Prediction of PACU Delirium Using EEG - German Validation Study

NCT03287401 | Completed

• 1 other identifier: PACUD-EEG
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Delirium

Keywords

EEG; PACU Delirium

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Pain in the PACU (NRS)

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

• Electroencephalography

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

Study Arms (1)

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

Electroencephalography DEVICE

Patients electroencephalogram will be recorded

Patients with general anesthesia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients above the age of 18 years undergoing general anaesthesia

You may qualify if:

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

You may not qualify if:

• emergency surgery
• general anaesthesia within 30 days before

Sponsors & Collaborators

• Technical University of Munich: lead
• Emory University: collaborator

Study Sites (1)

Klinikum rechts der Isar Dept. of Anesthesiology

Munich, 81675, Germany

Location

Related Publications (2)

• 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.

  PMID: 12799407 BACKGROUND

• 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.

  PMID: 36049381 DERIVED

MeSH Terms

Conditions

Delirium

Interventions

Electroencephalography

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Neurological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Study Officials

• Sebastian Schmid, MD

  Klinikum rechts der Isar - Dept. of Anaesthesiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2017
• First Posted: September 19, 2017
• Study Start: September 19, 2017
• Primary Completion: December 6, 2019
• Study Completion: December 6, 2019
• Last Updated: January 14, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)