An observational study in Cardiac Arrest and Out-Of-Hospital Cardiac Arrest, sponsored by Societa Italiana Anestesia Analgesia Rianimazione e Terapia Intensiva. Status unknown at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-10-26.
Sponsored by Societa Italiana Anestesia Analgesia Rianimazione e Terapia Intensiva · Observational
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
all adults present in the Lombardy region at the time of cardiac arrest.
Exclusion Criteria:
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
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).
Time frame: Variable because depends on the cardiac resuscitation manoeuvers lasting usually not more than 45 minutes
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).
Time frame: 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.
Time frame: 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
Time frame: 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)
Time frame: 1 month, 6 months, 1 year
Plan to share: No
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Societa Italiana Anestesia Analgesia Rianimazione e Terapia Intensiva