Prediction of PACU Delirium Using EEG - German Validation Study (PACUD-EEG)

Prediction of Postoperative Anesthesia Care Unit Delirium Using Electroencephalography - German Validation Study

Aim of this observational study is to investigate whether frontal electroencephalogram analysis is able to predict increased risk for PACU delirium.

Study Overview

• Status: Completed
• Conditions: Delirium
• Intervention / Treatment: Device: Electroencephalography

Detailed Description

Delirium in the postoperative anaesthesia care unit (PACU), a special of form of postoperative delirium, is associated with increased hospital stay and an elevated hospital re-admission rate. First studies investigating the patients' electroencephalogram (EEG) on emergence from anaesthesia were able to show that an abrupt change of predominant EEG-rhythm is associated with an increased rate of PACU delirium. Therefore, it seems possible to use frontal EEG in order to identify patients being at elevated risk for PACU delirium.

Aim of this observational study is to validate the results of an international collaboration in a German population of patients undergoing general anaesthesia. EEG in these patients is recorded from start of anaesthesia until emergence. Rate of PACU delirium is assessed using the CAM-ICU score 15 and 60 minutes after emergence in the recovery room.

In a pilot study in 626 patients from 2013 to 2015 in 5 international study centres the rate of PACU delirium was 20%. As it is planned to investigate 5 co-factors using regression analysis 50 cases of delirium will be necessary for a sufficient analysis. Therefore, in total 250 patients will be included.

Due to an additional study centre that included 50 patients enrolment of the german validation group was completed after 200 patients.

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• Germany
  • Munich, Germany, 81675
    • Klinikum rechts der Isar Dept. of Anesthesiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients above the age of 18 years undergoing general anaesthesia

Description

Inclusion Criteria:

• age: 18 years or older
• surgery in general anaesthesia

Exclusion Criteria:

• emergency surgery
• general anaesthesia within 30 days before

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with general anesthesia; Patients with general anaesthesia are monitored with electroencephalography and the results will be associated with the risk for PACU delirium	Device: Electroencephalography; Patients electroencephalogram will be recorded

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PACU Delirium	Detection of delirium in the postoperative anaesthesia care unit using CAM-ICU score	Emergence from anaesthesia until discharge from postoperative anaesthesia care unit (60 minutes)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain in the PACU (NRS)	Pain assessed with numeric rating scale	Emergence from anaesthesia until discharge from postoperative anaesthesia care unit (60 minutes)
Electroencephalography	Electroencephalography recording	Pre-induction until emergence from anaesthesia (average of 3 hours)

Collaborators and Investigators

• Sponsor: Technical University of Munich
• Collaborators: Emory University
• Investigators: Principal Investigator: Sebastian Schmid, MD, Klinikum rechts der Isar - Dept. of Anaesthesiology

Publications and helpful links

General Publications

• Ely EW, Truman B, Shintani A, Thomason JW, Wheeler AP, Gordon S, Francis J, Speroff T, Gautam S, Margolin R, Sessler CN, Dittus RS, Bernard GR. Monitoring sedation status over time in ICU patients: reliability and validity of the Richmond Agitation-Sedation Scale (RASS). JAMA. 2003 Jun 11;289(22):2983-91. doi: 10.1001/jama.289.22.2983.
• Lutz R, Muller C, Dragovic S, Schneider F, Ribbe K, Anders M, Schmid S, Garcia PS, Schneider G, Kreuzer M, Kratzer S. The absence of dominant alpha-oscillatory EEG activity during emergence from delta-dominant anesthesia predicts neurocognitive impairment- results from a prospective observational trial. J Clin Anesth. 2022 Nov;82:110949. doi: 10.1016/j.jclinane.2022.110949. Epub 2022 Aug 29.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 19, 2017
• Primary Completion (ACTUAL): December 6, 2019
• Study Completion (ACTUAL): December 6, 2019

Study Registration Dates

• First Submitted: September 15, 2017
• First Submitted That Met QC Criteria: September 18, 2017
• First Posted (ACTUAL): September 19, 2017

Study Record Updates

• Last Update Posted (ACTUAL): January 14, 2020
• Last Update Submitted That Met QC Criteria: January 10, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: EEG; PACU Delirium
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium
• Other Study ID Numbers: PACUD-EEG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No