Prediction of PACU Delirium Using EEG - German Validation Study

Delirium Clinical Trial

— PACUD-EEG  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03287401
• Other study ID #: PACUD-EEG
• Status: Completed
• Start date: September 19, 2017
• Est. completion date: December 6, 2019

Study information

• Verified date: January 2020
• Source: Technische Universität München
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 6, 2019
• Est. primary completion date: December 6, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• age: 18 years or older

• surgery in general anaesthesia

Exclusion Criteria:

• emergency surgery

• general anaesthesia within 30 days before

Related Conditions & MeSH terms

• Delirium

Intervention

Device:
• Electroencephalography
Patients electroencephalogram will be recorded

Locations

Country	Name	City	State
Germany	Klinikum rechts der Isar Dept. of Anesthesiology	Munich

Sponsors (2)

Lead Sponsor	Collaborator
Technische Universität München	Emory University

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. — View Citation

Outcome

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