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Prediction of PACU Delirium Using EEG - German Validation Study

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03287401
Acronym
PACUD-EEG
Enrollment
200
Registered
2017-09-19
Start date
2017-09-19
Completion date
2019-12-06
Last updated
2020-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delirium

Keywords

EEG, PACU Delirium

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.

Interventions

DEVICEElectroencephalography

Patients electroencephalogram will be recorded

Sponsors

Emory University
CollaboratorOTHER
Technical University of Munich
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* emergency surgery * general anaesthesia within 30 days before

Design outcomes

Primary

MeasureTime frameDescription
PACU DeliriumEmergence 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

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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026