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

Poitiers University Hospital

Status

Completed

Conditions

Alternative Method of Apnea Test

Treatments

Procedure: Apnea test - CPAP

Procedure: Apnea test - control

Study type

Interventional

Funder types

Other

Identifiers

NCT01649726

CPAPNEE STUDY

Details and patient eligibility

About

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.

Enrollment

208 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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