Ignite Creation Date:
2024-05-06 @ 2:30 PM
Last Modification Date:
2024-10-26 @ 1:32 PM
Study NCT ID:
NCT04336930
Status:
UNKNOWN
Last Update Posted:
2021-05-24
First Post:
2020-03-10
Brief Title:
Evaluation of the Pupillary Pain Index in Neurological Prognosis After Cardiac Arrest
Sponsor:
Central Hospital Nancy France
Organization:
Central Hospital Nancy France
Study Overview
Official Title:
Evaluation of the Pupillary Dilatation Reflex With the Pupillary Pain Index in Neurological Prognosis After Cardiac Arrest
Status:
UNKNOWN
Status Verified Date:
2021-05
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CAPPI
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
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 andor 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 patients arrival to the CPC score at 3 months
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 andor 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 patients arrival to the CPC score at 3 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None