NCT05192772

Early Neurological Assessment With Pupillometry in Cardiac Arrest During Resuscitation

EASY CARE Early Neurological Assessment With Pupillometry in Cardiac Arrest During Resuscitation

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 214 (estimated)
• Sponsor: Societa Italiana Anestesia Analgesia Rianimazione e Terapia Intensiva · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Easy Care study wants to demonstrate a correlation between intra-CPR infrared quantitative pupillometry and return of spontaneous circulation (ROSC). Neurological pupil index (NPi) will be used alone and in association with end-tidal CO2.

Detailed description

At the arrival of medicalised rescue team on the emergency scene, patient will be screened for including criteria. In case of eligibility pupillometry will be collected each eye in the following frame time: * T 0: time of enrolling * T 1: after first cycle of resuscitation (approximatively 2 minutes following guidelines) * T 2 … Tn: every cycle of CPR (or every 2 minutes if intubated patient) bilateral pupillometry will be collected * T end: the last pupillometry at ROSC time or death. All pupillometry mesures will be obtained from a technician not trained to interpret NPi index. This to maintain blindness during resuscitation efforts. Data will be collected in anonymous web-based database passwords protected. For the survivors patients enrolled, data collecting continue in Intensive Care Unit (ICU) as neuroprognostication exams (biomarkers, imaging, neurophysiology). Blind follow up will be obtained from ICU as described in secondary outcome section

Conditions

• Cardiac Arrest
• Out-Of-Hospital Cardiac Arrest

Interventions

Type	Name	Description
DEVICE	NPi200	Digital pupillometry performed during cardiopulmonary resuscutation (CPR) every CPR cycle end in case of not intubated patient, or every 2 minutes in case of intubated patient

Timeline

• Start date: 2022-12-01
• Primary completion: 2023-07-01
• Completion: 2023-12-15
• First posted: 2022-01-14
• Last updated: 2022-10-26

Locations

1 site across 1 country: Italy