Evaluation of Prognosis Factors of Neurological Evolution in Cardiac Arrest

Cardio Respiratory Arrest Clinical Trial

— ACR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02849561
• Other study ID #: 38RC13.713
• Status: Completed
• Phase: N/A
• First received: July 21, 2016
• Last updated: July 26, 2016
• Start date: January 2014
• Est. completion date: July 2015

Study information

• Verified date: July 2016
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Apnea
• Cardio Respiratory Arrest
• Heart Arrest

Intervention

Other:
• Therapeutic hypothermia
With a mattress at 4°C to reach a central temperature at 33,5°C.

Device:
• Synchronized Intermittent Mandatory Ventilation
Constant volume 6 ml/kg

Other:
• Electroencephalography

Device:
• Pupillary light reflex surveillance
With Neurolight® device.
• Transcranial Doppler
Monitoring tool for brain hemodynamic evaluation. With Philips HD15 Ultrasound system®.

Locations

Country	Name	City	State
France	UniversityHospitalGrenoble	La Tronche

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

References & Publications (32)

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* Note: There are 32 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No