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. (see Contacts and Locations)
Verified March 2013 by Poitiers University Hospital
Sponsor:
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
  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
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 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 July 31, 2014