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

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.

Study Overview

• Status: Completed
• Conditions: Alternative Method of Apnea Test
• Intervention / Treatment: Procedure: Apnea test - CPAP; Procedure: Apnea test - Standard

• Study Type: Observational
• Enrollment (Actual): 208

Contacts and Locations

Study Locations

• France
  • Angers, France, 49933
    • Angers University Hospital
  • Angoulême, France, 16959
    • Angouleme Hospital
  • Bordeaux, France, 33076
    • Bordeaux University Hospital
  • Brest, France, 29200
    • Brest University Hospital
  • Chambray-lès-Tours, France, 37170
    • Tours University Hospital
  • Corbeil-Essonnes, France, 91106
    • Sud Francilien Hospital
  • La Roche sur Yon, France, 85925
    • La Roche Sur Yon Hospital
  • La Rochelle, France, 17019
    • La Rochelle Hospital
  • Limoges, France, 87042
    • Limoges university hospital
  • Nantes, France, 44093
    • Nantes University Hospital
  • Nice, France, 06006
    • Nice University Hospital
  • Orléans, France, 45067
    • Orléans Hospital
  • Paris, France, 75679
    • Cochin University Hospital
  • Poitiers, France, 86000
    • Poitiers university hospital
  • Rennes, France, 35033
    • Rennes University Hospital
  • Saintes, France, 17108
    • Saintes Hospital
  • Toulon, France, 83056
    • Toulon University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Potentiel organs donors in brain death.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Standard group; Apnea test according to the recommendation	Procedure: Apnea test - Standard
CPAP group; Apnea test with CPAP connection	Procedure: Apnea test - CPAP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Eligibility to lung harvest	2 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Poitiers University Hospital
• Investigators: Principal Investigator: Michel PINSARD, Hospital Practitioner, Poitiers university hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: July 26, 2013
• First Submitted That Met QC Criteria: July 26, 2013
• First Posted (Estimate): July 30, 2013

Study Record Updates

• Last Update Posted (Estimate): October 11, 2016
• Last Update Submitted That Met QC Criteria: October 10, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Apnea
• Other Study ID Numbers: APNEE REA