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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiac Arrest; Out-Of-Hospital Cardiac Arrest
• Intervention / Treatment: Device: NPi200

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 Type: Observational
• Enrollment (Anticipated): 214

Contacts and Locations

• Study Contact: Name: Simone M Zerbi, MD; Phone Number: 003903155859742; Email: smzerbi@gmail.com
• Study Contact Backup: Name: Frank A. Rasulo, Prof.; Email: frank.rasulo@gmail.com

Study Locations

• Italy
  • Milano, Italy, 20124
    • Recruiting
    • Agenzia Regionale Emergenza Urgenza - AREU
    • Contact: Simone M Zerbi, MD; Phone Number: +390315859742; Email: s.zerbi@areu.lombardia.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

all adults present in the Lombardy region at the time of cardiac arrest.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Return of spontaneous circulation (ROSC) prediction	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).	Variable because depends on the cardiac resuscitation manoeuvers lasting usually not more than 45 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation of NPi and end tidal CO2 (ETCO2) and ROSC prediction	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).	Variable because depends on the cardiac resuscitation manoeuvers lasting usually not more than 45 minutes
Correlation between NPi and Neurological Outcome as Modified Rankin Scale (mRS)	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.	1 month, 6 months, 1 year
Correlation between NPi trend and ROSC	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	Variable because depends on the cardiac resuscitation manoeuvers lasting usually not more than 45 minutes
Correlation between NPi trend and mRS in ROSC patients	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)	1 month, 6 months, 1 year

Collaborators and Investigators

• Sponsor: Societa Italiana Anestesia Analgesia Rianimazione e Terapia Intensiva
• Collaborators: AREU - Agenzia Regionale Emergenza Urgenza
• Investigators: Principal Investigator: Simone M Zerbi, MD, ASST Lariana Ospedale Sant'Anna di Como; Study Director: Frank A Rasulo, Prof., Division of Anesthesiology, Intensive Care & emergency Medicine, Università degli studi di Brescia; Study Chair: Marco Botteri, MD, AREU - Agenzia Regionale Emergenza Urgenza; Study Chair: Claudio Sandroni, Prof., Institute of Anesthesiology and Intensive Care Medicine, Università Cattolica del Sacro Cuore, Roma.; Study Chair: Giovanni Chiarini, MD, Dip. Anestesia, Rianimazione ed Emergenze II, ASST Spedali Civili di Brescia; Study Chair: Maurizio Raimondi, MD, UOC Anestesia e Rianimazione Voghera e Oltrepò, ASST Pavia.; Study Chair: Antonio Bellasi, phD, Department of Medicine, Division of Nephrology, EOC, Lugano

Publications and helpful links

General Publications

• Oddo M, Sandroni C, Citerio G, Miroz JP, Horn J, Rundgren M, Cariou A, Payen JF, Storm C, Stammet P, Taccone FS. Quantitative versus standard pupillary light reflex for early prognostication in comatose cardiac arrest patients: an international prospective multicenter double-blinded study. Intensive Care Med. 2018 Dec;44(12):2102-2111. doi: 10.1007/s00134-018-5448-6. Epub 2018 Nov 26.
• Riker RR, Sawyer ME, Fischman VG, May T, Lord C, Eldridge A, Seder DB. Neurological Pupil Index and Pupillary Light Reflex by Pupillometry Predict Outcome Early After Cardiac Arrest. Neurocrit Care. 2020 Feb;32(1):152-161. doi: 10.1007/s12028-019-00717-4.
• Achamallah N, Fried J, Love R, Matusov Y, Sharma R. Pupillary Light Reflex Is Not Abolished by Epinephrine and Atropine Given During Advanced Cardiac Life Support in Patients Who Achieve Return of Spontaneous Circulation. J Intensive Care Med. 2021 Apr;36(4):459-465. doi: 10.1177/0885066620906802. Epub 2020 Feb 18.
• Lee HJ, Shin J, Hong KJ, Jung JH, Lee SJ, Jung E, You KM, Kim TH. A feasibility study for the continuous measurement of pupillary response using the pupillography during CPR in out-of-hospital cardiac arrest patients. Resuscitation. 2019 Feb;135:80-87. doi: 10.1016/j.resuscitation.2018.11.016. Epub 2018 Dec 30.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): December 1, 2022
• Primary Completion (ANTICIPATED): July 1, 2023
• Study Completion (ANTICIPATED): December 15, 2023

Study Registration Dates

• First Submitted: November 25, 2021
• First Submitted That Met QC Criteria: December 30, 2021
• First Posted (ACTUAL): January 14, 2022

Study Record Updates

• Last Update Posted (ACTUAL): October 26, 2022
• Last Update Submitted That Met QC Criteria: October 25, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Arrest; Out-of-Hospital Cardiac Arrest
• Other Study ID Numbers: 2494

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No