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

Completed

• Conditions: Alternative Method of Apnea Test

• Registration Number: NCT01911286
• Lead Sponsor: Poitiers University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-07-26
• Study First Submitted QC: 2013-07-26
• Study First Posted: 2013-07-30
• Primary Completion: 2015-12
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-10
• Last Update Posted: 2016-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 208

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Eligibility to lung harvest	2 years

Secondary Outcome Measures

Name	Time	Method
Levels of hypoxemia	2 years
Rate of cardiocirculatory impairment	2 years
Rate of apnea test interruption	2 years
Number of lung transplantation realization	2 years
Arterial blood gas after apnea test	2 years
Rate of ventilatory impairment	2 years

Trial Locations

Locations (17)

Angers University Hospital; 🇫🇷 Angers, France

Angoulême Hospital; 🇫🇷 Angoulême, France

Bordeaux University Hospital; 🇫🇷 Bordeaux, France

Brest University Hospital; 🇫🇷 Brest, France

Tours University Hospital; 🇫🇷 Chambray-lès-Tours, France

Sud Francilien Hospital; 🇫🇷 Corbeil-Essonnes, France

La Roche sur Yon Hospital; 🇫🇷 La Roche sur Yon, France

La Rochelle Hospital; 🇫🇷 La Rochelle, France

Limoges University Hospital; 🇫🇷 Limoges, France

Nantes University Hospital; 🇫🇷 Nantes, France

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