Cerebral Oxymetry and Neurological Outcome in Therapeutic Hypothermia

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

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

Study Overview

• Status: Completed
• Conditions: Cardiac Arrest; Hypoxic-Ischemic Encephalopathy; Post-Cardiorespiratory Arrest Coma
• Intervention / Treatment: Device: Near-infrared spectroscopy (NIRS) (INVOS®, Covidien)

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 Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Turkey
  • Konak
    • Izmir, Konak, Turkey, 35110
      • Tepecik Research and Training Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing therapeutic hypothermia after cardiac arrest in a tertiary intensive care unit

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Patients under 18 years
• Patients unsuitable for therapeutic hypothermia

Study Plan

How is the study designed?

What is the study measuring?

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

Other 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 Four score	The cerebral oximetry values (average of the two hemispheres) will be compared between patients with good and poor neurological outcome according to the Fourscore (Full Outline of UnResponsiveness):It evaluates four functional categories: eye response, motor response, brainstem reflexes, and respiration pattern (including mechanical ventilation). All the four categories are scored from 0 to 4 points, with 4 representing normal, and 0 indicating no function.	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

Collaborators and Investigators

• Sponsor: Tepecik Training and Research Hospital
• Investigators: Study Director: Aykut Saritas, Tepecik Research and Training Hospital; Study Chair: Burcu Acar Cinleti, suat seren research and training hospital; Study Chair: Ciler Zincircioglu, Tepecik Research and Training Hospital; Study Chair: İsil Kose, Tepecik Research and Training Hospital; Study Chair: Ugur Uzun, Tepecik Research and Training Hospital; Study Chair: Nimet Senoglu, Tepecik Research and Training Hospital

Publications and helpful links

General Publications

• Storm C, Leithner C, Krannich A, Wutzler A, Ploner CJ, Trenkmann L, von Rheinbarben S, Schroeder T, Luckenbach F, Nee J. Regional cerebral oxygen saturation after cardiac arrest in 60 patients--a prospective outcome study. Resuscitation. 2014 Aug;85(8):1037-41. doi: 10.1016/j.resuscitation.2014.04.021. Epub 2014 Apr 30.
• Genbrugge C, Eertmans W, Meex I, Van Kerrebroeck M, Daems N, Creemers A, Jans F, Boer W, Dens J, De Deyne C. What is the value of regional cerebral saturation in post-cardiac arrest patients? A prospective observational study. Crit Care. 2016 Oct 13;20(1):327. doi: 10.1186/s13054-016-1509-9.
• Nishiyama K, Ito N, Orita T, Hayashida K, Arimoto H, Beppu S, Abe M, Unoki T, Endo T, Murai A, Hatada T, Yamada N, Mizobuchi M, Himeno H, Okuchi K, Yasuda H, Mochizuki T, Shiga K, Kikuchi M, Tsujimura Y, Hatanaka T, Nagao K; J-POP Registry Investigators. Regional cerebral oxygen saturation monitoring for predicting interventional outcomes in patients following out-of-hospital cardiac arrest of presumed cardiac cause: A prospective, observational, multicentre study. Resuscitation. 2015 Nov;96:135-41. doi: 10.1016/j.resuscitation.2015.07.049. Epub 2015 Aug 17.

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (ACTUAL): September 1, 2018
• Study Completion (ACTUAL): December 1, 2018

Study Registration Dates

• First Submitted: December 21, 2016
• First Submitted That Met QC Criteria: January 17, 2017
• First Posted (ESTIMATE): January 18, 2017

Study Record Updates

• Last Update Posted (ACTUAL): March 10, 2020
• Last Update Submitted That Met QC Criteria: March 9, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: neurological outcome; therapeutic hypothermia; targeted temperature management; post-cardiac arrest syndrome
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Central Nervous System Diseases; Nervous System Diseases; Signs and Symptoms, Respiratory; Body Temperature Changes; Hypoxia; Hypoxia, Brain; Brain Ischemia; Brain Diseases; Heart Arrest; Hypothermia; Hypoxia-Ischemia, Brain
• Other Study ID Numbers: 29/3