Clinical trial NCT05192772: Early Neurological Assessment With Pupillometry in Cardiac Arrest During Resuscitation
Official title: EASY CARE Early Neurological Assessment With Pupillometry in Cardiac Arrest During Resuscitation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiac Arrest
Out-Of-Hospital Cardiac Arrest
Lead sponsor: Societa Italiana Anestesia Analgesia Rianimazione e Terapia Intensiva
Sponsor class: OTHER
Collaborators: name: AREU - Agenzia Regionale Emergenza Urgenza
First posted: 2022-01-14
Enrollment: 214
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all adults present in the Lombardy region at the time of cardiac arrest.

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

Eligibility criteria: 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

Primary outcomes:
measure: Return of spontaneous circulation (ROSC) prediction
timeFrame: Variable because depends on the cardiac resuscitation manoeuvers lasting usually not more than 45 minutes
Secondary outcomes:
measure: Correlation of NPi and end tidal CO2 (ETCO2) and ROSC prediction
timeFrame: Variable because depends on the cardiac resuscitation manoeuvers lasting usually not more than 45 minutes
measure: Correlation between NPi and Neurological Outcome as Modified Rankin Scale (mRS)
timeFrame: 1 month, 6 months, 1 year
measure: Correlation between NPi trend and ROSC
timeFrame: Variable because depends on the cardiac resuscitation manoeuvers lasting usually not more than 45 minutes
measure: Correlation between NPi trend and mRS in ROSC patients
timeFrame: 1 month, 6 months, 1 year
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Agenzia Regionale Emergenza Urgenza - AREU
Study officials:
affiliation: ASST Lariana Ospedale Sant'Anna di Como
name: Simone M Zerbi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Division of Anesthesiology, Intensive Care & emergency Medicine, Università degli studi di Brescia
name: Frank A Rasulo, Prof.
role: STUDY_DIRECTOR
affiliation: AREU - Agenzia Regionale Emergenza Urgenza
name: Marco Botteri, MD
role: STUDY_CHAIR
affiliation: Institute of Anesthesiology and Intensive Care Medicine, Università Cattolica del Sacro Cuore, Roma.
name: Claudio Sandroni, Prof.
role: STUDY_CHAIR
affiliation: Dip. Anestesia, Rianimazione ed Emergenze II, ASST Spedali Civili di Brescia
name: Giovanni Chiarini, MD
role: STUDY_CHAIR
affiliation: UOC Anestesia e Rianimazione Voghera e Oltrepò, ASST Pavia.
name: Maurizio Raimondi, MD
role: STUDY_CHAIR
affiliation: Department of Medicine, Division of Nephrology, EOC, Lugano
name: Antonio Bellasi, phD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.