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

NCT01980446 | Completed DMC

• 2 other identifiers: P0911182010-A01378-31
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Coma; Cardiac Arrest

Keywords

Coma; Cardiac arrest; Neurophysiology; Auditory evoked potential

Outcome Measures

Primary Outcomes (1)

• CPC score of 1 or 2 (favorable outcome)

  1-year CPC score of 1 or 2 (favorable outcome)

  1 year

Secondary Outcomes (5)

• Awakeness

  up to 1 year

• Time of realization of the cortical auditory-evoked potential

  up to 1 year

• CPC score of 1 or 2 at ICU discharge

  up to 1 year

• Length of mechanical ventilation, ICU stay, hospital stay and vital status at discharge

  up to 1 year

• CPC score of 1 or 2 at hospital discharge

  up to 1 year

Study Arms (1)

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.

Procedure: Auditory-evoked potentials

Interventions

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

1:Mismatch negativity

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• brain death state
• failure to realize the cortical
• patient whose hearing loss is known

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (2)

Lariboisière Hospital - Medical and toxicology unit

Paris, 75010, France

Location

Dr Stéphane LEGRIEL - Intensive Care Unit

Versailles, 78150, France

Location

MeSH Terms

Conditions

Coma; Heart Arrest

Interventions

Evoked Potentials, Auditory

Condition Hierarchy (Ancestors)

Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Evoked Potentials; Cortical Excitability; Electrophysiological Phenomena; Physiological Phenomena; Vestibulocochlear Physiological Phenomena; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Stephane LEGRIEL, MD

  Versailles Hospital - 78150 Le Chesnay - France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2013
• First Posted: November 11, 2013
• Study Start: December 1, 2013
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2019
• Last Updated: August 20, 2020

Record last verified: 2020-08

Locations

FR (2)