Postoperative Delirium: EEG Markers of Sleep and Wakefulness

January 9, 2025 updated by: Ben J.A. Palanca, Washington University School of Medicine

Postoperative delirium is a condition in which patients develop temporary difficulties in maintaining attention and thinking clearly. These new problems can appear after surgery and change throughout the day. This confusion can last several days.

The overall purpose of this study is to measure brain activity during sleep and wakefulness to learn about their relationships to delirium after surgery. While participants may not feel like their normal self during the study, they are in the best position to help us learn how to improve the recovery of brain function and sleep in others having surgery. The investigators need to learn from those who have and have not become confused after their surgical procedure.

Study Overview

Status

Completed

Conditions

Detailed Description

Postoperative delirium is a condition that can develop in some older patients after they have surgery and receive general anesthesia. Patients that develop delirium have difficulty maintaining attention and thinking clearly. Both of these issues can come and go throughout the day. The incidence of postoperative delirium is greater than 25% and is associated with longer hospitalization and increased risk of persistent mental and physical decline. It is thought that this disorder may be preventable, but there is no agreed upon way of identifying which patients are at risk for delirium prior to their surgery. Additionally, patients with atypical delirium are often misdiagnosed or undiagnosed postoperatively.

Based on previous research, the researchers have hypothesized that delirium may be directly related to wakefulness and sleep problems, as shown on electroencephalography [EEG]. EEG is a test that records the electrical activity of brain through placement of small wires on a person's scalp. In light of this, the purpose of this study is to evaluate sleep and wakefulness using EEG before, during and after surgery in order to discover any abnormalities of sleep or wakefulness that associate with postoperative delirium onset, severity, and length of recovery. Subjects in this study will have preoperative at home sleep testing performed, using a device called the Sleep Profiler, and questionnaires administered to characterize their mental function and brain function prior to surgery. When they arrive for their scheduled surgery, the subjects will be fitted with the Sleep Profiler to record brain activity during surgery and after surgery for 5 days. Postoperatively, the subjects will be asked to do simple tasks like move toes and fingers and to answer questions that assess their mental state.

Study Type

Observational

Enrollment (Actual)

234

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Barnes-Jewish Hospital/Washington University in St. Louis School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Potential participants recruited from the Barnes Jewish Hospital in St. Louis receiving elective cardiac or major thoracic surgery

Description

Inclusion Criteria:

  1. English speaking
  2. Age 60 or older
  3. Scheduled for cardiac surgery requiring cardiopulmonary bypass for coronary artery bypass grafting and/or heart valve repair/replacement

Exclusion Criteria:

  1. Pre-existing delirium or dementia
  2. Legal blindness or severe deafness
  3. Surgery requiring deep hypothermic circulatory rest

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from pre-operative awake EEG measurement to sleep EEG measurement
Time Frame: Record at baseline visit or, if the subject is an inpatient, once during the day compared to record obtained overnight either at home or in the hospital
Awake EEG recorded at baseline, sleep EEG using Sleep Profiler
Record at baseline visit or, if the subject is an inpatient, once during the day compared to record obtained overnight either at home or in the hospital
Change in baseline diagnosis of delirium to hospital discharge
Time Frame: Diagnosis at baseline, then diagnosis change evaluated 2 times daily post-operatively until hospital discharge or post-operative day 5, whichever occurs first.
Delirium diagnosed using the validated instrument Confusion Assessment Method, Long Form
Diagnosis at baseline, then diagnosis change evaluated 2 times daily post-operatively until hospital discharge or post-operative day 5, whichever occurs first.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Investigators

  • Principal Investigator: Ben Palanca, MD, PhD, Washington University in St Louis SOM

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 16, 2018

Primary Completion (Actual)

November 27, 2023

Study Completion (Actual)

November 28, 2024

Study Registration Dates

First Submitted

September 14, 2017

First Submitted That Met QC Criteria

September 21, 2017

First Posted (Actual)

September 25, 2017

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 9, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201705018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data will be shared with the National Sleep Research Resource within three years after completion of the study. We will register our observational study on clinicaltrials.gov and publish a protocol of our approach and pre-specified analyses by the end of Year 2 of funding.

IPD Sharing Time Frame

Data will be made available within 3 years of study completion and publication and will be available indefinitely.

IPD Sharing Access Criteria

Permission from the principal investigator is required for access.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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