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Comparison of Two Strategies to Realize Apnea Test for the Diagnostic of Brain Death in Potential Organ Donors (CPAPNEE STUDY)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2013 by Poitiers University Hospital.
Recruitment status was  Recruiting
Information provided by (Responsible Party):
Poitiers University Hospital Identifier:
First received: July 23, 2012
Last updated: March 27, 2013
Last verified: March 2013
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

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


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01649726

Contact: Michel PINSARD, Practitioner +33 5 49 44 42 30

Angers University Hospital Not yet recruiting
Angers, France, 49933
Contact: Laurent DUBE, Practitioner    +33 2 41 35 36 35   
Principal Investigator: Laurent DUBE, Practitioner         
Angoulême Hospital Not yet recruiting
Angoulême, France, 16959
Contact: Olivier BAUDIN, Practitioner   
Principal Investigator: Olivier BAUDIN, Practitioner         
Tours University Hospital Not yet recruiting
Chambray-lès-Tours, France, 37170
Contact: Marc LAFFON, Professor   
Principal Investigator: Marc LAFFON, Professor         
La Roche sur Yon Hospital Not yet recruiting
La Roche sur Yon, France, 85925
Contact: Laurent MARTIN-LEFEVRE, Practitioner   
Principal Investigator: Laurent MARTIN-LEFEVRE, Practitioner         
La Rochelle Hospital Not yet recruiting
La Rochelle, France, 17019
Contact: Olivier LESIEUR, Practitioner   
Principal Investigator: Olivier LESIEUR, Practitioner         
Limoges University Hospital Not yet recruiting
Limoges, France, 87042
Contact: Nicolas PICHON, Practitioner   
Principal Investigator: Nicolas PICHON, Practitioner         
Nantes University Hospital Not yet recruiting
Nantes, France, 44093
Contact: Karim ASEHNOUNE, Professor   
Principal Investigator: Karim ASEHNOUNE, Professor         
Nice University Hospital Not yet recruiting
Nice, France, 06006
Contact: Carole ICHAI, Professor   
Principal Investigator: Carole ICHAI, Professor         
Orléans Hospital Not yet recruiting
Orléans, France, 45067
Contact: Thierry BOULAIN, Practitioner   
Principal Investigator: Thierry BOULAIN, Practitioner         
Cochin University Hospital Not yet recruiting
Paris, France, 75679
Contact: Julien CHARPENTIER, Practitioner   
Principal Investigator: Julien CHARPENTIER, Practitioner         
Poitiers University Hospital Recruiting
Poitiers, France, 86021
Contact: Michel PINSARD, Practitioner    +33 5 49 44 42 30   
Principal Investigator: Michel PINSARD, Practitioner         
Sub-Investigator: Claire DAHYOT-FIZELIER, Practitioner         
Rennes University Hospital Recruiting
Rennes, France, 35033
Contact: Jean-Paul BLEICHNER, Practitioner   
Principal Investigator: Jean-Paul BLEICHNER, Practitioner         
Saintes Hospital Not yet recruiting
Saintes, France, 17108
Contact: Jean-François VINCENT, Practitioner   
Principal Investigator: Jean-François VINCENT, Practitioner         
Sponsors and Collaborators
Poitiers University Hospital
  More Information

Responsible Party: Poitiers University Hospital 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 processed this record on September 29, 2016