Prediction of PACU Delirium Using EEG - German Validation Study

Completed

• Conditions: Delirium
• Interventions: Device: Electroencephalography

• Registration Number: NCT03287401
• Lead Sponsor: Technical University of Munich

Brief Summary

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

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 Timeline

• Study First Submitted: 2017-09-15
• Study First Submitted QC: 2017-09-18
• Study Start: 2017-09-19
• Study First Posted: 2017-09-19
• Primary Completion: 2019-12-06
• Study Completion: 2019-12-06
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-10
• Last Update Posted: 2020-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

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

Exclusion Criteria

• emergency surgery
• general anaesthesia within 30 days before

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with general anesthesia	Electroencephalography	Patients with general anaesthesia are monitored with electroencephalography and the results will be associated with the risk for PACU delirium

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Klinikum rechts der Isar Dept. of Anesthesiology; 🇩🇪 Munich, Germany