Janelle M. Fine

Background/Objectives: The COVID-19 pandemic highlighted the limitations of pulse oximetry in detecting occult hypoxemia. The superiority of the alveolar gas monitor (AGM) compared to pulse oximetry (SpO₂) in predicting respiratory deterioration among COVID-19-positive individuals has previously been demonstrated. Here, we combine COVID-19 and non-COVID-19 individuals as a combined cohort of participants to determine if the AGM has similar utility across a larger, more generalizable cohort. Methods: Adult patients (n = 75) at risk of respiratory deterioration in the emergency department (ED) underwent prospective assessments of their oxygen deficit (OD) and SpO₂, simultaneously measured during quiet breathing on the AGM. The OD and SpO₂ were then compared for their ability to predict the dichotomous outcome of the need for supplemental oxygen. The administration of supplemental oxygen was ordered by the clinical care team with no knowledge of the patients’ enrollment in this study. Results: In the logistic regression analysis, both SpO₂ and OD significantly predicted the need for supplemental oxygen among COVID-19-negative individuals. However, in the multivariable regression, only OD (p < 0.001) significantly predicted the need for supplemental oxygen, while SpO₂ (p = 0.05) did not in the combined cohort of COVID-19-negative and -positive individuals. Receiver operating characteristic (ROC) curve analysis demonstrated the superior discriminative ability of OD (area under ROC curve = 0.937) relative to SpO₂ (area under ROC curve = 0.888) to predict the need for supplemental oxygen. Conclusions: The noninvasive AGM, which combines the measurement of exhaled partial pressures of gas with SpO₂, outperforms SpO₂ alone in predicting the need for supplemental oxygen among individuals in the ED at risk of respiratory deterioration regardless of the etiology for their symptoms (COVID-19-positive or -negative).

Rapid portable assays are needed to improve diagnosis, treatment, and reduce transmission of tuberculosis (TB), but current tests are not suitable for patients in resource-limited settings with high TB burden. Here we report a low complexity, lab-in-tube system that is read by an integrated handheld device that detects Mycobacterium tuberculosis ( Mtb ) DNA in blood and respiratory samples from a variety of clinical settings. This microprocessor-controlled device uses an LCD user interface to control assay performance, automate assay analysis, and provide results in a simple readout. This point-of-care single-tube assay uses a DNA enrichment membrane and a low-cost cellulose disc containing lyophilized recombinase polymerase amplification and CRISPR-Cas12a reagents to attain single-nucleotide specificity and high sensitivity within 1 hour of sample application, without a conventional DNA isolation procedure. Assay results obtained with serum cell–free DNA isolated from a cohort of children aged 1 to 16 years detected pulmonary and extrapulmonary TB with high sensitivity versus culture and GeneXpert MTB/RIF results (81% versus 55% and 68%) and good specificity (94%), meeting the World Health Organization target product profile criteria for new nonsputum TB diagnostics. Changes in assay results for serum isolated during treatment were also highly predictive of clinical response. Results obtained with noninvasive sputum and saliva specimens from adults with bacteriologically confirmed pulmonary TB were also comparable to those reported for reference methods. This rapid and inexpensive lab-in-tube assay approach thus represents one means to address the need for point-of-care TB diagnostics useable in low-resource settings.

The intensive care unit (ICU) environment is designed for the care of acutely ill patients, with lighting conditions reflecting the needs of the busy clinical setting. Earlier ICU studies suggested that daytime and nighttime light levels were misaligned with those required for circadian rhythm entrainment, which can impact patient sleep-wake cycles and recovery from critical illness. In this investigation in San Diego, California, a coastal US city with over 260 days of sunshine annually, we performed a detailed evaluation of light levels in a contemporary academic medical-surgical ICU constructed in 2016, which features modern lighting and floor-to-ceiling windows in each of the 24 rooms. Using light meters mounted on poles and located directly behind the head of each patient's bed, our analysis of nearly 90,000 hours of data revealed daytime ICU light levels consistently lower than 150 lx, similar to studies in older ICUs and many magnitudes lower than outdoor levels at identical times. Hence, despite the modern design, we found that little to no light from the ~100 ft² windows reached the patient. While daytime light levels were low across all ICU rooms, those with windows facing South and Northwest featured higher light levels than those facing Southeast and Northeast, suggesting a contribution of window direction to ICU light levels.

