Working… Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01649726
Recruitment Status : Completed
First Posted : July 25, 2012
Last Update Posted : October 11, 2016
Information provided by (Responsible Party):
Poitiers University Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Alternative Method of Apnea Test Procedure: Apnea test - control Procedure: Apnea test - CPAP Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 208 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Study Start Date : July 2013
Actual Primary Completion Date : December 2014

Arm Intervention/treatment
Standard strategy
Apnea test according to recommendations
Procedure: Apnea test - control
Experimental: CPAP strategy
Apnea test with CPAP connection
Procedure: Apnea test - CPAP

Primary Outcome Measures :
  1. Eligibility to donor lung harvest

Secondary Outcome Measures :
  1. Level of hypoxemia
  2. Arterial blood gas after th apnea test
  3. Rate of ventilatory disorder
  4. Rate of cardiocirculatory disorder
  5. Rate of apnea test interruption
  6. Number of lung transplantation realization

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01649726

Layout table for location information
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

Layout table for additonal information
Responsible Party: Poitiers University Hospital Identifier: NCT01649726     History of Changes
Other Study ID Numbers: CPAPNEE STUDY
First Posted: July 25, 2012    Key Record Dates
Last Update Posted: October 11, 2016
Last Verified: October 2016
Additional relevant MeSH terms:
Layout table for MeSH terms
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms