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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01649726

Enrollment

208

Registered

2012-07-25

Start date

2013-07-31

Completion date

Unknown

Last updated

2016-10-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alternative Method of Apnea Test

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.

Interventions

PROCEDUREApnea test - control

PROCEDUREApnea test - CPAP

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Eligibility to donor lung harvest	—

Secondary

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026