019
- La Rochelle Hospital
-
Limoges, France, 87042
- Limoges university hospital
-
Nantes, France, 44093
- Nantes University Hospital
-
Nice, France, 06006
- Nice University Hospital
-
Orléans, France, 45067
- Orléans Hospital
-
Paris, France, 75679
- Cochin University Hospital
-
Poitiers, France, 86021
- Poitiers university hospital
-
Rennes, France, 35033
- Rennes University Hospital
-
Saintes, France, 17108
- Saintes Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age : from 18 to 70 years
- Neurological signs evoking cerebral ischemia
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Standard strategy
Apnea test according to recommendations
|
|
Experimental: CPAP strategy
Apnea test with CPAP connection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Eligibility to donor lung harvest
|
Secondary Outcome Measures
Outcome Measure |
---|
Level of hypoxemia
|
Arterial blood gas after th apnea test
|
Rate of ventilatory disorder
|
Rate of cardiocirculatory disorder
|
Rate of apnea test interruption
|
Number of lung transplantation realization
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2013
Primary Completion (Actual)
December 1, 2014
Study Registration Dates
First Submitted
July 23, 2012
First Submitted That Met QC Criteria
July 24, 2012
First Posted (Estimate)
July 25, 2012
Study Record Updates
Last Update Posted (Estimate)
October 11, 2016
Last Update Submitted That Met QC Criteria
October 10, 2016
Last Verified
October 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CPAPNEE STUDY
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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