Cerebral Oxymetry and Neurological Outcome in Therapeutic Hypothermia

Completed

• Conditions: Cardiac Arrest; Hypoxic-Ischemic Encephalopathy; Post-Cardiorespiratory Arrest Coma

• Registration Number: NCT03024021
• Lead Sponsor: Tepecik Training and Research Hospital

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.

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2016-12-21
• Study First Submitted QC: 2017-01-17
• Study First Posted: 2017-01-18
• Primary Completion: 2018-09
• Study Completion: 2018-12
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-09
• Last Update Posted: 2020-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

Exclusion Criteria

• Patients under 18 years
• Patients unsuitable for therapeutic hypothermia

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Measure of cerebral oximetry	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 Outcome Measures

Name	Time	Method
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	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).

Trial Locations

Locations (1)

Tepecik Research and Training Hospital; 🇹🇷 Izmir, Konak, Turkey