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Evaluation of Prognosis Factors of Neurological Evolution in Cardiac Arrest (ACR)

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ClinicalTrials.gov Identifier: NCT02849561
Recruitment Status : Completed
First Posted : July 29, 2016
Last Update Posted : July 29, 2016
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Cardio Respiratory Arrest Other: Therapeutic hypothermia Device: Synchronized Intermittent Mandatory Ventilation Other: Electroencephalography Device: Pupillary light reflex surveillance Device: Transcranial Doppler Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Investigator)
Official Title: Evaluation of Prognosis Factors of Neurological Evolution in Cardiac Arrest : Prospective Study of Routine Care
Study Start Date : January 2014
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiac Arrest

Arm Intervention/treatment
Active Comparator: Favourable neurological evolution after cardiac arrest
MGOS 4-5
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 Name: SIMV

Other: Electroencephalography
Other Name: EEG

Device: Pupillary light reflex surveillance
With Neurolight® device.

Device: Transcranial Doppler
Monitoring tool for brain hemodynamic evaluation. With Philips HD15 Ultrasound system®.

Active Comparator: Unfavourable neurological evolution after cardiac arrest
MGOS 1-3
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 Name: SIMV

Other: Electroencephalography
Other Name: EEG

Device: Pupillary light reflex surveillance
With Neurolight® device.

Device: Transcranial Doppler
Monitoring tool for brain hemodynamic evaluation. With Philips HD15 Ultrasound system®.




Primary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02849561


Locations
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France
UniversityHospitalGrenoble
La Tronche, France, 38700
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
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Principal Investigator: Michel Durand, Doctor Grenoble Hospital University

Publications:
Nolan JP, Neumar RW, Adrie C, Aibiki M, Berg RA, Bbttiger BW, Callaway C, Clark RS, Geocadin RG, Jauch EC, Kern KB, Laurent I, Longstreth WT, Merchant RM, Morley P, Morrison LJ, Nadkarni V, Peberdy MA, Rivers EP, Rodriguez-Nunez A, Sellke FW, Spaulding C, Sunde K, Vanden Hoek T; International Liaison Committee on Resuscitation; Emergency Cardiovascular Care Committee, American Heart Association; Council on Cardiovascular Surgery and Anesthesia; Council on Cardiopulmonary, Perioperative, and Critical Care; Council on Clinical Cardiology; Council on Stroke. Post-cardiac arrest syndrome: epidemiology, pathophysiology, treatment, and prognostication: a scientific statement from the International Liaison Committee on Resuscitation; the American Heart Association Emergency Cardiovascular Care Committee; the Council on Cardiovascular Surgery and Anesthesia; the Council on Cardiopulmonary, Perioperative, and Critical Care; the Council on Clinical Cardiology; the Council on Stroke (Part II). Int Emerg Nurs. 2010 Jan;18(1):8-28. doi: 10.1016/j.ienj.2009.07.001. Epub 2009 Aug 5.

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Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT02849561     History of Changes
Other Study ID Numbers: 38RC13.713
First Posted: July 29, 2016    Key Record Dates
Last Update Posted: July 29, 2016
Last Verified: July 2016
Keywords provided by University Hospital, Grenoble:
Pupillary light reflex
Cardio respiratory arrest
Additional relevant MeSH terms:
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Apnea
Heart Arrest
Heart Diseases
Cardiovascular Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms