Comparison of Two Strategies to Realize Apnea Test for the Diagnostic of Brain in Potentiel Organ Donors.

NCT ID: NCT01911286

Last Updated: 2016-10-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

208 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Alternative Method of Apnea Test

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Standard group

Apnea test according to the recommendation

Apnea test - Standard

Intervention Type PROCEDURE

CPAP group

Apnea test with CPAP connection

Apnea test - CPAP

Intervention Type PROCEDURE

Interventions

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Apnea test - Standard

Intervention Type PROCEDURE

Apnea test - CPAP

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Poitiers University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michel PINSARD, Hospital Practitioner

Role: PRINCIPAL_INVESTIGATOR

Poitiers University Hospital

Locations

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Angers University Hospital

Angers, , France

Site Status

Angoulême Hospital

Angoulême, , France

Site Status

Bordeaux University Hospital

Bordeaux, , France

Site Status

Brest University Hospital

Brest, , France

Site Status

Tours University Hospital

Chambray-lès-Tours, , France

Site Status

Sud Francilien Hospital

Corbeil-Essonnes, , France

Site Status

La Roche sur Yon Hospital

La Roche-sur-Yon, , France

Site Status

La Rochelle Hospital

La Rochelle, , France

Site Status

Limoges University Hospital

Limoges, , France

Site Status

Nantes University Hospital

Nantes, , France

Site Status

Nice University Hospital

Nice, , France

Site Status

Orléans Hospital

Orléans, , France

Site Status

Cochin University Hospital

Paris, , France

Site Status

Poitiers University Hospital

Poitiers, , France

Site Status

Rennes University hospital

Rennes, , France

Site Status

Saintes Hospital

Saintes, , France

Site Status

Toulon University Hospital

Toulon, , France

Site Status

Countries

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France

Other Identifiers

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APNEE REA

Identifier Type: -

Identifier Source: org_study_id

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