Evaluation of Prognosis Factors of Neurological Evolution in Cardiac Arrest (ACR)

July 26, 2016 updated by: University Hospital, Grenoble

Evaluation of Prognosis Factors of Neurological Evolution in Cardiac Arrest : Prospective Study of Routine Care

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

82

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • La Tronche, France, 38700
        • UniversityHospitalGrenoble

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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®.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of the pupillary light reflex variation measured with Neurolight®
Time Frame: One second
Compared between two groups. Favourable neurological evolution after cardiac arrest : MGOS 4-5 Unfavourable neurological evolution after cardiac arrest MGOS 1-3
One second

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

July 21, 2016

First Submitted That Met QC Criteria

July 26, 2016

First Posted (Estimate)

July 29, 2016

Study Record Updates

Last Update Posted (Estimate)

July 29, 2016

Last Update Submitted That Met QC Criteria

July 26, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 38RC13.713

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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