NCT03287401

Prediction of PACU Delirium Using EEG - German Validation Study

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 200 (actual)
• Sponsor: Technical University of Munich · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Delirium

Interventions

Type	Name	Description
DEVICE	Electroencephalography	Patients electroencephalogram will be recorded

Timeline

• Start date: 2017-09-19
• Primary completion: 2019-12-06
• Completion: 2019-12-06
• First posted: 2017-09-19
• Last updated: 2020-01-14

Locations

1 site across 1 country: Germany