Clinical trial NCT01649726: Comparison of Two Strategies to Realize Apnea Test for the Diagnostic of Brain Death in Potential Organ Donors (CPAPNEE STUDY)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alternative Method of Apnea Test
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2012-07-25
Enrollment: 208
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.


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

Primary outcomes:
measure: Eligibility to donor lung harvest
Secondary outcomes:
measure: Level of hypoxemia
measure: Arterial blood gas after th apnea test
measure: Rate of ventilatory disorder
measure: Rate of cardiocirculatory disorder
measure: Rate of apnea test interruption
measure: Number of lung transplantation realization
Other outcomes:
Locations:
city: Angers
country: France
facility: Angers University Hospital
city: Angoulême
country: France
facility: Angoulême Hospital
city: Chambray-lès-Tours
country: France
facility: Tours University Hospital
city: La Roche sur Yon
country: France
facility: La Roche sur Yon Hospital
city: La Rochelle
country: France
facility: La Rochelle Hospital
city: Limoges
country: France
facility: Limoges University Hospital
city: Nantes
country: France
facility: Nantes University Hospital
city: Nice
country: France
facility: Nice University Hospital
city: Orléans
country: France
facility: Orléans Hospital
city: Paris
country: France
facility: Cochin University Hospital
city: Poitiers
country: France
facility: Poitiers University Hospital
city: Rennes
country: France
facility: Rennes University Hospital
city: Saintes
country: France
facility: Saintes Hospital
Study officials:
References: