Cerebral Oxymetry and Neurological Outcome in Therapeutic Hypothermia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-09-30

Study Completion Date

2018-12-31

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

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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.

Conditions

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Hypoxic-Ischemic Encephalopathy Post-Cardiorespiratory Arrest Coma Cardiac Arrest

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Aykut Saritas

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR