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

Not Applicable

Completed

• Conditions: Alternative Method of Apnea Test
• Interventions: Procedure: Apnea test - control; Procedure: Apnea test - CPAP

• Registration Number: NCT01649726
• 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, 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-07-23
• Study First Submitted QC: 2012-07-24
• Study First Posted: 2012-07-25
• Study Start: 2013-07
• Primary Completion: 2014-12
• 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 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard strategy	Apnea test - control	Apnea test according to recommendations
CPAP strategy	Apnea test - CPAP	Apnea test with CPAP connection

Primary Outcome Measures

Name	Time	Method
Eligibility to donor lung harvest

Secondary Outcome Measures

Name	Time	Method
Rate of cardiocirculatory disorder
Number of lung transplantation realization
Level of hypoxemia
Rate of ventilatory disorder
Rate of apnea test interruption
Arterial blood gas after th apnea test

Trial Locations

Locations (13)

Angers University Hospital; 🇫🇷 Angers, France

Angoulême Hospital; 🇫🇷 Angoulême, France

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

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

Limoges University Hospital; 🇫🇷 Limoges, France

Nantes University Hospital; 🇫🇷 Nantes, France

Nice University Hospital; 🇫🇷 Nice, France

Cochin University Hospital; 🇫🇷 Paris, France

Orléans Hospital; 🇫🇷 Orléans, France

Rennes University Hospital; 🇫🇷 Rennes, France

Saintes Hospital; 🇫🇷 Saintes, France

Poitiers University Hospital; 🇫🇷 Poitiers, France

La Rochelle Hospital; 🇫🇷 La Rochelle, France