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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04336930
Other study ID # 2019PI275
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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