Comparison of Two Strategies to Realize Apnea Test for the Diagnostic of Brain in Potentiel Organ Donors.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Alternative Method of Apnea Test
- Sponsor
- Poitiers University Hospital
- Enrollment
- 208
- Locations
- 17
- Primary Endpoint
- Eligibility to 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 with little patients,. That why the aim of the present study is to compare the standard strategy and CPAP strategy with a prospective, multicenter,cluster trial; each center will use the method of apnea test which it uses usually.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age : from 18 to 75 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 lung harvest
Time Frame: 2 years
Secondary Outcomes
- Rate of apnea test interruption(2 years)
- Number of lung transplantation realization(2 years)
- Levels of hypoxemia(2 years)
- Rate of cardiocirculatory impairment(2 years)
- Arterial blood gas after apnea test(2 years)
- Rate of ventilatory impairment(2 years)