Comparison of Two Strategies to Realize Apnea Test for the Diagnostic of Brain Death in Potential Organ Donors (CPAPNEE STUDY)
This study is currently recruiting participants.
Verified March 2013 by Poitiers University Hospital
Sponsor:
Poitiers University Hospital
Information provided by (Responsible Party):
Poitiers University Hospital
ClinicalTrials.gov Identifier:
NCT01649726
First received: July 23, 2012
Last updated: March 27, 2013
Last verified: March 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Alternative Method of Apnea Test |
Procedure: Apnea test - control Procedure: Apnea test - CPAP |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label |
Resource links provided by NLM:
Further study details as provided by Poitiers University Hospital:
Primary Outcome Measures:
- Eligibility to donor lung harvest
Secondary Outcome Measures:
- 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
| Estimated Enrollment: | 208 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Standard strategy
Apnea test according to recommendations
|
Procedure: Apnea test - control |
|
Experimental: CPAP strategy
Apnea test with CPAP connection
|
Procedure: Apnea test - CPAP |
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01649726
Contacts
| Contact: Michel PINSARD, Practitioner | +33 5 49 44 42 30 | michel.pinsard@chu-poitiers.fr |
Locations
| France | |
| Angers University Hospital | Not yet recruiting |
| Angers, France, 49933 | |
| Contact: Laurent DUBE, Practitioner +33 2 41 35 36 35 ladube@chu-angers.fr | |
| Principal Investigator: Laurent DUBE, Practitioner | |
| Angoulême Hospital | Not yet recruiting |
| Angoulême, France, 16959 | |
| Contact: Olivier BAUDIN, Practitioner olivier.baudin@ch-angouleme.fr | |
| Principal Investigator: Olivier BAUDIN, Practitioner | |
| Tours University Hospital | Not yet recruiting |
| Chambray-lès-Tours, France, 37170 | |
| Contact: Marc LAFFON, Professor laffon@med.univ-tours.fr | |
| Principal Investigator: Marc LAFFON, Professor | |
| La Roche sur Yon Hospital | Not yet recruiting |
| La Roche sur Yon, France, 85925 | |
| Contact: Laurent MARTIN-LEFEVRE, Practitioner laurent.martin-lefevre@chd-vendee.fr | |
| Principal Investigator: Laurent MARTIN-LEFEVRE, Practitioner | |
| La Rochelle Hospital | Not yet recruiting |
| La Rochelle, France, 17019 | |
| Contact: Olivier LESIEUR, Practitioner olivier.lesieur@ch-larochelle.fr | |
| Principal Investigator: Olivier LESIEUR, Practitioner | |
| Limoges University Hospital | Not yet recruiting |
| Limoges, France, 87042 | |
| Contact: Nicolas PICHON, Practitioner nicolas.pichon@chu-limoges.fr | |
| Principal Investigator: Nicolas PICHON, Practitioner | |
| Nantes University Hospital | Not yet recruiting |
| Nantes, France, 44093 | |
| Contact: Karim ASEHNOUNE, Professor karim.asehnoune@chu-nantes.fr | |
| Principal Investigator: Karim ASEHNOUNE, Professor | |
| Nice University Hospital | Not yet recruiting |
| Nice, France, 06006 | |
| Contact: Carole ICHAI, Professor ichai@unice.fr | |
| Principal Investigator: Carole ICHAI, Professor | |
| Orléans Hospital | Not yet recruiting |
| Orléans, France, 45067 | |
| Contact: Thierry BOULAIN, Practitioner thierry.boulain@ch-orleans.fr | |
| Principal Investigator: Thierry BOULAIN, Practitioner | |
| Cochin University Hospital | Not yet recruiting |
| Paris, France, 75679 | |
| Contact: Julien CHARPENTIER, Practitioner julien.charpentier@cch.aphp.fr | |
| Principal Investigator: Julien CHARPENTIER, Practitioner | |
| Poitiers University Hospital | Recruiting |
| Poitiers, France, 86021 | |
| Contact: Michel PINSARD, Practitioner +33 5 49 44 42 30 michel.pinsard@chu-poitiers.fr | |
| Principal Investigator: Michel PINSARD, Practitioner | |
| Sub-Investigator: Claire DAHYOT-FIZELIER, Practitioner | |
| Rennes University Hospital | Recruiting |
| Rennes, France, 35033 | |
| Contact: Jean-Paul BLEICHNER, Practitioner jean-paul.bleichner@chu-rennes.fr | |
| Principal Investigator: Jean-Paul BLEICHNER, Practitioner | |
| Saintes Hospital | Not yet recruiting |
| Saintes, France, 17108 | |
| Contact: Jean-François VINCENT, Practitioner j.vincent@ch-saintonges.fr | |
| Principal Investigator: Jean-François VINCENT, Practitioner | |
Sponsors and Collaborators
Poitiers University Hospital
More Information
No publications provided
| Responsible Party: | Poitiers University Hospital |
| ClinicalTrials.gov Identifier: | NCT01649726 History of Changes |
| Other Study ID Numbers: | 2011-A01390-41 |
| Study First Received: | July 23, 2012 |
| Last Updated: | March 27, 2013 |
| Health Authority: | France: Agence Nationale de Sécurité du Médicament et des produits de santé |
Additional relevant MeSH terms:
|
Apnea Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory Signs and Symptoms |
ClinicalTrials.gov processed this record on June 17, 2013