Cerebral Oxymetry and Neurological Outcome in Therapeutic Hypothermia

Cardiac Arrest Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03024021
• Other study ID #: 29/3
• Status: Completed
• Start date: September 2016
• Est. completion date: December 2018

Study information

• Verified date: March 2020
• Source: Tepecik Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients at least 18 years old

• Patients undergoing therapeutic hypothermia

Exclusion Criteria:

• Patients under 18 years

• Patients unsuitable for therapeutic hypothermia

Related Conditions & MeSH terms

• Brain Diseases
• Brain Ischemia
• Cardiac Arrest
• Heart Arrest
• Hypothermia
• Hypoxia-Ischemia, Brain
• Hypoxic-Ischemic Encephalopathy
• Post-Cardiorespiratory Arrest Coma

Intervention

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.

Locations

Country	Name	City	State
Turkey	Tepecik Research and Training Hospital	Izmir	Konak

Sponsors (1)

Lead Sponsor	Collaborator
Tepecik Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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) — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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