Prediction of PACU Delirium Using EEG - German Validation Study

NCT ID: NCT03287401

Last Updated: 2020-01-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-09-19
• Study Completion Date: 2019-12-06

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.

Conditions

Delirium

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients with general anesthesia

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

Electroencephalography

Intervention Type: DEVICE

Patients electroencephalogram will be recorded

Interventions

Electroencephalography

Patients electroencephalogram will be recorded

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• emergency surgery
• general anaesthesia within 30 days before

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Emory University

OTHER

Sponsor Role: collaborator

Technical University of Munich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sebastian Schmid, MD

Role: PRINCIPAL_INVESTIGATOR

Klinikum rechts der Isar - Dept. of Anaesthesiology

Locations

Klinikum rechts der Isar Dept. of Anesthesiology

Munich, , Germany

Countries

Germany

References

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.

Reference Type: BACKGROUND

PMID: 12799407 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 36049381 (View on PubMed)

Other Identifiers

PACUD-EEG

Identifier Type: -

Identifier Source: org_study_id