Postoperative Delirium: EEG Markers of Sleep and Wakefulness

NCT03291626 | Completed

• 1 other identifier: 201705018
• Study Type: observational
• Target: 234
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Delirium

Outcome Measures

Primary Outcomes (2)

• Change from pre-operative awake EEG measurement to sleep EEG measurement

  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

  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.

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• Pre-existing delirium or dementia
• Legal blindness or severe deafness
• Surgery requiring deep hypothermic circulatory rest

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Barnes-Jewish Hospital/Washington University in St. Louis School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (2)

• Luong AH, Smith SK, Bhatia K, Kafashan M, Nguyen T, Hyche O, Schill M, Damiano RJ Jr, Palanca BJA. New-Onset Postoperative Atrial Fibrillation and Preoperative Sleep in Cardiac Surgical Patients. Ann Thorac Surg Short Rep. 2024 Jul 26;3(1):258-263. doi: 10.1016/j.atssr.2024.07.010. eCollection 2025 Mar.

  PMID: 40098862 DERIVED

• Smith SK, Nguyen T, Labonte AK, Kafashan M, Hyche O, Guay CS, Wilson E, Chan CW, Luong A, Hickman LB, Fritz BA, Emmert D, Graetz TJ, Melby SJ, Lucey BP, Ju YS, Wildes TS, Avidan MS, Palanca BJA. Protocol for the Prognosticating Delirium Recovery Outcomes Using Wakefulness and Sleep Electroencephalography (P-DROWS-E) study: a prospective observational study of delirium in elderly cardiac surgical patients. BMJ Open. 2020 Dec 13;10(12):e044295. doi: 10.1136/bmjopen-2020-044295.

  PMID: 33318123 DERIVED

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

• Ben Palanca, MD, PhD

  Washington University in St Louis SOM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc Prof of Anesthesiology

Study Record Dates

• First Submitted: September 14, 2017
• First Posted: September 25, 2017
• Study Start: October 16, 2018
• Primary Completion: November 27, 2023
• Study Completion: November 28, 2024
• Last Updated: January 13, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be made available within 3 years of study completion and publication and will be available indefinitely.
• Access Criteria: Permission from the principal investigator is required for access.

Locations

US (1)