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Completed

NCT Number: NCT03287401

Prediction of PACU Delirium Using EEG - German Validation Study

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Klinikum rechts der Isar Dept. of Anesthesiology

Munich, 81675, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • emergency surgery
  • general anaesthesia within 30 days before

Treatment and study plan

Electroencephalography

Device

Patients electroencephalogram will be recorded

Primary outcomes

  1. 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

  1. Pain in the PACU (NRS)

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

    Pain assessed with numeric rating scale

  2. Electroencephalography

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

    Electroencephalography recording

Sponsors and collaborators

Lead sponsor

Technical University of Munich

Other

Collaborators

  • Emory University

Registry information

Official study title

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

Acronym: PACUD-EEG

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Sep 19, 2017
Registry last updated
Jan 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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