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

Abstract

IntroductionDelirium 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 analysisP-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 disseminationP-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 numberNCT03291626.

Perioperative sleep in geriatric cardiac surgical patients: a feasibility study using a wireless wearable device

“…We recruited 100 geriatric cardiac surgical patients at Barnes-Jewish Hospital for this pilot study as part of the prospective observational investigation, Prognosticating Delirium Recovery Outcomes Using Wakefulness and Sleep Electroencephalography (ClinicalTrials.gov NCT03291626). 6 These cardiac surgical patients are at risk for poor clinical outcomes related to disruption of perioperative sleep. 7 Human studies approval was obtained from the institutional review board.…”

“…The modified American Academy of Sleep Medicine criteria for scoring single-channel frontal EEG 4 were further amended to include occipital EEG, closely spaced frontal EEG electrodes, and respiratory effort. 6 Epochs were non-scorable if they did not fulfil staging criteria for wakefulness (W), non-rapid eye movement (N1eN3), and rapid eye movement (REM) sleep. Records were excluded as nonscorable if <60 min of sleep was present.…”

Postoperative Delirium Severity and Recovery Correlate With Electroencephalogram Spectral Features

“…Future large prospective investigations are underway to address the generalizability of our findings. 39…”

Correlating electroconvulsive therapy response to electroencephalographic markers: Study protocol

“…EEG signals and Dreem accelerometry respiratory effort waveforms will be exported in European Data Format (EDF). American Academy of Sleep Medicine (AASM) certified sleep technologists will then stage recordings using Philips Respironics Sleepware G3 Software and modified AASM scoring rules developed for use on single frontal EEG channel recordings ( 96 , 97 ).…”