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

Cardiac Arrest Clinical Trial

— CAPPI  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04336930
• Other study ID #: 2019PI275
• Status: Not yet recruiting
• Start date: November 1, 2021
• Est. completion date: July 1, 2023

Study information

• Verified date: May 2021
• Source: Central Hospital, Nancy, France
• Contact: Matthieu KOSZUTSKI, Dr
• Phone: +33383153017
• Email: m.koszutski[@]chru-nancy.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: July 1, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anoxic Brain Injury
• Brain Injuries
• Cardiac Arrest
• Heart Arrest
• Post-Anoxic Coma

Intervention

Diagnostic Test:
• Pupillary pain index (PPI)
Measurement of PPI with a pupillometer

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Score Cerebral Performance Category (CPC)	Good outcome defined as CPC 1-2, poor outcome defined as CPC 3-5	3 months
Secondary	Characteristics of electroencephalography pattern	Classification of Synek, type of pattern (Very malignant, malignant or benign)	Day 2, day 3, day 5, day 7
Secondary	Biomarkers	Value of seric Neuron Specific Enolase	24 hours, 48 hours
Secondary	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
Secondary	ICU parameters	Ventilator days, Length of stay	Day 14
Secondary	Evoked Potentials	Presence or absence of the N20 component of the evoked potentials	Day 14
Secondary	Neurological pupil index	standardized evaluation of pupil reactivity ranging from 0 (sluggish or abnormal pupils) to 5 (normally reactive pupils)	Day 2, day 3
Secondary	Diameter of the pupil	In millimeters (pupillometry measure)	24 hours, 48 hours, 72 hours
Secondary	Percentage of pupil dilatation	Pupillometry measure	24 hours, 48 hours, 72 hours
Secondary	Latency of pupil dilatation	In milliseconds (pupillometry measure)	24 hours, 48 hours, 72 hours
Secondary	Velocity of pupil dilatation	In millimeters per second (pupillometry measure)	24 hours, 48 hours, 72 hours