Clinical trial NCT01911286: Comparison of Two Strategies to Realize Apnea Test for the Diagnostic of Brain in Potentiel Organ Donors.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alternative Method of Apnea Test
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2013-07-30
Enrollment: 208
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Potentiel organs donors in brain death.

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.


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

Primary outcomes:
measure: Eligibility to lung harvest
timeFrame: 2 years
Secondary outcomes:
measure: Levels of hypoxemia
timeFrame: 2 years
measure: Arterial blood gas after apnea test
timeFrame: 2 years
measure: Rate of ventilatory impairment
timeFrame: 2 years
measure: Rate of cardiocirculatory impairment
timeFrame: 2 years
measure: Rate of apnea test interruption
timeFrame: 2 years
measure: Number of lung transplantation realization
timeFrame: 2 years
Other outcomes:
Locations:
city: Angers
country: France
facility: Angers University Hospital
city: Angoulême
country: France
facility: Angoulême Hospital
city: Bordeaux
country: France
facility: Bordeaux University Hospital
city: Brest
country: France
facility: Brest University Hospital
city: Chambray-lès-Tours
country: France
facility: Tours University Hospital
city: Corbeil-Essonnes
country: France
facility: Sud Francilien 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
city: Toulon
country: France
facility: Toulon University Hospital
Study officials:
affiliation: Poitiers University Hospital
name: Michel PINSARD, Hospital Practitioner
role: PRINCIPAL_INVESTIGATOR
References: