Postoperative Delirium: EEG Markers of Sleep and Wakefulness

ID: NCT03291626
Status: Not yet recruiting
Phase: N/A
Start Date: July 01, 2018
First Submitted: September 14, 2017
Last Updated: February 15, 2018
Results: N/A
Sponsors & Collaborators: Washington University School of Medicine
Location: United States
Conditions: Postoperative Delirium
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Study Description

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.

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.
Condition or disease Intervention/treatment Phase

Postoperative Delirium

N/A

Tracking Information

First Submitted DateSeptember 14, 2017
Last Update Posted DateFebruary 15, 2018
Anticipated Start DateJuly 01, 2018
Anticipated Completion DateFebruary 01, 2022
Anticipated Primary Completion DateSeptember 01, 2021
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • 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

  • 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

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

Not Available

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitlePostoperative Delirium: EEG Markers of Sleep and Wakefulness
Official TitlePostoperative Delirium: EEG Markers of Sleep and Wakefulness
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.

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 TypeObservational
Study PhaseN/A
Estimated Enrollment
220
Allocation
Not Available
Interventional Model
Not Available
Masking
Not Available
Primary Purpose
Not Available
Conditions
Postoperative Delirium
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodNon-Probability Sample
Study PopulationPotential participants recruited from the Barnes Jewish Hospital in St. Louis receiving elective cardiac or major thoracic surgery
Intervention
Not Available
Study Groups/Cohorts
Not Available
Study Arms
Not Available
Arm Intervention/Treatment

Recruitment Information

Recruitment Status:Not yet recruiting
Enrollment220
Completion DateFebruary 01, 2022
Eligibility Criteria: 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
GenderAll
Age60 Years to N/A
Accepts Healthy VolunteersNo
Contacts
Listed Location Countries
United States

Administrative Information

NCT Number:NCT03291626
Other Study ID Numbers
201705018
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible Party,
Study Sponsor
Washington University School of Medicine
Collaborators
Not Available
Investigators
Principal Investigator
Ben Palanca, MD, PhD
Washington University in St Louis SOM