Evaluation of Prognosis Factors of Neurological Evolution in Cardiac Arrest

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02849561

Acronym

ACR

Enrollment

Registered

2016-07-29

Start date

2014-01-31

Completion date

2015-07-31

Last updated

2016-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardio Respiratory Arrest

Keywords

Pupillary light reflex, Cardio respiratory arrest

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.

Interventions

OTHERTherapeutic hypothermia

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

DEVICESynchronized Intermittent Mandatory Ventilation

Constant volume 6 ml/kg

OTHERElectroencephalography

DEVICEPupillary light reflex surveillance

With Neurolight® device.

DEVICETranscranial Doppler

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

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026