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

S Kendall Smith, Thomas Nguyen, Alyssa K Labonte, MohammadMehdi Kafashan, Orlandrea Hyche, Christian S Guay, Elizabeth Wilson, Courtney W Chan, Anhthi Luong, L Brian Hickman, Bradley A Fritz, Daniel Emmert, Thomas J Graetz, Spencer J Melby, Brendan P Lucey, Yo-El S Ju, Troy S Wildes, Michael S Avidan, Ben J A Palanca, S Kendall Smith, Thomas Nguyen, Alyssa K Labonte, MohammadMehdi Kafashan, Orlandrea Hyche, Christian S Guay, Elizabeth Wilson, Courtney W Chan, Anhthi Luong, L Brian Hickman, Bradley A Fritz, Daniel Emmert, Thomas J Graetz, Spencer J Melby, Brendan P Lucey, Yo-El S Ju, Troy S Wildes, Michael S Avidan, Ben J A Palanca

Abstract

Introduction: Delirium is a potentially preventable disorder characterised by acute disturbances in attention and cognition with fluctuating severity. Postoperative delirium is associated with prolonged intensive care unit and hospital stay, cognitive decline and mortality. The development of biomarkers for tracking delirium could potentially aid in the early detection, mitigation and assessment of response to interventions. Because sleep disruption has been posited as a contributor to the development of this syndrome, expression of abnormal electroencephalography (EEG) patterns during sleep and wakefulness may be informative. Here we hypothesise that abnormal EEG patterns of sleep and wakefulness may serve as predictive and diagnostic markers for postoperative delirium. Such abnormal EEG patterns would mechanistically link disrupted thalamocortical connectivity to this important clinical syndrome.

Methods and analysis: P-DROWS-E (Prognosticating Delirium Recovery Outcomes Using Wakefulness and Sleep Electroencephalography) is a 220-patient prospective observational study. Patient eligibility criteria include those who are English-speaking, age 60 years or older and undergoing elective cardiac surgery requiring cardiopulmonary bypass. EEG acquisition will occur 1-2 nights preoperatively, intraoperatively, and up to 7 days postoperatively. Concurrent with EEG recordings, two times per day postoperative Confusion Assessment Method (CAM) evaluations will quantify the presence and severity of delirium. EEG slow wave activity, sleep spindle density and peak frequency of the posterior dominant rhythm will be quantified. Linear mixed-effects models will be used to evaluate the relationships between delirium severity/duration and EEG measures as a function of time.

Ethics and dissemination: P-DROWS-E is approved by the ethics board at Washington University in St. Louis. Recruitment began in October 2018. Dissemination plans include presentations at scientific conferences, scientific publications and mass media.

Trial registration number: NCT03291626.

Keywords: adult intensive & critical care; cardiothoracic surgery; delirium & cognitive disorders; neurophysiology; old age psychiatry; sleep medicine.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Overnight electroencephalography (EEG). A hypnogram acquired with the EEG device reveals cycling of sleep stages over an evening with wakefulness (W), rapid eye movement sleep (R) and non-rapid eye movement sleep stages (N1, N2 and N3) (A). The corresponding spectrogram shows signal power in the frontal EEG decomposed by frequency as a function of time. Slow waves (blue arrow) carry low frequency power during N3 sleep, while sleep spindles (red arrow) have power in higher frequencies and occur primarily during N2 sleep (B). Sleep spindles (underlined) occurring at the point designated by the red arrow in panel B are reflected by ~13 Hz power (C). Slow waves occurring at the point designated by the blue arrow in (B) are reflected by 0.5–4 Hz power (D).
Figure 2
Figure 2
The posterior dominant rhythm (PDR) during eyes closed wakefulness using the electroencephalography (EEG) recording device. Alpha oscillations are not easily discernable during eyes open wakefulness (A). During eyes closed wakefulness, the PDR in cognitively intact adults is comprised oscillations in the alpha (8–13 Hz) frequency band (B). This activity is apparent in the decomposition of these two signals into power at corresponding frequencies by spectral analysis. The PDR emerges during eyes closed wakefulness with signal power at ~10 Hz (blue) compared with signal power during eyes open (red) (C). A power spectrogram demonstrates quantifiable fluctuations in the ~10 Hz power during epochs of eyes open vs eyes closed wakefulness (red vs blue arrow) (D).
Figure 3
Figure 3
Overview of electroencephalography (EEG) device and patient participation workflow. Perioperative EEG will be obtained via the Dreem device, a consumer-grade wireless wearable EEG device that records from five sensors, pulse oximetry and accelerometry (A). Longitudinal assessments of EEG and delirium symptomatology will occur preoperatively, intraoperatively and postoperatively. Following consent in the Center for Preoperative Assessment and Planning/inpatient unit, a baseline confusion assessment method (CAM) and EEG are acquired. Postoperative daytime assessments occur within a 2-hour window surrounding 07:00, 13:00 and 19:00 until postoperative day 7, patient withdrawal or hospital discharge (B). The human in this figure is a model and not a patient. Permission was granted for non-commercial use of this image by Dreem.
Figure 4
Figure 4
Prognosticating Delirium Recovery Outcomes Using Wakefulness and Sleep Electroencephalography study overview. CAM, confusion assessment method; EEG, electroencephalography; PDR, posterior dominant rhythm; SWA, slow wave activity.

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