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

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

208 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT01911286

Alternative Method of Apnea Test

COMPLETED

Brain Death Diagnosis at an Academic Tertiary Medical Care Center

NCT03984981

Brain Death

COMPLETED

Resting Energy Needs in Brain Dead Patients (reSting EneRgy nEeds iN brAin DEad Patients)

NCT05070182

Brain Death Brain Injuries Brain Edema +1 more

COMPLETED

Ultrasonic Measurement of the Optic Nerve Sheath Diameter Predicting Outcome After Cardiac Arrest

NCT04084054

Post-Anoxic Coma

UNKNOWN

A Realworld Study of Acute Respiratory Distress Syndrome in China

NCT02975908

Acute Respiratory Distress Syndrome

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Alternative Method of Apnea Test

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Standard strategy

Apnea test according to recommendations

Group Type OTHER

Apnea test - control

Intervention Type PROCEDURE

CPAP strategy

Apnea test with CPAP connection

Group Type EXPERIMENTAL

Apnea test - CPAP

Intervention Type PROCEDURE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Apnea test - control

Intervention Type PROCEDURE

Apnea test - CPAP

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No