Auditory-evoked potentials
Procedurecortical 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
NCT Number: NCT01980446
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Lariboisière Hospital - Medical and toxicology unit, Paris, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: 1 year
1-year CPC score of 1 or 2 (favorable outcome)
Time frame: up to 1 year
Awakeness during the hospitalisation stay
Time frame: up to 1 year
the optimal time of realization of the cortical auditory-evoked potential
Time frame: up to 1 year
the CPC score of 1 or 2 at ICU and at hospital discharge
Time frame: up to 1 year
impact of the sedations drugs during the ICU stay impact of therapeutic hypothermia
Time frame: up to 1 year
the CPC score of 1 or 2 at hospital discharge
Assistance Publique - Hôpitaux de Paris
Other
Cognitive Auditory Evoked Potential After Cardiac Arrest: Interest of Mismatch negativiTY: The CAPACITY Study
Acronym: CAPACITY
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.
Published trials that share one or more normalized conditions with this study.
NCT07020091
Brain Diseases, Brain Ischemia
Diyarbakır, Kayapinar, Turkey (Türkiye)
View Trial DetailsNCT02442791
Cardiac Arrest, Cardiovascular Diseases
Copenhagen, Denmark
View Trial DetailsNCT00644722
Cardiac Arrest, Cardiovascular Diseases
Créteil, Île-de-France Region, France
View Trial DetailsNCT06617377
Cardiac Arrest, Cardiovascular Diseases
Toulouse, France
View Trial Details