Propofol-induced EEG Changes in Hypoxic Brain Injury

Completed

• Conditions: Hypoxic-Ischemic Encephalopathy; Cardiac Arrest

• Registration Number: NCT03485781
• Lead Sponsor: University of Oulu

Brief Summary

PROPEA3 is a prospective observational study investigating the recovery of propofol-induced EEG slow-wave activity and its association with neurological outcome after cardiac arrest.

Detailed Description

PROPEA3 is a prospective observational study investigating the recovery of propofol-induced EEG slow-wave activity and its association with neurological outcome after cardiac arrest. Comatose adult patients admitted to intensive care unit (ICU) after cardiac arrest are included. Patients with previous neurological disease expected to affect substantially 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 continuously from the admission to the ICU until 48 hours from the cardiac arrest. EEG slow-wave activity is determined offline by calculating the low-frequency (\<1 Hz) power from the signal. 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: 2017-10-12
• Study First Submitted: 2018-03-26
• Study First Submitted QC: 2018-03-26
• Study First Posted: 2018-04-02
• Primary Completion: 2019-07-10
• Study Completion: 2019-07-10
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-24
• Last Update Posted: 2020-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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	0-48 hours	EEG slow-wave activity defined by the low-frequency (\<1 Hz) signal power calculated continuously from the beginning of EEG measurement until 48 hours from cardiac arrest. The study investigates the association between the slow-wave activity and neurological outcome i.e. Cerebral Performance Category after 6 month follow-up period.

Trial Locations

Locations (2)

Helsinki University Central Hospital; 🇫🇮 Helsinki, Finland

Oulu University Hospital; 🇫🇮 Oulu, Finland