Early Neurological ASsessment with pupillometrY during Cardiac Arrest REsuscitation (EASY-CARE): protocol for an observational multicentre prospective study

Introduction: Out-of-hospital cardiac arrest is burdened with a high rate of ineffective resuscitation and poor neurological outcome among survivors. To date, there are few perfusion assessment tools during cardiopulmonary resuscitation and none of them provide reliable data. Despite the lack of information, physicians must decide whether to extend or terminate resuscitation efforts.

Method and analysis: This is a multicentre prospective, observational cohort study, involving adult patients, victims of unexpected out-of-hospital cardiac arrest. Early Neurological ASsessment with pupillometrY during Cardiac Arrest Resuscitation aims to primarily describe the reliability of quantitative pupillometry through use of the Neurological Pupillary Index (NPi) during the manoeuvre of cardiopulmonary resuscitation, as a predictor of the return of spontaneous circulation. The second objective is to seek and describe the association between the NPi and neurological outcome in the surviving cohort. Patients will be excluded if they are less than 18 years of age, have sustained traumatic brain injury, cerebrovascular emergencies, direct injury to the eyes or have pupil anomalies. Neurological outcome will be collected at intensive care unit discharge, at 30 days, 6 months and at 1 year. The Glasgow Coma Scale (GCS) will be used in the emergency department; modified Rankin Score will be adopted for neurological assessment; biomarkers and neurophysiology exams will be collected as well.

Ethics and dissemination: The study has been approved by Ethics Committee of Milano. Local committee acceptance is required for each of the centres involved in the clinical and follow-up data collection. Data will be disseminated to the scientific community through original articles submitted to peer-reviewed journals and abstracts to conferences.

Trial registration number: NCT05192772.