Propofol-induced EEG Changes in Hypoxic Brain Injury

Cardiac Arrest Clinical Trial

— PROPEA3  

Official title:

Assessment of Hypoxic Brain Injury by Analyzing Propofol-induced EEG Changes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03485781
• Other study ID #: 302/2016
• Status: Completed
• Start date: October 12, 2017
• Est. completion date: July 10, 2019

Study information

• Verified date: March 2020
• Source: University of Oulu
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: July 10, 2019
• Est. primary completion date: July 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Comatose patients admitted to intensive care after cardiac arrest

Exclusion Criteria:

• Previous neurological disease expected to affect EEG substantially

Related Conditions & MeSH terms

• Brain Diseases
• Brain Injuries
• Brain Ischemia
• Cardiac Arrest
• Hypoxia
• Hypoxia-Ischemia, Brain
• Hypoxic-Ischemic Encephalopathy

Locations

Country	Name	City	State
Finland	Helsinki University Central Hospital	Helsinki
Finland	Oulu University Hospital	Oulu

Sponsors (4)

Lead Sponsor	Collaborator
University of Oulu	Cerenion Oy, Helsinki University Central Hospital, Oulu University Hospital

Country where clinical trial is conducted

Finland, 

References & Publications (1)

Kortelainen J, Väyrynen E, Huuskonen U, Laurila J, Koskenkari J, Backman JT, Alahuhta S, Seppänen 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EEG slow-wave activity	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.	0-48 hours