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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Poitiers University Hospital
ClinicalTrials.gov Identifier:
NCT01649726
First received: July 23, 2012
Last updated: October 10, 2016
Last verified: October 2016
  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

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

Enrollment: 208
Study Start Date: July 2013
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   (Adult, Senior)
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

Locations
France
Angers University Hospital
Angers, France, 49933
Angoulême Hospital
Angoulême, France, 16959
Tours University Hospital
Chambray-lès-Tours, France, 37170
La Roche sur Yon Hospital
La Roche sur Yon, France, 85925
La Rochelle Hospital
La Rochelle, France, 17019
Limoges University Hospital
Limoges, France, 87042
Nantes University Hospital
Nantes, France, 44093
Nice University Hospital
Nice, France, 06006
Orléans Hospital
Orléans, France, 45067
Cochin University Hospital
Paris, France, 75679
Poitiers University Hospital
Poitiers, France, 86021
Rennes University Hospital
Rennes, France, 35033
Saintes Hospital
Saintes, France, 17108
Sponsors and Collaborators
Poitiers University Hospital
  More Information

Responsible Party: Poitiers University Hospital
ClinicalTrials.gov Identifier: NCT01649726     History of Changes
Other Study ID Numbers: CPAPNEE STUDY 
Study First Received: July 23, 2012
Last Updated: October 10, 2016
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

ClinicalTrials.gov processed this record on December 07, 2016