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CompletedNCT03287401PACUD-EEGUpdated Jan 14, 2020

Prediction of PACU Delirium Using EEG - German Validation Study

An observational study in Delirium, sponsored by Technical University of Munich. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-01-14.

Sponsored by Technical University of Munich · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Delirium

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Keywords

  • EEG
  • PACU Delirium
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All patients above the age of 18 years undergoing general anaesthesia

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • emergency surgery
  • general anaesthesia within 30 days before
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (actual)
Patient registry
No

Groups and cohorts

  • Patients with general anesthesia

    Patients with general anaesthesia are monitored with electroencephalography and the results will be associated with the risk for PACU delirium

    Device: Electroencephalography

Interventions

  • DeviceElectroencephalography

    Patients electroencephalogram will be recorded

05

What researchers measure

Primary outcomes

  1. PACU Delirium

    Detection of delirium in the postoperative anaesthesia care unit using CAM-ICU score

    Time frame: Emergence from anaesthesia until discharge from postoperative anaesthesia care unit (60 minutes)

Secondary outcomes

  1. Pain in the PACU (NRS)

    Pain assessed with numeric rating scale

    Time frame: Emergence from anaesthesia until discharge from postoperative anaesthesia care unit (60 minutes)

  2. Electroencephalography

    Electroencephalography recording

    Time frame: Pre-induction until emergence from anaesthesia (average of 3 hours)

06

Study locations

1 site
  • Klinikum rechts der Isar Dept. of Anesthesiology
    Munich, 81675, Germany
07

References and documents

Publications

  • 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. doi: 10.1001/jama.289.22.2983. PubMed 12799407 ↗
  • Lutz R, Muller C, Dragovic S, Schneider F, Ribbe K, Anders M, Schmid S, Garcia PS, Schneider G, Kreuzer M, Kratzer S. The absence of dominant alpha-oscillatory EEG activity during emergence from delta-dominant anesthesia predicts neurocognitive impairment- results from a prospective observational trial. J Clin Anesth. 2022 Nov;82:110949. doi: 10.1016/j.jclinane.2022.110949. Epub 2022 Aug 29. PubMed 36049381 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03287401
Lead sponsor
Technical University of Munich
Collaborators
Emory University
Responsible party
Sponsor
First posted
Sep 19, 2017
Start date
Sep 19, 2017
Primary completion
Dec 6, 2019
Completion
Dec 6, 2019
Last update
Jan 14, 2020

Study contacts

Sebastian Schmid, MD
principal investigator · Klinikum rechts der Isar - Dept. of Anaesthesiology

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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