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Clinical Trials/NCT03287401
NCT03287401
Completed
Not Applicable

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

Technical University of Munich1 site in 1 country200 target enrollmentSeptember 19, 2017
ConditionsDelirium

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Delirium
Sponsor
Technical University of Munich
Enrollment
200
Locations
1
Primary Endpoint
PACU Delirium
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 19, 2017
End Date
December 6, 2019
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Technical University of Munich
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • emergency surgery
  • general anaesthesia within 30 days before

Outcomes

Primary Outcomes

PACU Delirium

Time Frame: 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 Outcomes

  • Electroencephalography(Pre-induction until emergence from anaesthesia (average of 3 hours))
  • Pain in the PACU (NRS)(Emergence from anaesthesia until discharge from postoperative anaesthesia care unit (60 minutes))

Study Sites (1)

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