Evaluation of Prognosis Factors of Neurological Evolution in Cardiac Arrest

NCT02849561 | Completed

• 1 other identifier: 38RC13.713
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardio Respiratory Arrest

Keywords

Pupillary light reflex; Cardio respiratory arrest

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Favourable neurological evolution after cardiac arrest

ACTIVE COMPARATOR

MGOS 4-5

Other: Therapeutic hypothermia; Device: Synchronized Intermittent Mandatory Ventilation; Other: Electroencephalography; Device: Pupillary light reflex surveillance; Device: Transcranial Doppler

Unfavourable neurological evolution after cardiac arrest

ACTIVE COMPARATOR

MGOS 1-3

Other: Therapeutic hypothermia; Device: Synchronized Intermittent Mandatory Ventilation; Other: Electroencephalography; Device: Pupillary light reflex surveillance; Device: Transcranial Doppler

Interventions

Therapeutic hypothermia OTHER

With a mattress at 4°C to reach a central temperature at 33,5°C.

Favourable neurological evolution after cardiac arrest; Unfavourable neurological evolution after cardiac arrest

Synchronized Intermittent Mandatory Ventilation DEVICE

Constant volume 6 ml/kg

Also known as: SIMV

Favourable neurological evolution after cardiac arrest; Unfavourable neurological evolution after cardiac arrest

Electroencephalography OTHER

Also known as: EEG

Favourable neurological evolution after cardiac arrest; Unfavourable neurological evolution after cardiac arrest

Pupillary light reflex surveillance DEVICE

With Neurolight® device.

Favourable neurological evolution after cardiac arrest; Unfavourable neurological evolution after cardiac arrest

Transcranial Doppler DEVICE

Monitoring tool for brain hemodynamic evaluation. With Philips HD15 Ultrasound system®.

Favourable neurological evolution after cardiac arrest; Unfavourable neurological evolution after cardiac arrest

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• Refusal from patient or his family
• Age under 18 years
• Pregnant women
• Previous neurological damages
• Persons deprived of liberty by judicial or administrative decision

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

UniversityHospitalGrenoble

La Tronche, 38700, France

Location

Related Publications (32)

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MeSH Terms

Conditions

Heart Arrest

Interventions

Hypothermia, Induced; Ultrasonography, Doppler, Transcranial

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cryotherapy; Therapeutics; Echoencephalography; Neuroradiography; Neuroimaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiography; Ultrasonography; Ultrasonography, Doppler; Diagnostic Techniques, Neurological; Investigative Techniques

Study Officials

• Michel Durand, Doctor

  Grenoble Hospital University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2016
• First Posted: July 29, 2016
• Study Start: January 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: July 29, 2016

Record last verified: 2016-07

Locations

FR (1)