Clinical trial NCT04506788: EEG Slow Wave Activity in Hypoxic Brain Injury
Official title: Assessment of EEG Slow Wave Activity in Comatose Cardiac Arrest Survivors Under Propofol Anesthesia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypoxic-Ischemic Encephalopathy
Cardiac Arrest
Keywords: EEG
Intensive Care
Propofol
Lead sponsor: University of Oulu
Sponsor class: OTHER
Collaborators: name: Oulu University Hospital
name: Cerenion Oy
First posted: 2020-08-10
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All eligible patients admitted to intensive care in the study units.

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.

Eligibility criteria: Inclusion Criteria:

* Comatose patients admitted to intensive care after cardiac arrest

Exclusion Criteria:

* Previous neurological disease expected to affect EEG substantially

Primary outcomes:
measure: EEG slow wave activity
timeFrame: 0-72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Oulu
country: Finland
facility: Oulu University Hospital
Study officials:
affiliation: University of Oulu
name: Jukka Kortelainen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.