Early Neurological Assessment With Pupillometry in Cardiac Arrest During Resuscitation

NCT05192772 | Unknown

• 1 other identifier: 2494
• Study Type: observational
• Target: 214
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Arrest; Out-Of-Hospital Cardiac Arrest

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

• Correlation between NPi and Neurological Outcome as Modified Rankin Scale (mRS)

  1 month, 6 months, 1 year

• Correlation between NPi trend and 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

  1 month, 6 months, 1 year

Interventions

NPi200 DEVICE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Societa Italiana Anestesia Analgesia Rianimazione e Terapia Intensiva: lead
• AREU - Agenzia Regionale Emergenza Urgenza: collaborator

Study Sites (1)

Agenzia Regionale Emergenza Urgenza - AREU

Milan, 20124, Italy

RECRUITING

Related Publications (5)

• 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.

  PMID: 30478620 BACKGROUND

• 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.

  PMID: 31069659 BACKGROUND

• 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.

  PMID: 32066312 BACKGROUND

• 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.

  PMID: 30599180 BACKGROUND

• Zerbi SM, Sandroni C, Botteri M, Bellasi A, Latronico N, Rasulo F. Early Neurological ASsessment with pupillometrY during Cardiac Arrest REsuscitation (EASY-CARE): protocol for an observational multicentre prospective study. BMJ Open. 2022 Dec 20;12(12):e063633. doi: 10.1136/bmjopen-2022-063633.

  PMID: 36600432 DERIVED

MeSH Terms

Conditions

Heart Arrest; Out-of-Hospital Cardiac Arrest

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Simone M Zerbi, MD

  ASST Lariana Ospedale Sant'Anna di Como

  PRINCIPAL INVESTIGATOR

• Frank A Rasulo, Prof.

  Division of Anesthesiology, Intensive Care & emergency Medicine, Università degli studi di Brescia

  STUDY DIRECTOR

• 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

  STUDY CHAIR

Central Study Contacts

Simone M Zerbi, MD

CONTACT

003903155859742; smzerbi@gmail.com

Frank A. Rasulo, Prof.

CONTACT

frank.rasulo@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 25, 2021
• First Posted: January 14, 2022
• Study Start: December 1, 2022
• Primary Completion: July 1, 2023
• Study Completion: December 15, 2023
• Last Updated: October 26, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)