Evaluation of the "Pupillary Pain Index" in Neurological Prognosis After Cardiac Arrest (CAPPI)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cardiac Arrest; Anoxic Brain Injury; Post-Anoxic Coma
• Intervention / Treatment: Diagnostic test: Pupillary pain index (PPI)

Detailed Description

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.

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

• Study Contact: Name: Matthieu KOSZUTSKI, Dr; Phone Number: +33383153017; Email: m.koszutski@chru-nancy.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients remaining comatose after cardiac arrest

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cardiac Arrest group; Patients remaining comatose after a cardiac arrest	Diagnostic test: Pupillary pain index (PPI); Measurement of PPI with a pupillometer

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France
• Investigators: Principal Investigator: Matthieu Koszutski, Dr, Nancy Teaching Hospital, CHU de Nancy

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): November 1, 2021
• Primary Completion (ANTICIPATED): December 31, 2022
• Study Completion (ANTICIPATED): July 1, 2023

Study Registration Dates

• First Submitted: March 10, 2020
• First Submitted That Met QC Criteria: April 5, 2020
• First Posted (ACTUAL): April 7, 2020

Study Record Updates

• Last Update Posted (ACTUAL): May 24, 2021
• Last Update Submitted That Met QC Criteria: May 21, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Heart arrest; Pupillometry; Brain ischemia; Pupillary Pain Index; Neuroprognostication
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Heart Arrest
• Other Study ID Numbers: 2019PI275

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No