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

NCT04336930 | Unknown

• 1 other identifier: 2019PI275
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Cardiac Arrest; Post-Anoxic Coma; Anoxic Brain Injury

Keywords

Pupillometry; Pupillary Pain Index; Brain ischemia; Heart arrest; Neuroprognostication

Outcome Measures

Primary Outcomes (1)

• Score Cerebral Performance Category (CPC)

  Good outcome defined as CPC 1-2, poor outcome defined as CPC 3-5

  3 months

Secondary Outcomes (10)

• Characteristics of electroencephalography pattern

  Day 2, day 3, day 5, day 7

• Biomarkers

  24 hours, 48 hours

• Glasgow motor score

  24 hours, 48 hours, day 5, day 7

• ICU parameters

  Day 14

• Evoked Potentials

  Day 14

Study Arms (1)

Cardiac Arrest group

Patients remaining comatose after a cardiac arrest

Diagnostic Test: Pupillary pain index (PPI)

Interventions

Pupillary pain index (PPI) DIAGNOSTIC_TEST

Measurement of PPI with a pupillometer

Cardiac Arrest group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients remaining comatose after cardiac arrest

You may qualify if:

• Admission to the ICU after cardiac arrest
• Age \> 18 years
• Presenting a Glasgow score of \<8 at admission

You may not qualify if:

• Pregnancy
• Ocular pathology making pupillometry impossible.
• Patient under guardianship or curatorship

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

MeSH Terms

Conditions

Heart Arrest; Hypoxia-Ischemia, Brain; Brain Ischemia

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypoxia, Brain; Vascular Diseases; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Matthieu Koszutski, Dr

  Nancy Teaching Hospital, CHU de Nancy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthieu KOSZUTSKI, Dr

CONTACT

+33383153017; m.koszutski@chru-nancy.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2020
• First Posted: April 7, 2020
• Study Start: November 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: July 1, 2023
• Last Updated: May 24, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share