Evaluation of Prognosis Factors of Neurological Evolution in Cardiac Arrest

Study Overview
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Brief Summary
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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.

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

Conditions
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Cardio Respiratory Arrest

Intervention / Treatment
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* Other: Therapeutic hypothermia
* Device: Synchronized Intermittent Mandatory Ventilation
* Other: Electroencephalography
* Device: Pupillary light reflex surveillance
* Device: Transcranial Doppler


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Favourable neurological evolution after cardiac arrest<br>MGOS 4-5 | Other: Therapeutic hypothermia<br>* With a mattress at 4°C to reach a central temperature at 33,5°C.<br>Device: Synchronized Intermittent Mandatory Ventilation<br>* Constant volume 6 ml/kg<br>* Other names: SIMV;Other: Electroencephalography<br> <br> * Other names: EEG;Device: Pupillary light reflex surveillance<br>* With Neurolight® device.<br>Device: Transcranial Doppler<br>* Monitoring tool for brain hemodynamic evaluation. With Philips HD15 Ultrasound system®.<br>|
| Active Comparator: Unfavourable neurological evolution after cardiac arrest<br>MGOS 1-3 | Other: Therapeutic hypothermia<br>* With a mattress at 4°C to reach a central temperature at 33,5°C.<br>Device: Synchronized Intermittent Mandatory Ventilation<br>* Constant volume 6 ml/kg<br>* Other names: SIMV;Other: Electroencephalography<br> <br> * Other names: EEG;Device: Pupillary light reflex surveillance<br>* With Neurolight® device.<br>Device: Transcranial Doppler<br>* Monitoring tool for brain hemodynamic evaluation. With Philips HD15 Ultrasound system®.<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pupillary light reflex, Cardio respiratory arrest