EEG Slow Wave Activity in Hypoxic Brain Injury

NCT ID: NCT04506788

Last Updated: 2020-08-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 25 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-06-15
• Study Completion Date: 2017-06-12

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.

Conditions

Hypoxic-Ischemic Encephalopathy; Cardiac Arrest

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Comatose patients admitted to intensive care after cardiac arrest

Exclusion Criteria

• Previous neurological disease expected to affect EEG substantially

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oulu University Hospital

OTHER

Sponsor Role: collaborator

Cerenion Oy

INDUSTRY

Sponsor Role: collaborator

University of Oulu

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jukka Kortelainen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Oulu

Locations

Oulu University Hospital

Oulu, , Finland

Countries

Finland

References

Kortelainen J, Vayrynen 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.

Reference Type: BACKGROUND

PMID: 30788811 (View on PubMed)

Kortelainen J, Vayrynen E, Huuskonen U, Laurila J, Koskenkari J, Backman JT, Alahuhta S, Seppanen 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. doi: 10.1097/ALN.0000000000001385.

Reference Type: BACKGROUND

PMID: 27749312 (View on PubMed)

Other Identifiers

68/2012

Identifier Type: -

Identifier Source: org_study_id