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Clinical Trials/NCT03024021
NCT03024021
Completed
Not Applicable

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

Tepecik Training and Research Hospital1 site in 1 country100 target enrollmentSeptember 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hypoxic-Ischemic Encephalopathy
Sponsor
Tepecik Training and Research Hospital
Enrollment
100
Locations
1
Primary Endpoint
Measure of cerebral oximetry
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
September 2016
End Date
December 2018
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Tepecik Training and Research Hospital
Responsible Party
Principal Investigator
Principal Investigator

Aykut Saritas

principal investigator

Tepecik Training and Research Hospital

Eligibility Criteria

Inclusion Criteria

  • Patients at least 18 years old
  • Patients undergoing therapeutic hypothermia

Exclusion Criteria

  • Patients under 18 years
  • Patients unsuitable for therapeutic hypothermia

Outcomes

Primary Outcomes

Measure of cerebral oximetry

Time Frame: 8 times during the first 48 hours of hospitalization

During the first 48 hours of hospitalization, we will collect the cerebral oximetry values in the two cerebral. hemispheres.

Secondary Outcomes

  • The cerebral oximetry values (average of the two hemispheres) will be compared between patients with good and poor neurological outcome according with CPC score(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)

Study Sites (1)

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