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ACR: Evaluation of Prognosis Factors of Neurological Evolution in Cardiac Arrest

Sponsor
University Hospital, Grenoble (Other)
Overall Status
Completed
CT.gov ID
NCT02849561
Collaborator
(none)
82
Enrollment
1
Location
2
Arms
17.9
Duration (Months)
4.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

With the repercussion of 55 cases eachyear for 100 000 inhabitants in France, cardio respiratory arrest is a public health issue.

The goal of this study is to evaluate the pupillary light reflex measured by the dimension of the pupil (diameter) as a prognosis factor neurological evolution in post cardiac arrest. By participating to this study, the patient get the same tratments and exams than in a usual managing cares.

In addition of these events, the pupillary light reflex is studied as soon as the patient is accepted in the department, and then on the second day.

Currently, the evaluation of the neurological becoming rely on a multimodal clinical and paraclinical approach.

The study of the pupillary light reflex measured by the diameter of the pupil could be a prognosis factor of neurological evolution for patients in post cardiac arrest, so a reliable and available prognosis marker in patient care.

The goal of this study is to evaluate the pupillary light reflex (RPM), measured by the diameter of the pupil as a prognosis factor of neurological evaluation of admitted patients after a cardiac arrest.

Principal criteria of judgement is the percentage of the pupillary light reflex variation measured with Neurolight®, compared between two groups.

Condition or Disease Intervention/Treatment Phase
  • Other: Therapeutic hypothermia
  • Device: Synchronized Intermittent Mandatory Ventilation
  • Other: Electroencephalography
  • Device: Pupillary light reflex surveillance
  • Device: Transcranial Doppler
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
82 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
Double (Participant, Investigator)
Official Title:
Evaluation of Prognosis Factors of Neurological Evolution in Cardiac Arrest : Prospective Study of Routine Care
Study Start Date :
Jan 1, 2014
Actual Primary Completion Date :
Jul 1, 2015
Actual Study Completion Date :
Jul 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Favourable neurological evolution after cardiac arrest

MGOS 4-5

Other: Therapeutic hypothermia
With a mattress at 4°C to reach a central temperature at 33,5°C.

Device: Synchronized Intermittent Mandatory Ventilation
Constant volume 6 ml/kg
Other Names:
  • SIMV

    • Other: Electroencephalography
    Other Names:
  • EEG

    • Device: Pupillary light reflex surveillance
    With Neurolight® device.

    Device: Transcranial Doppler
    Monitoring tool for brain hemodynamic evaluation. With Philips HD15 Ultrasound system®.
    Active Comparator: Unfavourable neurological evolution after cardiac arrest

    MGOS 1-3

    Other: Therapeutic hypothermia
    With a mattress at 4°C to reach a central temperature at 33,5°C.

    Device: Synchronized Intermittent Mandatory Ventilation
    Constant volume 6 ml/kg
    Other Names:
  • SIMV

    • Other: Electroencephalography
    Other Names:
  • EEG

    • Device: Pupillary light reflex surveillance
    With Neurolight® device.

    Device: Transcranial Doppler
    Monitoring tool for brain hemodynamic evaluation. With Philips HD15 Ultrasound system®.

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of the pupillary light reflex variation measured with Neurolight® [One second]

      Compared between two groups. Favourable neurological evolution after cardiac arrest : MGOS 4-5 Unfavourable neurological evolution after cardiac arrest MGOS 1-3

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Both gender

    • Entry in resuscitation after a cardiac arrest intra or extra-hospital

    • Resumption of a spontaneous cardiac activity

    • Affiliation to a social security system

    Exclusion Criteria:

    • Refusal from patient or his family

    • Age under 18 years

    • Pregnant women

    • Previous neurological damages

    • Persons deprived of liberty by judicial or administrative decision

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UniversityHospitalGrenoble La Tronche France 38700

    Sponsors and Collaborators

    • University Hospital, Grenoble

    Investigators

    • Principal Investigator: Michel Durand, Doctor, Grenoble Hospital University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    University Hospital, Grenoble
    ClinicalTrials.gov Identifier:
    NCT02849561
    Other Study ID Numbers:
    • 38RC13.713
    First Posted:
    Jul 29, 2016
    Last Update Posted:
    Jul 29, 2016
    Last Verified:
    Jul 1, 2016
    Keywords provided by University Hospital, Grenoble
    Pupillary light reflex
    Cardio respiratory arrest
    Additional relevant MeSH terms:
    Heart Arrest

    Study Results

    No Results Posted as of Jul 29, 2016