EEG Spectrogram, Brain Vulnerability and POD

NCT05368272 | Completed

• 1 other identifier: 21074
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

An assessment of difference in prespecified processed electroencephalography variables between cognitively intact older surgical patients who develop postoperative delirium compared to those who do not develop postoperative delirium

Conditions

Postoperative Delirium

Keywords

processed EEG; Postoperative vulnerability; Older people; Brain vulnerability

Outcome Measures

Primary Outcomes (1)

• Feasibility of acquiring frontal and posterior EEG data from the Narcotrend monitor during the preoperative and intraoperative period

  Feasibility will be assessed by the ability to get preoperative and intraoperative epochs of EEG that clearly demonstrates the different brain wave bands (alpha, theta and delta)

  Approximately 1 - 2 hours per participant

Secondary Outcomes (3)

• Preoperative brain wave differences

  Approximately 10 minutes per participant

• Change in brain wave power due to induction of anaesthesia

  Approximately 1 hour per particpant

• Intraoperative brain wave patterns

  Duration of surgery or 2 hours (shortest option)

Interventions

Processed electroencephalography OTHER

Acquisition of raw EEG data from processed EEG monitor. Analysis of data acquired for prespecified bandwidth properties

Postoperative delirium assessment OTHER

Twice daily assessment for the incidence of postoperative delirium using validated tool (questionnaire)

Eligibility Criteria

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

Study Population

Older people scheduled for elective major surgery at a large teaching hospital

You may qualify if:

• ≥ 65 years old
• Elective, moderate/major, non-neuro, non-cardiac surgery
• Ability to give informed consent

You may not qualify if:

• Preoperative cognitive impairment
• Current systemic infection
• Current use of medication that may modify EEG
• History of neurosurgery/significant head trauma
• Presence of neurological diseases including overt stroke, dementia, epilepsy, multiple sclerosis, Parkinson's disease, intracranial tumours and other significant neurologic disorders
• Current significant psychiatric conditions such as severe depression.
• Palliative surgery

Sponsors & Collaborators

• University of Nottingham: lead

Study Sites (1)

Queen's Medical Centre

Nottingham, United Kingdom

Location

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Iain Moppett, FRCA, MD

  University of Nottingham

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 5, 2022
• First Posted: May 10, 2022
• Study Start: January 27, 2023
• Primary Completion: December 6, 2023
• Study Completion: December 6, 2023
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)