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Clinical Trials/NCT01649726
NCT01649726
Completed
Not Applicable

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

Poitiers University Hospital13 sites in 1 country208 target enrollmentJuly 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Alternative Method of Apnea Test
Sponsor
Poitiers University Hospital
Enrollment
208
Locations
13
Primary Endpoint
Eligibility to donor lung harvest
Status
Completed
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2013
End Date
December 2014
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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

Outcomes

Primary Outcomes

Eligibility to donor lung harvest

Secondary Outcomes

  • Number of lung transplantation realization
  • Rate of cardiocirculatory disorder
  • Level of hypoxemia
  • Rate of ventilatory disorder
  • Rate of apnea test interruption
  • Arterial blood gas after th apnea test

Study Sites (13)

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