Propofol-induced EEG Changes in Hypoxic Brain Injury

NCT ID: NCT03485781

Last Updated: 2020-03-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 102 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-10-12
• Study Completion Date: 2019-07-10

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.

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

Helsinki University Central 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

Helsinki University Central Hospital

Helsinki, , Finland

Oulu University Hospital

Oulu, , Finland

Countries

Finland

References

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

302/2016

Identifier Type: -

Identifier Source: org_study_id