Early Neurological Assessment With Pupillometry in Cardiac Arrest During Resuscitation

Recruiting

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

• Registration Number: NCT05192772
• Lead Sponsor: Societa Italiana Anestesia Analgesia Rianimazione e Terapia Intensiva

Brief 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

Study Timeline

• Study First Submitted: 2021-11-25
• Study First Submitted QC: 2021-12-30
• Study First Posted: 2022-01-14
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-25
• Last Update Posted: 2022-10-26
• Study Start: 2022-12-01
• Primary Completion: 2023-07-01
• Study Completion: 2023-12-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 214

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Return of spontaneous circulation (ROSC) prediction	Variable because depends on the cardiac resuscitation manoeuvers lasting usually not more than 45 minutes	We are searching for possible correlation between pupillary reactivity (NPi) collected during resuscitation manoeuvres and ROSC. NPi is a numeric score ranges from 0 (unreactive pupils) and 5 (normal reflex).

Secondary Outcome Measures

Name	Time	Method
Correlation between NPi trend and ROSC	Variable because depends on the cardiac resuscitation manoeuvers lasting usually not more than 45 minutes	We are searching for a possible correlation between the NPi trend during cardiac pulmonary resuscitation (CPR) and the ROSC. We suppose that an improvement of NPi values during CPR can indicate a progressive oxygenation and functionality of tissues with an increased probability of ROSC
Correlation of NPi and end tidal CO2 (ETCO2) and ROSC prediction	Variable because depends on the cardiac resuscitation manoeuvers lasting usually not more than 45 minutes	NPi meaning has been described previously, ETCO2 represents the amount of CO2 exhaled during ventilation in course of cardiopulmonary resuscitation. It represent a good indicator of tissues reperfusion.; We suppose that NPi could reflect the brainstem vitality. We want to demonstrate if the association between a well known indicator as ETCO2 and the NPi may emprove the ROSC prediction compared to NPi alone (primary objective).
Correlation between NPi and Neurological Outcome as Modified Rankin Scale (mRS)	1 month, 6 months, 1 year	association between pupillary reactivity (NPi) absence and poor neurological outcome. The outcome will be evaluated in using modified Rankin Scale range from 0 (no symptoms) to 6 (death). We will aggregate the outcome in a dichotomised result as: good outcome (mRS 0-4) and poor outcome (mRS 5-6).; The exams of patients will be performed at 1 month, 6 month (or hospital discharge) and 1 year from ROSC, and at ICU discharge.; The patients exams will be performed with a telephone interview about their fisical condition accordingly to mRS score description.
Correlation between NPi trend and mRS in ROSC patients	1 month, 6 months, 1 year	Similarly to outcome 4, we suppose that a progressive improvement of NPi values during CPR may suggest vitality of the brainstem and oxigenation of the brain.; We want to evaluate possible correlation between changing in NPi trend and neurological outcome with mRS in the survivors patient (ROSC)

Trial Locations

Locations (1)

Agenzia Regionale Emergenza Urgenza - AREU; 🇮🇹 Milano, Italy