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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 is currently recruiting participants.
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
History of Changes

July 23, 2012
March 27, 2013
Not Provided
December 2014   (final data collection date for primary outcome measure)
Eligibility to donor lung harvest
Same as current
Complete list of historical versions of study NCT01649726 on ClinicalTrials.gov Archive Site
  • 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
Same as current
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Comparison of Two Strategies to Realize Apnea Test for the Diagnostic of Brain Death in Potential Organ Donors (CPAPNEE STUDY)
Not Provided

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.
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Interventional
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Alternative Method of Apnea Test
  • Procedure: Apnea test - control
  • Procedure: Apnea test - CPAP
  • Standard strategy
    Apnea test according to recommendations
    Intervention: Procedure: Apnea test - control
  • Experimental: CPAP strategy
    Apnea test with CPAP connection
    Intervention: Procedure: Apnea test - CPAP
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
208
Not Provided
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact: Michel PINSARD, Practitioner +33 5 49 44 42 30 michel.pinsard@chu-poitiers.fr
France
 
NCT01649726
2011-A01390-41
Not Provided
Poitiers University Hospital
Poitiers University Hospital
Not Provided
Not Provided
Poitiers University Hospital
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP