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| Name | Class |
|---|---|
| AREU - Agenzia Regionale Emergenza Urgenza | UNKNOWN |
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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.
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:
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
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| 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 |
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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all adults present in the Lombardy region at the time of cardiac arrest.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Simone M Zerbi, MD | Contact | 003903155859742 | smzerbi@gmail.com | |
| Frank A. Rasulo, Prof. | Contact | frank.rasulo@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Agenzia Regionale Emergenza Urgenza - AREU | Recruiting | Milan | 20124 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30478620 | Background | 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. | |
| 31069659 |
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| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| D058687 | Out-of-Hospital Cardiac Arrest |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| 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 |
| 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 |
| 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. |
| 32066312 | 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. |
| 30599180 | 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. |
| 36600432 | Derived | 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. |