Cerebral Oxymetry and Neurological Outcome in Therapeutic Hypothermia

Study Overview
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Brief Summary
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This study is designed to assess the effect of cerebral oxygen saturation as an early predictor of neurological outcomes in patients undergoing therapeutic hypothermia after cardiac arrest

Detailed Description
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Our study is planned as a prospective observational study. Patients undergoing therapeutic hypothermia in our intensive care unit after cardiac arrest will be enrolled. Each patient's cerebral oxygenation will be monitored with near-infrared spectroscopy (NIRS) in every 6 hours during our 24 hour lasting hypothermia period. Afterwards, patients will be monitorised in every 6 hours during the first day of hypothermia and than the mean values of daily cerebral oxygen values will be noted in the third, fourth and fifth days of nomothermia. Regional oxygen saturation (rSO2) will be noted from left and right probes. Full Outline of Unresponsiveness (FOUR) Score, Glasgow Coma Score (GCS) and cerebral performance category scale (CPC) will be noted at the beginning of therapeutic hypothermia and each day during normothermia, day 21 and the day of discharge from ICU.

Official Title
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The Effect of Cerebral Oxymetry in Determining Neurological Outcome in Patients Treated With Therapeutic Hypothermia

Conditions
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Hypoxic-Ischemic Encephalopathy, Post-Cardiorespiratory Arrest Coma, Cardiac Arrest

Intervention / Treatment
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* Device: Near-infrared spectroscopy (NIRS) (INVOS®, Covidien)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients at least 18 years old Patients undergoing therapeutic hypothermia Exclusion Criteria: Patients under 18 years Patients unsuitable for therapeutic hypothermia

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

| Intervention/Treatment |
| --- |
|Device: Near-infrared spectroscopy (NIRS) (INVOS®, Covidien)|As we start the targeted temperature management protocol (24 hours of hypothermia adjusted to 33-36 C and afterwards up to five days of normothermia [36.5 C]) NIRS sensor pads will be placed over the right and left frontal area. Regional cerebral oxygen values will be continuously recorded at the NIRS monitor. Tests to assess neurological outcome will be performed. Patients will be assessed in terms of neurological performance tests and regional cerebral oxygen.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of cerebral oximetry | During the first 48 hours of hospitalization, we will collect the cerebral oximetry values in the two cerebral. hemispheres. | 8 times during the first 48 hours of hospitalization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The cerebral oximetry values (average of the two hemispheres) will be compared between patients with good and poor neurological outcome according with CPC score | The cerebral oximetry values (average of the two hemispheres) will be compared between patients with good and poor neurological outcome according to the CPC score. CPC 1: Conscious and alert with normal function or only slight disability CPC 2: Conscious and alert with moderate disability CPC 3: Conscious with severe disability CPC 4: Comatose or persistent vegetative state CPC 5: death. CPC will be evaluated at the time of admission to intensive care unit and day 21.CPC score (CPC = 1 become good score - 2 and bad become CPC = 3-5). | Participants will be followed for 8 times during the first 48 hours of hospitalization, the third day, fourth day and fifth day and the duration of hospital stay, an expected average of 2-4 weeks and a 12 month follow up will be performed | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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therapeutic hypothermia, targeted temperature management, neurological outcome, post-cardiac arrest syndrome