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

Societa Italiana Anestesia Analgesia Rianimazione e Terapia Intensiva

Status: Enrolling

Conditions: Out-Of-Hospital Cardiac Arrest; Cardiac Arrest

Treatments: Device: NPi200

Study type: Observational

Funder types: Other

Identifiers

NCT05192772

2494

Details and patient eligibility

About

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.

Full 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

Enrollment: 214 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Not traumatic cardiac arrest in pre-hospital setting (OHCA)
• unexpected OHCA
• Lombardy region territory

Exclusion criteria

• Traumatic Brain injury
• Cerebrovascular emergecies at computer tomography (CT) scan after hospital admission
• Peripheral or cortical blindness
• One or both eyes loss
• Iris palsy or known peripheral anisocoria
• No indication for resuscitation