Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2010-A01378-31 | Other Identifier | IDRCB |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Determination of vital and functional outcome in comatose survivors after cardiac arrest is principally based on the identification of predictors of non-awakening, using by clinical, biological and electrophysiological tools. In patients without presence of non-awakening predictors, it would be of interest to identify predictive criteria of awakening. The presence of mismatch negativity during the cortical auditory-evoked potential could contribute to further progress in neurological prognostication of these patients. However, at this time, its prognostic value has been insufficiently studied and the optimal time of realization remains unknown.
We hypothesized that the presence of the mismatch negativity during the cortical auditory-evoked potential would predict a favorable outcome in comatose survivors after cardiac arrest.The main objective is to determine the capacity of the presence of the mismatch negativity during the cortical auditory-evoked potential to predict a 1-year favorable outcome in comatose survivors after cardiac arrest
The secondary objectives are:
Study design : Prospective, multicentre, interventional study. Decision making to withdrawal of life support will be strictly codified according current knowledge and standardized among the participating centres. In the absence of predictors of non-awakening, care will be continued without limitation. The design of the study will focus on the determination of the capacity of the presence of the mismatch negativity during the cortical auditory-evoked potential to predict awakening. Cortical auditory-evoked potential will be performed bedside in the ICU by qualified neurophysiologists. Results of cortical auditory-evoked potential will remain blinded of bedside clinicians providing care for the patients. Awakening will be assessed bedside daily. CPC score will be evaluated at discharge of the ICU, of the hospital, at 3 months and 1 year by an independent evaluator, blinded of the results of the cortical auditory-evoked potentials.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1:Mismatch negativity | Other | Presence of the mismatch negativity during the cortical auditory-evoked potential would predict a favorable outcome in comatose survivors after cardiac arrest. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Auditory-evoked potentials | Procedure | cortical auditory-evoked potentials are performed to all included patients at inclusion, at day 5 to day 10, day without sedation (up to 1 year), day of awakening |
| Measure | Description | Time Frame |
|---|---|---|
| CPC score of 1 or 2 (favorable outcome) | 1-year CPC score of 1 or 2 (favorable outcome) | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Awakeness | Awakeness during the hospitalisation stay | up to 1 year |
| Time of realization of the cortical auditory-evoked potential | the optimal time of realization of the cortical auditory-evoked potential |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Stephane LEGRIEL, MD | Versailles Hospital - 78150 Le Chesnay - France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lariboisière Hospital - Medical and toxicology unit | Paris | 75010 | France | |||
| Dr Stéphane LEGRIEL - Intensive Care Unit |
Not provided
| ID | Term |
|---|---|
| D003128 | Coma |
| D006323 | Heart Arrest |
| ID | Term |
|---|---|
| D014474 | Unconsciousness |
| D003244 | Consciousness Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
Not provided
Not provided
| ID | Term |
|---|---|
| D005072 | Evoked Potentials, Auditory |
| ID | Term |
|---|---|
| D005071 | Evoked Potentials |
| D000071080 | Cortical Excitability |
| D055724 | Electrophysiological Phenomena |
| D010829 | Physiological Phenomena |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| up to 1 year |
| CPC score of 1 or 2 at ICU discharge | the CPC score of 1 or 2 at ICU and at hospital discharge | up to 1 year |
| Length of mechanical ventilation, ICU stay, hospital stay and vital status at discharge | impact of the sedations drugs during the ICU stay impact of therapeutic hypothermia | up to 1 year |
| CPC score of 1 or 2 at hospital discharge | the CPC score of 1 or 2 at hospital discharge | up to 1 year |
| Versailles |
| 78150 |
| France |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D000084323 | Vestibulocochlear Physiological Phenomena |
| D009424 | Nervous System Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |