Publications by authors named "Michael S Avidan"

163 Publications

Factors Contributing to Lingering Pain after Surgery: The Role of Patient Expectations.

Anesthesiology 2021 Apr 8. Epub 2021 Apr 8.

Background: Pain that lingers beyond the early weeks after the acute postoperative period is an important risk factor for chronic postsurgical pain. This study examined the hypothesis that patients' expectations about their postsurgical pain would be independently associated with lingering postsurgical pain.

Methods: The study included 3,628 patients who underwent diverse surgeries between February 2015 and October 2016 in a single U.S. tertiary hospital and participated in the Systematic Assessment and Targeted Improvement of Services Following Yearlong Surgical Outcomes Surveys (SATISFY-SOS) observational study. Preoperatively, patients were asked about their expectations about pain 1 month after surgery. Patients were considered to have lingering postsurgical pain if they endorsed having pain in the area related to their surgeries during a follow-up survey obtained 1 to 3 months postoperatively. The independent associations between preselected perioperative variables and lingering postsurgical pain were evaluated.

Results: Of the cohort, 36% (1,308 of 3,628) experienced lingering postsurgical pain. Overall, two thirds (2,414 of 3,628) expected their postsurgical pain to be absent or improved from baseline, and 73% of these had their positive expectations fulfilled. A total of 19% (686 of 3,628) expected new, unabated, or worsened pain, and only 39% (257 of 661) of these had their negative expectations fulfilled. Negative expectations were most common in patients with presurgical pain unrelated to the reason for surgery, undergoing surgeries not typically performed to help alleviate pain. Endorsing negative expectations was independently associated with lingering postsurgical pain (odds ratio, 1.56; 95% CI, 1.23 to 1.98; P < 0.001). Additional major factors associated with lingering postsurgical pain included recollection of severe acute postoperative pain (odds ratio, 3.13; 95% CI, 2.58 to 3.78; P < 0.001), undergoing a procedure typically performed to help alleviate pain (odds ratio, 2.18; 95% CI, 1.73 to 2.75; P < 0.001), and preoperative pain related to surgery (odds ratio, 1.91; 95% CI, 1.52 to 2.40; P < 0.001).

Conclusions: Lingering postsurgical pain is relatively common after diverse surgeries and is associated with both fixed surgical characteristics and potentially modifiable factors like pain expectations and severe acute postoperative pain.

Editor’s Perspective:
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http://dx.doi.org/10.1097/ALN.0000000000003754DOI Listing
April 2021

Acute Symptoms of Mild to Moderate COVID-19 Are Highly Heterogeneous Across Individuals and Over Time.

Open Forum Infect Dis 2021 Mar 1;8(3):ofab090. Epub 2021 Mar 1.

Department of Internal Medicine, Division of Infectious Diseases, WUSM, St Louis, Missouri, USA.

Background: The symptoms of coronavirus disease 2019 (COVID-19) appear to be heterogenous, and the typical course of these symptoms is unknown. Our objectives were to characterize the common trajectories of COVID-19 symptoms and to assess how symptom course predicts other symptom changes as well as clinical deterioration.

Methods: One hundred sixty-two participants with acute COVID-19 responded to surveys up to 31 times for up to 17 days. Several statistical methods were used to characterize the temporal dynamics of these symptoms. Because 9 participants showed clinical deterioration, we explored whether these participants showed any differences in symptom profiles.

Results: Trajectories varied greatly between individuals, with many having persistently severe symptoms or developing new symptoms several days after being diagnosed. A typical trajectory was for a symptom to improve at a decremental rate, with most symptoms still persisting to some degree at the end of the reporting period. The pattern of symptoms over time suggested a fluctuating course for many patients. Participants who showed clinical deterioration were more likely to present with higher reports of severity of cough and diarrhea.

Conclusions: The course of symptoms during the initial weeks of COVID-19 is highly heterogeneous and is neither predictable nor easily characterized using typical survey methods. This has implications for clinical care and early-treatment clinical trials. Additional research is needed to determine whether the decelerating improvement pattern seen in our data is related to the phenomenon of patients reporting long-term symptoms and whether higher symptoms of diarrhea in early illness presages deterioration.
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http://dx.doi.org/10.1093/ofid/ofab090DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7989225PMC
March 2021

Use of Machine Learning to Develop and Evaluate Models Using Preoperative and Intraoperative Data to Identify Risks of Postoperative Complications.

JAMA Netw Open 2021 Mar 1;4(3):e212240. Epub 2021 Mar 1.

Institute for Informatics, Washington University in St Louis School of Medicine, St Louis, Missouri.

Importance: Postoperative complications can significantly impact perioperative care management and planning.

Objectives: To assess machine learning (ML) models for predicting postoperative complications using independent and combined preoperative and intraoperative data and their clinically meaningful model-agnostic interpretations.

Design, Setting, And Participants: This retrospective cohort study assessed 111 888 operations performed on adults at a single academic medical center from June 1, 2012, to August 31, 2016, with a mean duration of follow-up based on the length of postoperative hospital stay less than 7 days. Data analysis was performed from February 1 to September 31, 2020.

Main Outcomes And Measures: Outcomes included 5 postoperative complications: acute kidney injury (AKI), delirium, deep vein thrombosis (DVT), pulmonary embolism (PE), and pneumonia. Patient and clinical characteristics available preoperatively, intraoperatively, and a combination of both were used as inputs for 5 candidate ML models: logistic regression, support vector machine, random forest, gradient boosting tree (GBT), and deep neural network (DNN). Model performance was compared using the area under the receiver operating characteristic curve (AUROC). Model interpretations were generated using Shapley Additive Explanations by transforming model features into clinical variables and representing them as patient-specific visualizations.

Results: A total of 111 888 patients (mean [SD] age, 54.4 [16.8] years; 56 915 [50.9%] female; 82 533 [73.8%] White) were included in this study. The best-performing model for each complication combined the preoperative and intraoperative data with the following AUROCs: pneumonia (GBT), 0.905 (95% CI, 0.903-0.907); AKI (GBT), 0.848 (95% CI, 0.846-0.851); DVT (GBT), 0.881 (95% CI, 0.878-0.884); PE (DNN), 0.831 (95% CI, 0.824-0.839); and delirium (GBT), 0.762 (95% CI, 0.759-0.765). Performance of models that used only preoperative data or only intraoperative data was marginally lower than that of models that used combined data. When adding variables with missing data as input, AUROCs increased from 0.588 to 0.905 for pneumonia, 0.579 to 0.848 for AKI, 0.574 to 0.881 for DVT, 0.5 to 0.831 for PE, and 0.6 to 0.762 for delirium. The Shapley Additive Explanations analysis generated model-agnostic interpretation that illustrated significant clinical contributors associated with risks of postoperative complications.

Conclusions And Relevance: The ML models for predicting postoperative complications with model-agnostic interpretation offer opportunities for integrating risk predictions for clinical decision support. Such real-time clinical decision support can mitigate patient risks and help in anticipatory management for perioperative contingency planning.
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http://dx.doi.org/10.1001/jamanetworkopen.2021.2240DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8010590PMC
March 2021

Closed-Loop Acoustic Stimulation During Sedation with Dexmedetomidine (CLASS-D): Protocol for a Within-Subject, Crossover, Controlled, Interventional Trial with Healthy Volunteers.

Nat Sci Sleep 2021 4;13:303-313. Epub 2021 Mar 4.

Department of Anesthesiology, Washington University School of Medicine in St. Louis, St. Louis, MO, USA.

Introduction: The relative power of slow-delta oscillations in the electroencephalogram (EEG), termed slow-wave activity (SWA), correlates with level of unconsciousness. Acoustic enhancement of SWA has been reported for sleep states, but it remains unknown if pharmacologically induced SWA can be enhanced using sound. Dexmedetomidine is a sedative whose EEG oscillations resemble those of natural sleep. This pilot study was designed to investigate whether SWA can be enhanced using closed-loop acoustic stimulation during sedation (CLASS) with dexmedetomidine.

Methods: Closed-Loop Acoustic Stimulation during Sedation with Dexmedetomidine (CLASS-D) is a within-subject, crossover, controlled, interventional trial with healthy volunteers. Each participant will be sedated with a dexmedetomidine target-controlled infusion (TCI). Participants will undergo three CLASS conditions in a multiple crossover design: in-phase (phase-locked to slow-wave upslopes), anti-phase (phase-locked to slow-wave downslopes) and sham (silence). High-density EEG recordings will assess the effects of CLASS across the scalp. A volitional behavioral task and sequential thermal arousals will assess the anesthetic effects of CLASS. Ambulatory sleep studies will be performed on nights immediately preceding and following the sedation session. EEG effects of CLASS will be assessed using linear mixed-effects models. The impacts of CLASS on behavior and arousal thresholds will be assessed using logistic regression modeling. Parametric modeling will determine differences in sleepiness and measures of sleep homeostasis before and after sedation.

Results: The primary outcome of this pilot study is the effect of CLASS on EEG slow waves. Secondary outcomes include the effects of CLASS on the following: performance of a volitional task, arousal thresholds, and subsequent sleep.

Discussion: This investigation will elucidate 1) the potential of exogenous sensory stimulation to potentiate SWA during sedation; 2) the physiologic significance of this intervention; and 3) the connection between EEG slow-waves observed during sleep and sedation.
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http://dx.doi.org/10.2147/NSS.S293160DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7939493PMC
March 2021

Perioperative Mental Health in Older Adults: New Research on Epidemiology and Outcomes.

Am J Geriatr Psychiatry 2021 Feb 6. Epub 2021 Feb 6.

Department of Psychiatry, Washington University School of Medicine (EJL), St Louis, MS. Electronic address:

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http://dx.doi.org/10.1016/j.jagp.2021.02.036DOI Listing
February 2021

Postictal generalized electroencephalographic suppression following electroconvulsive therapy: Temporal characteristics and impact of anesthetic regimen.

Clin Neurophysiol 2021 Apr 28;132(4):977-983. Epub 2021 Jan 28.

Department of Anesthesiology, Washington University School of Medicine in St. Louis, St. Louis, MO, USA; Division of Biology and Biomedical Sciences, Washington University School of Medicine in St. Louis, St. Louis, MO, USA; Department of Psychiatry, Washington University School of Medicine in St. Louis, St. Louis, MO, USA; Department of Biomedical Engineering, Washington University in St. Louis, St. Louis, MO, USA. Electronic address:

Objective: Postictal generalized electroencephalographic suppression (PGES) has been defined as electroencephalographic (EEG) activity of less than 10 microvolts following a generalized seizure. PGES is associated with an increased risk of sudden unexplained death in epilepsy, as well as treatment efficacy of electroconvulsive therapy (ECT). We investigated the impact of anesthetic on PGES expression and temporal characteristics.

Methods: We recorded postictal EEG in 50 ECT sessions in 11 patients with treatment resistant depression (ClinicalTrials.gov NCT02761330). For each participant, repeated sessions included either ketamine or etomidate general anesthesia during ECT. An automated algorithm was employed to detect PGES within 5 minutes after seizure termination.

Results: PGES was detected in 31/50 recordings, with intermittent epochs recurring up to five minutes after seizure termination. PGES total duration was greater following ketamine than etomidate anesthesia (p = 0.04). PGES expression declined loglinearly as a function of time (r = -0.89, p < 10). EEG amplitude during PGES did not vary linearly with time.

Conclusions: PGES can occur intermittently for several minutes following seizure termination. Anesthetic effects should be considered when correlating PGES duration to clinical outcomes.

Significance: Prolonged EEG monitoring several minutes following seizure termination may be necessary to fully evaluate the presence and total duration of PGES.
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http://dx.doi.org/10.1016/j.clinph.2020.12.018DOI Listing
April 2021

Brain network motifs are markers of loss and recovery of consciousness.

Sci Rep 2021 Feb 16;11(1):3892. Epub 2021 Feb 16.

School of Physical and Occupational Therapy, McGill University, Montreal, Canada.

Motifs are patterns of inter-connections between nodes of a network, and have been investigated as building blocks of directed networks. This study explored the re-organization of 3-node motifs during loss and recovery of consciousness. Nine healthy subjects underwent a 3-h anesthetic protocol while 128-channel electroencephalography (EEG) was recorded. In the alpha (8-13 Hz) band, 5-min epochs of EEG were extracted for: Baseline; Induction; Unconscious; 30-, 10- and 5-min pre-recovery of responsiveness; 30- and 180-min post-recovery of responsiveness. We constructed a functional brain network using the weighted and directed phase lag index, on which we calculated the frequency and topology of 3-node motifs. Three motifs (motifs 1, 2 and 5) were significantly present across participants and epochs, when compared to random networks (p < 0.05). The topology of motifs 1 and 5 changed significantly between responsive and unresponsive epochs (p-values < 0.01; Kendall's W = 0.664 (motif 1) and 0.529 (motif 5)). Motif 1 was constituted of long-range chain-like connections, while motif 5 was constituted of short-range, loop-like connections. Our results suggest that anesthetic-induced unconsciousness is associated with a topological re-organization of network motifs. As motif topological re-organization may precede (motif 5) or accompany (motif 1) the return of responsiveness, motifs could contribute to the understanding of the neural correlates of consciousness.
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http://dx.doi.org/10.1038/s41598-021-83482-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7887248PMC
February 2021

Systematic review and meta-analysis of interventions for operating room to intensive care unit handoffs.

BMJ Qual Saf 2021 Feb 9. Epub 2021 Feb 9.

Department of Anesthesiology, Washington University School of Medicine in St Louis, St Louis, Missouri, USA.

Objective: To conduct a systematic review and meta-analysis to ascertain the impact of operating room (OR) to intensive care unit (ICU) handoff interventions on process-based and clinical outcomes.

Method: We included all English language, prospective evaluation studies of OR to ICU handoff interventions published as original research articles in peer-reviewed journals. The search was conducted on 11 November 2019 on MEDLINE, CINAHL, EMBASE, Scopus and the Cochrane Central Register of Controlled Trials databases, with no prespecified criteria for the type of comparison or outcome. A meta-analysis of similar outcomes was conducted using a random effects model. Quality was assessed using a modified Downs and Black (D&B) checklist.

Results: 32 studies were included for review. 31 studies were conducted at a single site and 28 studies used an observational study design with a control. Most studies (n=28) evaluated bundled interventions which comprised information transfer/communication checklists and protocols. Meta-analysis showed that the handoff intervention group had statistically significant improvements in time to analgesia dosing (mean difference (MD)=-42.51 min, 95% CI -60.39 to -24.64), fewer information omissions (MD=-2.22, 95% CI -3.68 to -0.77), fewer technical errors (MD=-2.38, 95% CI -4.10 to -0.66) and greater information sharing scores (MD=30.03%, 95% CI 19.67% to 40.40%). Only 15 of the 32 studies scored above 9 points on the modified D&B checklist, indicating a lack of high-quality studies.

Discussion: Bundled interventions were commonly used to support OR to ICU handoff standardisation. Although the meta-analysis showed significant improvements for a number of clinical and process outcomes, the statistical and clinical heterogeneity must be accounted for when interpreting these findings. Implications for OR to ICU handoff practice and future research are discussed.
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http://dx.doi.org/10.1136/bmjqs-2020-012474DOI Listing
February 2021

The ED-AWARENESS Study: A Prospective, Observational Cohort Study of Awareness With Paralysis in Mechanically Ventilated Patients Admitted From the Emergency Department.

Ann Emerg Med 2021 Jan 20. Epub 2021 Jan 20.

Department of Emergency Medicine, St. Louis, MO; Department of Anesthesiology, St. Louis, MO. Electronic address:

Study Objective: Awareness with paralysis is a devastating complication for patients receiving mechanical ventilation and risks long-term psychological morbidity. Data from the emergency department (ED) demonstrate a high rate of longer-acting neuromuscular blocking agent use, delayed analgosedation, and a lack of sedation depth monitoring. These practices are discordant with recommendations for preventing awareness with paralysis. Despite this, awareness with paralysis has not been rigorously studied in the ED population. Our objective is to assess the prevalence of awareness with paralysis in ED patients receiving mechanical ventilation.

Methods: This was a single-center, prospective, observational cohort study on 383 mechanically ventilated ED patients. After extubation, we assessed patients for awareness with paralysis by using the modified Brice questionnaire. Three expert reviewers independently adjudicated awareness with paralysis. We report the prevalence of awareness with paralysis (primary outcome); the secondary outcome was perceived threat, a mediator for development of posttraumatic stress disorder.

Results: The prevalence of awareness with paralysis was 2.6% (10/383). Exposure to rocuronium at any point in the ED was significantly different between patients who experienced awareness with paralysis (70%) versus the rest of the cohort (31.4%) (unadjusted odds ratio 5.1; 95% confidence interval 1.30 to 20.1). Patients experiencing awareness with paralysis had higher mean values on the threat perception scale, denoting a higher degree of perceived threat, compared with patients who did not experience awareness with paralysis (13.4 [SD 7.7] versus 8.5 [SD 6.2]; mean difference 4.9; 95% confidence interval 0.94 to 8.8).

Conclusion: Awareness with paralysis occurs in a significant minority of ED patients who receive mechanical ventilation. Potential associations of awareness with paralysis with ED care and increased perceived threat warrant further evaluation.
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http://dx.doi.org/10.1016/j.annemergmed.2020.10.012DOI Listing
January 2021

Correction to: An updated introduction to electroencephalogram-based brain monitoring duringintended general anesthesia.

Can J Anaesth 2021 Jan 11. Epub 2021 Jan 11.

Department of Anesthesiology, Washington University School of Medicine, 660 South Euclid Avenue, Campus Box 8054, St. Louis, MO, USA.

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http://dx.doi.org/10.1007/s12630-020-01877-0DOI Listing
January 2021

Correction to: An updated introduction to electroencephalogram-based brain monitoring during intended general anesthesia.

Can J Anaesth 2021 Jan 7. Epub 2021 Jan 7.

Department of Anesthesiology, Washington University School of Medicine, 660 South Euclid Avenue, Campus, Box 8054, St. Louis, MO, USA.

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http://dx.doi.org/10.1007/s12630-020-01891-2DOI Listing
January 2021

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 12 13;10(12):e044295. Epub 2020 Dec 13.

Department of Anesthesiology, Washington University in Saint Louis School of Medicine, Saint Louis, Missouri, USA

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.
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http://dx.doi.org/10.1136/bmjopen-2020-044295DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7737109PMC
December 2020

Protocol for a proof-of-concept observational study evaluating the potential utility and acceptability of a telemedicine solution for the post-anesthesia care unit.

F1000Res 2020 20;9:1261. Epub 2020 Oct 20.

Department of Anesthesiology, Washington University School of Medicine, St. Louis, MO, 63110, USA.

The post-anesthesia care unit (PACU) is a clinical area designated for patients recovering from invasive procedures. There are typically several geographically dispersed PACUs within hospitals. Patients in the PACU can be unstable and at risk for complications. However, clinician coverage and patient monitoring in PACUs is not well regulated and might be sub-optimal. We hypothesize that a telemedicine center for the PACU can improve key PACU functions. The objective of this study is to demonstrate the potential utility and acceptability of a telemedicine center to complement the key functions of the PACU. These include participation in hand-off activities to and from the PACU, detection of physiological derangements, identification of symptoms requiring treatment, recognition of situations requiring emergency medical intervention, and determination of patient readiness for PACU discharge. This will be a single center prospective before-and-after proof-of-concept study. Adults (18 years and older) undergoing elective surgery and recovering in two selected PACU bays will be enrolled. During the initial three-month observation phase, clinicians in the telemedicine center will not communicate with clinicians in the PACU, unless there is a specific patient safety concern. During the subsequent three-month interaction phase, clinicians in the telemedicine center will provide structured decision support to PACU clinicians. The primary outcome will be time to PACU discharge readiness determination in the two study phases. The attitudes of key stakeholders towards the telemedicine center will be assessed. Other outcomes will include detection of physiological derangements, complications, adverse symptoms requiring treatments, and emergencies requiring medical intervention. This trial is registered on clinicaltrials.gov, NCT04020887 (16 July 2019).
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http://dx.doi.org/10.12688/f1000research.26794.1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7656276PMC
October 2020

Continuing professional development module : An updated introduction to electroencephalogram-based brain monitoring during intended general anesthesia.

Can J Anaesth 2020 Dec 15;67(12):1858-1878. Epub 2020 Nov 15.

Department of Anesthesiology, Washington University School of Medicine, 660 South Euclid Avenue, Campus Box 8054, St. Louis, MO, USA.

The electroencephalogram (EEG) provides a reliable reflection of the brain's electrical state, so it can reassure us that the anesthetic agents are actually reaching the patient's brain, and are having the desired effect. In most patients, the EEG changes somewhat predictably in response to propofol and volatile agents, so a frontal EEG channel can guide avoidance of insufficient and excessive administration of general anesthesia. Persistent alpha-spindles (around 10 Hz) phase-amplitude coupled with slow delta waves (around 1 Hz) are commonly seen during an "appropriate hypnotic state of general anesthesia". Such patterns can be appreciated from the EEG waveform or from the spectrogram (a colour-coded display of how the power in the various EEG frequencies changes with time). Nevertheless, there are exceptions to this. For example, administration of ketamine and nitrous oxide is generally not associated with the aforementioned alpha-spindle coupled with delta wave pattern. Also, some patients, including older adults and those with neurodegenerative disorders, are less predisposed to generate a strong electroencephalographic "alpha-spindle" pattern during general anesthesia. There might also be some rare instances when the frontal EEG shows a pattern suggestive of general anesthesia, while the patient has some awareness and is able to follow simple commands, albeit this is typically without obvious distress or memory formation. Thus, the frontal EEG alone, as currently analyzed, is an imperfect but clinically useful mirror, and more scientific insights will be needed before we can claim to have a reliable readout of brain "function" during general anesthesia.
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http://dx.doi.org/10.1007/s12630-020-01820-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7666718PMC
December 2020

Fluvoxamine vs Placebo and Clinical Deterioration in Outpatients With Symptomatic COVID-19: A Randomized Clinical Trial.

JAMA 2020 12;324(22):2292-2300

Department of Psychiatry, School of Medicine, Washington University in St Louis, St Louis, Missouri.

Importance: Coronavirus disease 2019 (COVID-19) may lead to serious illness as a result of an excessive immune response. Fluvoxamine may prevent clinical deterioration by stimulating the σ-1 receptor, which regulates cytokine production.

Objective: To determine whether fluvoxamine, given during mild COVID-19 illness, prevents clinical deterioration and decreases the severity of disease.

Design, Setting, And Participants: Double-blind, randomized, fully remote (contactless) clinical trial of fluvoxamine vs placebo. Participants were community-living, nonhospitalized adults with confirmed severe acute respiratory syndrome coronavirus 2 infection, with COVID-19 symptom onset within 7 days and oxygen saturation of 92% or greater. One hundred fifty-two participants were enrolled from the St Louis metropolitan area (Missouri and Illinois) from April 10, 2020, to August 5, 2020. The final date of follow-up was September 19, 2020.

Interventions: Participants were randomly assigned to receive 100 mg of fluvoxamine (n = 80) or placebo (n = 72) 3 times daily for 15 days.

Main Outcomes And Measures: The primary outcome was clinical deterioration within 15 days of randomization defined by meeting both criteria of (1) shortness of breath or hospitalization for shortness of breath or pneumonia and (2) oxygen saturation less than 92% on room air or need for supplemental oxygen to achieve oxygen saturation of 92% or greater.

Results: Of 152 patients who were randomized (mean [SD] age, 46 [13] years; 109 [72%] women), 115 (76%) completed the trial. Clinical deterioration occurred in 0 of 80 patients in the fluvoxamine group and in 6 of 72 patients in the placebo group (absolute difference, 8.7% [95% CI, 1.8%-16.4%] from survival analysis; log-rank P = .009). The fluvoxamine group had 1 serious adverse event and 11 other adverse events, whereas the placebo group had 6 serious adverse events and 12 other adverse events.

Conclusions And Relevance: In this preliminary study of adult outpatients with symptomatic COVID-19, patients treated with fluvoxamine, compared with placebo, had a lower likelihood of clinical deterioration over 15 days. However, the study is limited by a small sample size and short follow-up duration, and determination of clinical efficacy would require larger randomized trials with more definitive outcome measures.

Trial Registration: ClinicalTrials.gov Identifier: NCT04342663.
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http://dx.doi.org/10.1001/jama.2020.22760DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7662481PMC
December 2020

Voltage-based automated detection of postictal generalized electroencephalographic suppression: Algorithm development and validation.

Clin Neurophysiol 2020 Dec 11;131(12):2817-2825. Epub 2020 Sep 11.

Department of Anesthesiology, Washington University School of Medicine in St. Louis, St. Louis, MO, USA; Division of Biology and Biomedical Sciences, Washington University School of Medicine in St. Louis, St. Louis, MO, USA; Department of Biomedical Engineering, Washington University in St. Louis, St. Louis, MO, USA. Electronic address:

Objective: Postictal generalized electroencephalographic suppression (PGES) is a pattern of low-voltage scalp electroencephalographic (EEG) activity following termination of generalized seizures. PGES has been associated with both sudden unexplained death in patients with epilepsy and therapeutic efficacy of electroconvulsive therapy (ECT). Automated detection of PGES epochs may aid in reliable quantification of this phenomenon.

Methods: We developed a voltage-based algorithm for detecting PGES. This algorithm applies existing criteria to simulate expert epileptologist readings. Validation relied on postictal EEG recording from patients undergoing ECT (NCT02761330), assessing concordance among the algorithm and four clinical epileptologists.

Results: We observed low-to-moderate concordance among epileptologist ratings of PGES. Despite this, the algorithm displayed high discriminability in comparison to individual epileptologists (C-statistic range: 0.86-0.92). The algorithm displayed high discrimination (C-statistic: 0.91) and substantial peak agreement (Cohen's Kappa: 0.65) in comparison to a consensus of clinical ratings. Interrater agreement between the algorithm and individual epileptologists was on par with that among expert epileptologists.

Conclusions: An automated voltage-based algorithm can be used to detect PGES following ECT, with discriminability nearing that of experts.

Significance: Algorithmic detection may support clinical readings of PGES and improve precision when correlating this marker with clinical outcomes following generalized seizures.
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http://dx.doi.org/10.1016/j.clinph.2020.08.015DOI Listing
December 2020

In Response.

Anesth Analg 2020 11;131(5):e227

Department of Anesthesiology, Washington University School of Medicine, St Louis, Missouri,

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http://dx.doi.org/10.1213/ANE.0000000000005119DOI Listing
November 2020

Surgical Complications in Older Adults Predict Decline in Self-Perceived Cognitive Function in the Ensuing Year: A Cohort Study.

Am J Geriatr Psychiatry 2021 04 7;29(4):352-361. Epub 2020 Sep 7.

Department of Anesthesiology (TK, KJH, JA, UN, SH, MSA), Washington University School of Medicine, St Louis, MO.

Background: Surgical complications are common among older adults and are potential indicators of poorer long-term outcomes. The authors examined the effects of in-hospital complications on changes in older adults' self-perceived cognitive function in the year after surgery.

Method: The authors conducted a prospective longitudinal study with 2,155 older adults (age ≥ 65) undergoing surgery, investigating the association between self-reported, in-hospital complications after surgery and Patient-Reported Outcomes Measurement Information System Applied Cognition-Abilities survey (4 items, cognitive function) at 30 days and 1 year after surgery. Surveys were scored on a continuous scale of 0-100, with higher scores representing better self-perceived cognitive functioning. Patient characteristics including demographics, type of complications, surgery type, pain, and activities of daily living were also collected.

Results: Having one in-hospital complication was associated with a decrease of 1.79 points (95% confidence interval (CI): -2.78, -0.80), indicating lower self-perceived cognitive functioning at 1 year after surgery; having two or more in-hospital complications was associated with 2.82 point (95% CI: -4.50, -1.15) decrease at 1 year after surgery. Models specific to complication type indicated that respiratory [-3.04, (95% CI: -5.50, -0.57)], neural [-2.11, (95% CI: -3.97, -0.25)], and general complications [-2.39, (95% CI: -3.51, -1.28)] were associated with statistically significant decreases in cognitive function.

Discussion: Older surgical patients who suffer in-hospital complications show greater decline in self-perceived cognitive function during the ensuing year. Geriatric specialists may be able to intervene in the immediate perioperative period to reduce complications and possibly mitigate cognitive decline among older adults.
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http://dx.doi.org/10.1016/j.jagp.2020.09.007DOI Listing
April 2021

Recommendations and Alerting for Delirium Alleviation in Real-Time (RADAR): Protocol for a pilot randomized controlled trial.

F1000Res 2019 24;8:1683. Epub 2019 Sep 24.

Department of Internal Medicine, Division of Geriatric and Palliative Medicine, University of Michigan Medical School, Ann Arbor, MI, 48109, USA.

Delirium is a common and serious complication of major surgery for older adults. Postoperative social and behavioral support (e.g., early mobilization, mealtime assistance) may reduce the incidence and impact of delirium, and these efforts are possible with proactive patient-care programs. This pilot trial tests the hypothesis that a multicomponent decision support system, which sends automated alerts and recommendations to patient-care programs and family members for high-risk patients, will improve the postoperative environment for neurocognitive and clinical recovery. This will be a randomized, controlled, factorial pilot trial at a large academic medical center. High-risk, non-cardiac surgery patients (≥70 years old) will be recruited. Patients will be allocated to a usual care group (n=15), Hospital Elder Life Program (HELP)-based paging system (n=15), family-based paging system (n=15), or combined HELP- and family-based system (n=15). The primary outcome will be the presence of delirium, defined by positive long-form Confusion Assessment Method screening. Secondary outcomes will include additional HELP- and family-based performance metrics along with various neurocognitive and clinical recovery measures. Exploratory outcomes include the incidence of positive family-based delirium assessments post-discharge, 36-item Short Form Survey, PROMIS Cognitive Function Abilities Subset 4a, and 30-day readmission rates. This trial has received approval by the University of Michigan Medical Institutional Review Board (IRBMED). Dissemination plans include presentation at scientific conferences, publication in medical journals, and distribution via educational and news media. ClinicalTrials.gov Identifier NCT04007523, registered on 7/3/2019.
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http://dx.doi.org/10.12688/f1000research.20597.2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7471625PMC
October 2020

Deep anaesthesia.

Lancet 2020 09;396(10252):666

Department of Anesthesiology, Washington University School of Medicine, St Louis, MO, USA.

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http://dx.doi.org/10.1016/S0140-6736(20)30911-9DOI Listing
September 2020

Statistics of heart failure and mechanical circulatory support in 2020.

Ann Transl Med 2020 Jul;8(13):827

Department of Anesthesiology, Washington University, Saint Louis, MO, USA.

Heart failure is increasing in prevalence, with approximately 26 million patients affected worldwide. This represents a significant cause of morbidity and mortality. Statistics regarding heart failure patient age, hospitalization likelihood, and mortality differ significantly by country. Heart failure patients are typically classified by ejection fraction, with distinct phenotypes associated with reduced ejection fraction (rEF) or preserved ejection fraction (pEF). Heart failure has a significant financial impact related to hospitalization, medication, and procedural expenses. The costs of heart failure also extend to the reduced quality of life conferred by heart failure symptoms. Management of heart failure includes a variety of interventions, including mechanical circulatory support (MCS). MCS, including left ventricular assist devices (LVADs), right ventricular assist devices (RVADs) and extracorporeal membrane oxygenation (ECMO), has been a means of managing end stage heart failure. Given the relative scarcity of transplant organs, the utilization of MCS, particularly as a bridge to transplantation (BTT) has grown significantly. In this review, we discuss statistics related to heart failure and MCS. We evaluate how patients are classified and examine global trends and regional differences. We then address MCS therapies, the costs associated with heart failure, the impact of heart failure on patient quality of life, and data regarding morbidity and mortality.
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http://dx.doi.org/10.21037/atm-20-1127DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7396255PMC
July 2020

Building a Collaborative Culture: Focus on Psychological Safety and Error Reporting.

Ann Thorac Surg 2021 02 25;111(2):683-689. Epub 2020 Jul 25.

Department of Anesthesiology, Washington University School of Medicine in St Louis, St Louis, Missouri.

Background: At a Midwestern academic medical center, we introduced a structured teamwork training program to cardiothoracic operating room members with a goal of greater than or equal to 90% reporting positive psychological safety after the program.

Methods: We conducted teamwork training over 3 months. We distributed confidential questionnaires before the training, and then at 6 months and 12 months after the training. The primary outcome was the percentage of respondents reporting good or excellent psychological safety. Surveys were also distributed at the end of each case. Secondary outcomes were medical errors reported. Comparisons between percentages were evaluated with chi-square test. We examined the turnover of nurses and surgical technologists.

Results: Positive psychological safety was reported by 57 of 73 (78.1%) at baseline and by 60 of 68 (88.2%) at 12 months (difference = 10.1%; 95% confidence interval, -2.4% to 23.4%; P = .122). On the daily survey, 93.9% (n = 2786 of 2987) of operating room team members strongly agreed with the statement "I felt comfortable speaking up with questions and concerns" during the last quarter of the study. Reported medical errors decreased from 7.44% (n = 78 of 1048) in the first 6 months of the study to 4.65% (n = 55 of 1184) in the second 6 months (difference = 2.79%; 95% confidence interval, 0.8% to 4.8%; P = .005). In 2015, 19 nurses of a pool of 40 (47.5%) left, followed by 7 (17.5%) in 2016 and 10 (25%) in 2017.

Conclusions: Overall, the results of this study suggest that structured teamwork training in the cardiothoracic operating room environment has the potential to improve teamwork, psychological safety, and communication, and potentially also patient outcomes.
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http://dx.doi.org/10.1016/j.athoracsur.2020.05.152DOI Listing
February 2021

Hydroxychloroquine as Postexposure Prophylaxis for Covid-19.

N Engl J Med 2020 09 15;383(11):1087-1088. Epub 2020 Jul 15.

University of the Witwatersrand, Johannesburg, South Africa.

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http://dx.doi.org/10.1056/NEJMc2023617DOI Listing
September 2020

No Brain Is an Island.

Anesth Analg 2020 06;130(6):1568-1571

From the Department of Anesthesiology, Washington University School of Medicine, St Louis, Missouri.

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http://dx.doi.org/10.1213/ANE.0000000000004704DOI Listing
June 2020

Association Between Preoperative Obstructive Sleep Apnea and Preoperative Positive Airway Pressure With Postoperative Intensive Care Unit Delirium.

JAMA Netw Open 2020 04 1;3(4):e203125. Epub 2020 Apr 1.

Department of Anesthesiology, Washington University in St Louis, St Louis, Missouri.

Importance: Obstructive sleep apnea has been associated with postoperative delirium, which predisposes patients to major adverse outcomes. Positive airway pressure may be an effective intervention to reduce delirium in this population.

Objectives: To determine if preoperative obstructive sleep apnea is associated with postoperative incident delirium in the intensive care unit and if preoperative positive airway pressure adherence modifies the association.

Design, Setting, And Participants: A retrospective single-center cohort study was conducted at a US tertiary hospital from November 1, 2012, to August 31, 2016, among 7792 patients admitted to an intensive care unit who underwent routine Confusion Assessment Method for the intensive care unit after major surgery. Patients were adults who had undergone a complete preoperative anesthesia assessment, received general anesthesia, underwent at least 1 delirium assessment, were not delirious preoperatively, and had a preoperative intensive care unit stay of less than 6 days. Statistical analysis was conducted from August 20, 2019, to January 11, 2020.

Exposures: Self-reported obstructive sleep apnea, billing diagnosis of obstructive sleep apnea, or STOP-BANG (Snoring, Tiredness, Observed Apnea, Blood Pressure, Body Mass Index, Age, Neck Circumference and Gender) questionnaire score greater than 4, as well as self-reported use of preoperative positive airway pressure.

Main Outcomes And Measures: Delirium within 7 days of surgery.

Results: A total of 7792 patients (4562 men; mean [SD] age, 59.2 [15.3] years) met inclusion criteria. Diagnosed or likely obstructive sleep apnea occurred in 2044 patients (26%), and delirium occurred in 3637 patients (47%). The proportion of patients with incident delirium was lower among those with obstructive sleep apnea than those without (897 of 2044 [44%] vs 2740 of 5748 [48%]; unadjusted risk difference, -0.04; 99% credible interval [CrI], -0.07 to -0.00). Positive airway pressure adherence had minimal association with delirium (risk difference, -0.00; 99% CrI, -0.09 to 0.09). Doubly robust confounder adjustment eliminated the association between obstructive sleep apnea and delirium (risk difference, -0.01; 99% CrI, -0.04 to 0.03) and did not change that of preoperative positive airway pressure adherence (risk difference, -0.00, 99% CrI, -0.07 to 0.07). The results were consistent across multiple sensitivity analyses.

Conclusions And Relevance: After risk adjustment, this study found no association between obstructive sleep apnea and postoperative delirium in the context of usual care in the intensive care unit, with 99% CrIs excluding clinically meaningful associations. With limited precision, no association was found between positive airway pressure adherence and delirium. Selection bias and measurement error limit the validity and generalizability of these observational associations; however, they suggest that interventions targeting sleep apnea and positive airway pressure are unlikely to have a meaningful association with postoperative intensive care unit delirium.
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http://dx.doi.org/10.1001/jamanetworkopen.2020.3125DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7171553PMC
April 2020

A Factored Generalized Additive Model for Clinical Decision Support in the Operating Room.

AMIA Annu Symp Proc 2019 4;2019:343-352. Epub 2020 Mar 4.

Department of Computer Science and Engineering, Washington University in St Louis, St Louis, MO.

Logistic regression (LR) is widely used in clinical prediction because it is simple to deploy and easy to interpret. Nevertheless, being a linear model, LR has limited expressive capability and often has unsatisfactory performance. Generalized additive models (GAMs) extend the linear model with transformations of input features, though feature interaction is not allowed for all GAM variants. In this paper, we propose a factored generalized additive model (F-GAM) to preserve the model interpretability for targeted features while allowing a rich model for interaction with features fixed within the individual. We evaluate F-GAM on prediction of two targets, postoperative acute kidney injury and acute respiratory failure, from a single-center database. We find superior model performance of F-GAM in terms of AUPRC and AUROC compared to several other GAM implementations, random forests, support vector machine, and a deep neural network. We find that the model interpretability is good with results with high face validity.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7153157PMC
July 2020

The Unbearableness of Being Light.

Anesth Analg 2020 09;131(3):977-980

From the Department of Anesthesiology, Washington University School of Medicine, St Louis, Missouri.

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http://dx.doi.org/10.1213/ANE.0000000000004814DOI Listing
September 2020

A roadmap to advance delirium research: Recommendations from the NIDUS Scientific Think Tank.

Alzheimers Dement 2020 05 14;16(5):726-733. Epub 2020 Apr 14.

Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School, Boston, Massachusetts, USA.

Delirium is an acute disorder of attention and cognition. It occurs across the life span, yet it is particularly common among older adults, and is closely linked with underlying neurocognitive disorders. Evidence is mounting that intervening on delirium may represent an important opportunity for delaying the onset or progression of dementia. To accelerate the current understanding of delirium, the Network for Investigation of Delirium: Unifying Scientists (NIDUS) held a conference "Advancing Delirium Research: A Scientific Think Tank" in June 2019. This White Paper encompasses the major knowledge and research gaps identified at the conference: advancing delirium definition and measurement, understanding delirium pathophysiology, and prevention and treatment of delirium. A roadmap of research priorities is proposed to advance the field in a systematic, interdisciplinary, and coordinated fashion. A call is made for an international consortium and biobank targeted to delirium, as well as a public health campaign to advance the field.
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http://dx.doi.org/10.1002/alz.12076DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7317361PMC
May 2020

A Qualitative Study of Perioperative Depression and Anxiety in Older Adults.

Am J Geriatr Psychiatry 2020 10 2;28(10):1107-1118. Epub 2020 Mar 2.

Department Anesthesiology of (JA, AM, TK, MSA), School of Medicine, Washington University, St. Louis, MO.

Objective: We had three aims 1) understand barriers to perioperative management of anxiety and depression in older surgical patients; 2) identify preferences and requirements for interventions to manage their anxiety and depression; and 3) explore the feasibility of implementing such interventions in perioperative care.

Design: A qualitative study using semistructured interviews was conducted.

Setting: Participants were recruited at a large academic medical center.

Participants: We interviewed older surgical patients and clinicians to characterize their perspectives on management of anxiety and depression symptoms, with emphasis on patient needs, barriers, and potential interventions to address these needs.

Measurements: We used the Consolidated Framework for Intervention Research to guide the development of interview questions related to intervention implementation feasibility. Thematic analysis was used to analyze interview responses.

Results: Forty semistructured interviews were conducted. Key barriers for perioperative management of depression and anxiety included fear of surgery, acute pain, postoperative neurocognitive disorders, limited understanding of what to expect regarding surgery and recovery, and overwhelmingly complex medication management. Patients and clinicians suggested that a bundled mental health management intervention targeted for older surgical patient population comprised of behavioral and pharmacologic strategies can help mitigate anxiety and depression symptoms during the perioperative period. Clinicians emphasized the need for a collaborative engagement strategy that includes multiple stakeholders in the design, planning, and implementation of such an intevention.

Conclusion: New care models need to be developed to integrate mental health care into the current perioperative care practice.
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http://dx.doi.org/10.1016/j.jagp.2020.02.010DOI Listing
October 2020