EEG Slow Wave Activity in Hypoxic Brain Injury

Cardiac Arrest Clinical Trial

— BrainICU  

Official title:

Assessment of EEG Slow Wave Activity in Comatose Cardiac Arrest Survivors Under Propofol Anesthesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04506788
• Other study ID #: 68/2012
• Status: Completed
• Start date: June 15, 2015
• Est. completion date: June 12, 2017

Study information

• Verified date: August 2020
• Source: University of Oulu
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

BrainICU is a prospective observational study investigating the EEG slow wave activity in comatose cardiac arrest survivors under propofol anesthesia and its association with neurological outcome.

Description:

BrainICU is a prospective observational study investigating the EEG slow wave activity in comatose cardiac arrest survivors under propofol anesthesia and its association with neurological outcome. Comatose adult patients admitted to intensive care unit (ICU) after cardiac arrest are included. Patients with previous neurological disease expected to affect substantially the EEG are excluded. The patients' relatives are asked for an informed written consent to participate. In the intensive care, the patients are sedated using continuous infusion of propofol while receiving temperature management/hypothermia treatment following the ICUs' common practice. EEG is recorded within the first 24h after ICU admission. If possible, the recording is repeated on the second and third day i.e. 48h and 72h after ICU admission, respectively. To induce the maximum effect of propofol on EEG, additional boluses of propofol during the EEG recording may be given until the burst suppression level is reached. Slow wave activity is calculated offline from the EEG recordings. The neurological recovery of the patients is defined 6 months after cardiac arrest from patient documents and/or by phone call to the patient/ relative using Cerebral Performance Category. After the follow-up period patient or the relative is also asked to fill a survey (SF-36) to estimate the health and quality of life.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: June 12, 2017
• Est. primary completion date: June 12, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Comatose patients admitted to intensive care after cardiac arrest

Exclusion Criteria:

• Previous neurological disease expected to affect EEG substantially

Related Conditions & MeSH terms

• Brain Diseases
• Brain Ischemia
• Cardiac Arrest
• Heart Arrest
• Hypoxia
• Hypoxia-Ischemia, Brain
• Hypoxic-Ischemic Encephalopathy

Locations

Country	Name	City	State
Finland	Oulu University Hospital	Oulu

Sponsors (3)

Lead Sponsor	Collaborator
University of Oulu	Cerenion Oy, Oulu University Hospital

Country where clinical trial is conducted

Finland, 

References & Publications (2)

Kortelainen J, Väyrynen E, Huuskonen U, Laurila J, Koskenkari J, Backman JT, Alahuhta S, Seppänen T, Ala-Kokko T. Pilot Study of Propofol-induced Slow Waves as a Pharmacologic Test for Brain Dysfunction after Brain Injury. Anesthesiology. 2017 Jan;126(1):94-103. — View Citation

Kortelainen J, Väyrynen E, Juuso I, Laurila J, Koskenkari J, Ala-Kokko T. Forehead electrodes sufficiently detect propofol-induced slow waves for the assessment of brain function after cardiac arrest. J Clin Monit Comput. 2020 Feb;34(1):105-110. doi: 10.1007/s10877-019-00282-3. Epub 2019 Feb 20. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EEG slow wave activity	EEG slow-wave activity determined from the low-frequency (<1 Hz) signal component calculated from the EEG recordings made within 24 hours from ICU admission and repeated, if possible, at 48 hours and 72 hours.	0-72 hours