Evaluation of Prognosis Factors of Neurological Evolution in Cardiac Arrest

Not Applicable

Completed

• Conditions: Cardio Respiratory Arrest
• Interventions: Other: Therapeutic hypothermia; Device: Synchronized Intermittent Mandatory Ventilation; Other: Electroencephalography; Device: Pupillary light reflex surveillance; Device: Transcranial Doppler

• Registration Number: NCT02849561
• Lead Sponsor: University Hospital, Grenoble

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2016-07
• Study First Submitted: 2016-07-21
• Study First Submitted QC: 2016-07-26
• Last Update Submitted: 2016-07-26
• Study First Posted: 2016-07-29
• Last Update Posted: 2016-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Favourable neurological evolution after cardiac arrest	Synchronized Intermittent Mandatory Ventilation	MGOS 4-5
Favourable neurological evolution after cardiac arrest	Electroencephalography	MGOS 4-5
Unfavourable neurological evolution after cardiac arrest	Therapeutic hypothermia	MGOS 1-3
Favourable neurological evolution after cardiac arrest	Therapeutic hypothermia	MGOS 4-5
Unfavourable neurological evolution after cardiac arrest	Electroencephalography	MGOS 1-3
Favourable neurological evolution after cardiac arrest	Pupillary light reflex surveillance	MGOS 4-5
Favourable neurological evolution after cardiac arrest	Transcranial Doppler	MGOS 4-5
Unfavourable neurological evolution after cardiac arrest	Synchronized Intermittent Mandatory Ventilation	MGOS 1-3
Unfavourable neurological evolution after cardiac arrest	Pupillary light reflex surveillance	MGOS 1-3
Unfavourable neurological evolution after cardiac arrest	Transcranial Doppler	MGOS 1-3

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

UniversityHospitalGrenoble; 🇫🇷 La Tronche, France