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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04336930
Acronym
CAPPI
Enrollment
60
Registered
2020-04-07
Start date
2021-11-01
Completion date
2023-07-01
Last updated
2021-05-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anoxic Brain Injury, Cardiac Arrest, Post-Anoxic Coma

Keywords

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

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.

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.

Interventions

DIAGNOSTIC_TESTPupillary pain index (PPI)

Measurement of PPI with a pupillometer

Sponsors

Central Hospital, Nancy, France
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Score Cerebral Performance Category (CPC)3 monthsGood outcome defined as CPC 1-2, poor outcome defined as CPC 3-5

Secondary

MeasureTime frameDescription
Biomarkers24 hours, 48 hoursValue of seric Neuron Specific Enolase
Glasgow motor score24 hours, 48 hours, day 5, day 7Motor response component of the Glasgow Coma Scale, ranging from 1 (no response) to 6 (normal response)
ICU parametersDay 14Ventilator days, Length of stay
Evoked PotentialsDay 14Presence or absence of the N20 component of the evoked potentials
Characteristics of electroencephalography patternDay 2, day 3, day 5, day 7Classification of Synek, type of pattern (Very malignant, malignant or benign)
Diameter of the pupil24 hours, 48 hours, 72 hoursIn millimeters (pupillometry measure)
Percentage of pupil dilatation24 hours, 48 hours, 72 hoursPupillometry measure
Latency of pupil dilatation24 hours, 48 hours, 72 hoursIn milliseconds (pupillometry measure)
Velocity of pupil dilatation24 hours, 48 hours, 72 hoursIn millimeters per second (pupillometry measure)
Neurological pupil indexDay 2, day 3standardized evaluation of pupil reactivity ranging from 0 (sluggish or abnormal pupils) to 5 (normally reactive pupils)

Contacts

Primary ContactMatthieu KOSZUTSKI, Dr
m.koszutski@chru-nancy.fr+33383153017

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026