NCT Number: NCT01911286
Comparison of Two Strategies to Realize Apnea Test for the Diagnostic of Brain in Potentiel Organ Donors.
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.
Looking for future studies?
Notify MeKey information
Conditions
Age range
18 year–75 year
Sex eligibility
All sexes
Study type
Observational
Primary location
Angers University Hospital, Angers, France
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Apnea test - CPAP
ProcedurePrimary outcomes
-
Eligibility to lung harvest
Time frame: 2 years
Secondary outcomes
-
Levels of hypoxemia
Time frame: 2 years
-
Arterial blood gas after apnea test
Time frame: 2 years
-
Rate of ventilatory impairment
Time frame: 2 years
-
Rate of cardiocirculatory impairment
Time frame: 2 years
-
Rate of apnea test interruption
Time frame: 2 years
-
Number of lung transplantation realization
Time frame: 2 years
Sponsors and collaborators
Lead sponsor
Poitiers University Hospital
Other
Registry information
Acronym: APNEE REA
Important dates
- Study start
- 2013
- Primary completion
- 2015
- First posted
- Jul 30, 2013
- Registry last updated
- Oct 11, 2016
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
Comparison of Two Strategies to Realize Apnea Test for the Diagnostic of Brain Death in Potential Organ Donors (CPAPNEE STUDY)
NCT01649726
Alternative Method of Apnea Test
Angers, France
View Trial Details