Cognitive Auditory Evoked Potential After Cardiac Arrest: Interest of Mismatch negativiTY (CAPACITY)

Cognitive Auditory Evoked Potential After Cardiac Arrest: Interest of Mismatch negativiTY: The CAPACITY Study

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.

Study Overview

• Status: Completed
• Conditions: Cardiac Arrest; Coma
• Intervention / Treatment: Procedure: Auditory-evoked potentials

Detailed Description

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:

• To assess the capacity of the presence of the mismatch negativity during the cortical auditory-evoked potential to predict awakening during the hospitalisation stay.
• To determine the optimal time of realization of the cortical auditory-evoked potential
• To determine the capacity of the presence of the mismatch negativity during the cortical auditory-evoked potential to predict ICU discharge and/or hospital discharge favorable outcome in comatose survivors after cardiac arrest
• To determine the impact of the sedations drugs during the hypothermia phase, and during the ICU stay The main judgement criterion is the 1-year CPC score (CPC 1 to 2 as a favorable outcome)

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.

• Study Type: Interventional
• Enrollment (Actual): 85
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75010
    • Lariboisière Hospital - Medical and toxicology unit
  • Versailles, France, 78150
    • Dr Stéphane LEGRIEL - Intensive Care Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adults (age ≥ 18 years)
• hospitalized in the intensive care unit in the aftermath of a intra-or extra-hospital cardiac arrest
• alive but remaining comatose between the 2nd day and the 5th day after cardiopulmonary arrest

Exclusion Criteria:

• moribund patients (treatment limitations or the life expectancy of the inclusion estimated at less than 1 year)
• patient awake at day of potential inclusion
• brain death state
• failure to realize the cortical
• patient whose hearing loss is known

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: 1:Mismatch negativity; Presence of the mismatch negativity during the cortical auditory-evoked potential would predict a favorable outcome in comatose survivors after cardiac arrest.	Procedure: Auditory-evoked potentials; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CPC score of 1 or 2 (favorable outcome)	1-year CPC score of 1 or 2 (favorable outcome)	1 year

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Stephane LEGRIEL, MD, Versailles Hospital - 78150 Le Chesnay - France

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2013
• Primary Completion (ACTUAL): June 1, 2018
• Study Completion (ACTUAL): June 1, 2019

Study Registration Dates

• First Submitted: October 24, 2013
• First Submitted That Met QC Criteria: November 4, 2013
• First Posted (ESTIMATE): November 11, 2013

Study Record Updates

• Last Update Posted (ACTUAL): August 20, 2020
• Last Update Submitted That Met QC Criteria: August 19, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Cardiac arrest; Coma; Neurophysiology; Auditory evoked potential
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Arrest
• Other Study ID Numbers: P091118; 2010-A01378-31 (OTHER: IDRCB)