Evaluation of the Pupillary Pain Index in Neurological Prognosis After Cardiac Arrest

Study Overview
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Brief Summary
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Two-thirds of patients admitted to the Intensive Care Unit after a cardiac arrest die in the context of treatment withdrawal after a multimodal evaluation that determines an unfavorable neurological outcome. This study will evaluate the Pupillary Pain Index (PPI) in the neurological prognosis after cardiac arrest. The PPI is determined by recording of pupillary dilatation with a videopupillometer after a calibrated and incremented nociceptive stimulus on a cutaneous metamere.

Detailed Description
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Cardiorespiratory arrest is associated with high mortality and morbidity rates. The direct consequence of a cardio-circulatory arrest is the absence of blood flow allowing oxygenation of the organs and consequently formation of ischemic lesions. Anoxic cerebral lesions are common in the aftermath of a cardiac arrest and often lead to the death of patients when active therapies are stopped after a multimodal prognostication that indicates that a poor outcome is very likely. It is of paramount importance to optimize the sensitivity of the prognostication strategy in detecting good neurological outcome. A multimodal approach to the prognostic assessment is essential, and must include at least clinical examination, electrophysiology exploration (electroencephalography and/or evoked potentials) and biomarker analysis. Although the most reliable predictors did not give false positives in most studies, none of them, considered individually, can establish an unfavorable prognosis with an absolute degree of certitude. For these reasons it is interesting to evaluate new prognostication tools. The videopupillometry allows precise, reproducible and repeated measurement of changes in pupil diameter in response to a painful or a luminous stimulus. Pupillary pain reflex analysis is usually used to assess the degree of analgesia in a non-communicative patient during general anesthesia and neuromuscular blockade. The PPI score is determined at the bedside by recording pupillary dilatation after a calibrated and incremented nociceptive stimulus (electrical current between 5 and 60mA) applied to a skin metamere with two electrodes. Automated pupillometry measurement has been recently developed to help support prognostication, with a quantitative pupillary light reflex measurement. The aim of this study is to evaluate the Pupillary Pain Index in the neurological prognosis after a cardiac arrest by correlating the PPI at 48h from the patient's arrival to the CPC score at 3 months.

Official Title
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Evaluation of the Pupillary Dilatation Reflex With the Pupillary Pain Index in Neurological Prognosis After Cardiac Arrest

Conditions
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Cardiac Arrest, Post-Anoxic Coma, Anoxic Brain Injury

Intervention / Treatment
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* Diagnostic Test: Pupillary pain index (PPI)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Admission to the ICU after cardiac arrest Age > 18 years Presenting a Glasgow score of <8 at admission Exclusion Criteria: Pregnancy Ocular pathology making pupillometry impossible. Patient under guardianship or curatorship

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cardiac Arrest group<br>Patients remaining comatose after a cardiac arrest | Diagnostic Test: Pupillary pain index (PPI)<br>* Measurement of PPI with a pupillometer<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score Cerebral Performance Category (CPC) | Good outcome defined as CPC 1-2, poor outcome defined as CPC 3-5 | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characteristics of electroencephalography pattern | Classification of Synek, type of pattern (Very malignant, malignant or benign) | Day 2, day 3, day 5, day 7 | 
| Biomarkers | Value of seric Neuron Specific Enolase | 24 hours, 48 hours | 
| Glasgow motor score | Motor response component of the Glasgow Coma Scale, ranging from 1 (no response) to 6 (normal response) | 24 hours, 48 hours, day 5, day 7 | 
| ICU parameters | Ventilator days, Length of stay | Day 14 | 
| Evoked Potentials | Presence or absence of the N20 component of the evoked potentials | Day 14 | 
| Neurological pupil index | standardized evaluation of pupil reactivity ranging from 0 (sluggish or abnormal pupils) to 5 (normally reactive pupils) | Day 2, day 3 | 
| Diameter of the pupil | In millimeters (pupillometry measure) | 24 hours, 48 hours, 72 hours | 
| Percentage of pupil dilatation | Pupillometry measure | 24 hours, 48 hours, 72 hours | 
| Latency of pupil dilatation | In milliseconds (pupillometry measure) | 24 hours, 48 hours, 72 hours | 
| Velocity of pupil dilatation | In millimeters per second (pupillometry measure) | 24 hours, 48 hours, 72 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pupillometry, Pupillary Pain Index, Brain ischemia, Heart arrest, Neuroprognostication