Prediction of PACU Delirium Using EEG - German Validation Study

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

Detailed Description
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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.

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

Conditions
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Delirium

Intervention / Treatment
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* Device: Electroencephalography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age: 18 years or older surgery in general anaesthesia Exclusion Criteria: emergency surgery general anaesthesia within 30 days before

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with general anesthesia<br>Patients with general anaesthesia are monitored with electroencephalography and the results will be associated with the risk for PACU delirium | Device: Electroencephalography<br>* Patients electroencephalogram will be recorded<br>|

What is the study measuring?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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EEG, PACU Delirium