Non-invasive Neurological Evaluation During CPR

Study Overview
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Brief Summary
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Cardiac arrest remains a leading cause of death, currently affecting >250,000 Europeans outside the hospital each year. Manual cardiopulmonary resuscitation (CPR) provides between 15 to 30 % of normal blood flow to the heart and brain. For out-of-hospital cardiac arrest, the return of spontaneous circulation (ROSC) is possible only for 20-40% of patients with trained resuscitation teams. However, only 5-10% of patients will survive with good neurological status. A good quality CPR, a short time before initiation of the resuscitation and a short delay before the first defibrillation have been associated with improved neurological outcome. Unfortunately it is currently impossible to obtain reliable information on the quality of the perfusion and oxygenation of organs during CPR. The current monitoring during CPR is limited to heart rhythm analysis, pulse rate evaluation and end tidal CO2 (EtCO2). The last one is the only parameter which have been linked with probability of ROSC and its value gives no indication of the long-term prognosis nor the neurological status. Cerebral spectroscopy (near-infrared spectroscopy - NIRS) allows to measure with a noninvasive method the local oxygen saturation of the prefrontal cortex (rSO2), reflecting the balance between need and supply of brain oxygenation. This technique has been recently used in cardiac arrest showing a possible association between rSO2 measured during CPR and the occurrence of ROSC or survival. The quantitative measurement of the pupillary light reaction has been described to predict neurological outcome in the hospital for patient successfully reanimated after out-of-hospital cardiac arrest (OHCA). Recently, a feasibility study has shown that its use was also possible during CPR in the pre-hospital setting. The investigators aim to study a composite prognostic factor combining quantitative rSO2 and automated pupillometry measured during CPR. The investigators hypothesized that the rate of survival with good neurologic outcome at 30 days will be lower in patients with rSO2 <30% for more than 5 min and an absent pupillary reflex more than 5 min or decreasing during CPR .

Official Title
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Non-invasive Neurological Evaluation During Cardiopulmonary Resuscitation for Out of Hospital Cardiac Arrest Patients Neuro-E-CPR Study

Conditions
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Cardiac Arrest

Intervention / Treatment
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* Device: Cerebral spectroscopy
* Device: Pupillometry


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All adults with nontraumatic, out-of-hospital cardiac arrest Exclusion Criteria: Traumatic cardiac arrest Patients who had achieved ROSC before inclusion patients with a do-not-attempt resuscitation order Patients < 18 years old Subjects known to be pregnant or breastfeeding

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cerebral spectroscopy + pupillometry<br>During CPR, rSO2 will be monitored continuously as well as quantitative measurements of the pupillary light reaction every 5 minutes. | Device: Cerebral spectroscopy<br>* Cerebral spectroscopy (near-infrared spectroscopy - NIRS) allows to measure with a noninvasive method the local oxygen saturation of the prefrontal cortex (rSO2), reflecting the balance between need and supply of brain oxygenation.<br>* Other names: near-infrared spectroscopy - NIRS;Device: Pupillometry<br>* The quantitative measurement of the pupillary light reaction has been described to predict neurological outcome<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival status at hospital admission | Alive patients at hospital admission | hospital admission - Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurologic outcome, based on Cerebral Performance Category (CPC) score: CPC 1 or 2 | As measured by using the Cerebral Performance Category (CPC) score: CPC 1 (good cerebral performance) or CPC 2 (moderate cerebral disability) | Day 30 | 
| Survival status at hospital discharge | Alive patients at hospital discharge | up to 30 days if still hospitalized | 
| Survival status at Day 30 | Vital status at 30 days | Day 30 | 
| Neurologic outcome, based on CPC score at hospital discharge | As measured by using the Cerebral Performance Category (CPC) score: CPC 1 (good cerebral performance), CPC 2 (moderate cerebral disability), CPC 3 (severe cerebral disablity), CPC 4 (coma or vegetative state) or CPC 5 (brain death) | up to 30 days if still hospitalized | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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automated infrared pupillometry, cardiac arrest, near-infrared spectroscopy, prognostication