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OpenTrials
Completed

NCT Number: NCT02849561

Evaluation of Prognosis Factors of Neurological Evolution in Cardiac Arrest

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.

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Key information

Conditions

Cardio Respiratory Arrest Cardiovascular Diseases Heart Arrest Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UniversityHospitalGrenoble

La Tronche, 38700, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Therapeutic hypothermia

Other

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

Synchronized Intermittent Mandatory Ventilation

Device

Constant volume 6 ml/kg

Other names: SIMV

Electroencephalography

Other

Other names: EEG

Pupillary light reflex surveillance

Device

With Neurolight® device.

Transcranial Doppler

Device

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

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Official study title

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

Acronym: ACR

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jul 29, 2016
Registry last updated
Jul 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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