EEG Slow Wave Activity in Hypoxic Brain Injury

Completed

• Conditions: Hypoxic-Ischemic Encephalopathy; Cardiac Arrest

• Registration Number: NCT04506788
• Lead Sponsor: University of Oulu

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2015-06-15
• Primary Completion: 2017-06-12
• Study Completion: 2017-06-12
• Status Verified: 2020-08
• Study First Submitted: 2020-08-03
• Study First Submitted QC: 2020-08-06
• Last Update Submitted: 2020-08-06
• Study First Posted: 2020-08-10
• Last Update Posted: 2020-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• Comatose patients admitted to intensive care after cardiac arrest

Exclusion Criteria

• Previous neurological disease expected to affect EEG substantially

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
EEG slow wave activity	0-72 hours	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.

Trial Locations

Locations (1)

Oulu University Hospital; 🇫🇮 Oulu, Finland