Background/Objectives: Although delirium is common during critical illness, standard-of-care detection and prevention practices in real-world intensive care unit (ICU) settings remain inconsistent, often due to a lack of provider education. Despite availability for over 20 years of validated delirium screening tools such as the Confusion Assessment Method in the ICU (CAM-ICU), feasible and rigorous educational efforts continue to be needed to address persistent delirium standard-of-care practice gaps. Methods: Spanning an 8-month quality improvement project period, our single-ICU interdisciplinary effort involved delivery of CAM-ICU pocket cards to bedside nurses, and lectures by experienced champions that included a live delirium detection demonstration using the CAM-ICU, and a comprehensive discussion of evidence-based delirium prevention strategies (e.g., benzodiazepine avoidance). Subsequent engagement by health system leadership motivated the development of an electronic health record dataset to evaluate unit-level outcomes, including CAM-ICU documentation and benzodiazepine administration. Results: Using a dataset that spanned 9 pre- and 37 post-project months and included 3612 patients, 4470 admissions, and 33,913 patient days, we observed that delirium education was followed by a dramatic rise in CAM-ICU documentation, from p < 0.0001 for trend), and a fall in the proportion of mechanically ventilated patients ever receiving benzodiazepine infusions (69% to 41%; p < 0.0001). Conclusions: An interdisciplinary delirium project comprising rigorous lectures on standard-of-care practices can yield significant improvements in documentation and sedative administration. This approach can help ICUs jumpstart efforts to build awareness and address longstanding gaps in standard-of-care delirium practices.

Background and Objective: The COVID-19 pandemic magnified the importance of gas exchange abnormalities in early respiratory failure. Pulse oximetry (SpO₂) has not been universally effective for clinical decision-making, possibly because of limitations. The alveolar gas monitor (AGM100) adds exhaled gas tensions to SpO₂ to calculate the oxygen deficit (OD). The OD parallels the alveolar-to-arterial oxygen difference (AaDO₂) in outpatients with cardiopulmonary disease. We hypothesized that the OD would discriminate between COVID-19 patients who require hospital admission and those who are discharged home, as well as predict need for supplemental oxygen during the index hospitalization. Methods: Patients presenting with dyspnea and COVID-19 were enrolled with informed consent and had OD measured using the AGM100. The OD was then compared between admitted and discharged patients and between patients who required supplemental oxygen and those who did not. The OD was also compared to SpO₂ for each of these outcomes using receiver operating characteristic (ROC) curves. Results: Thirty patients were COVID-19 positive and had complete AGM100 data. The mean OD was significantly (p = 0.025) higher among those admitted 50.0 ± 20.6 (mean ± SD) vs. discharged 27.0 ± 14.3 (mean ± SD). The OD was also significantly (p < 0.0001) higher among those requiring supplemental oxygen 60.1 ± 12.9 (mean ± SD) vs. those remaining on room air 25.2 ± 11.9 (mean ± SD). ROC curves for the OD demonstrated very good and excellent sensitivity for predicting hospital admission and supplemental oxygen administration, respectively. The OD performed better than an SpO₂ threshold of <94%. Conclusions: The AGM100 is a novel, noninvasive way of measuring impaired gas exchange for clinically important endpoints in COVID-19.

Background: Mechanically ventilated Intensive Care Unit (ICU) patients often require wrist restraints, contributing to immobility and agitation, over-sedation, and delirium. The Exersides® Refraint® (Healthy Design, LLC), a novel restraint alternative, may be safe and facilitate greater mobility than traditional restraints. Objective: This National Institutes of Health Small Business Technology Transfer (STTR) Program Grant-funded single-site Phase I feasibility study evaluated Exersides® safety and feasibility in anticipation of a multi-site Phase II randomized controlled trial (RCT). Methods: In two academic ICUs, mechanically ventilated adults ⩾25 years old who were non-comatose, required restraints and had an expected stay of ⩾2 days were enrolled to wear Exersides® and traditional wrist restraints for 4 h on day 1, in a randomized order, and in the reverse order on day 2. Main outcomes were Exersides® safety (i.e., patient/clinician lacerations/injuries), feasibility (i.e., ⩾90% of required data collected), and patient/family/clinician feedback. Results: Eight patients were enrolled; one no longer required restraints at initiation, yielding seven subjects (median [interquartile range (IQR)] age 65 [55, 70] years, 86% men). All seven wore Exersides®, averaging (SD) 2.5 (1.0) hours per session, with no safety events reported. Across restraint time periods, 92% and 100% of Richmond Agitation-Sedation Scale (RASS) and wrist actigraphy data, respectively, were collected. Feedback was positive (more movement and comfortable than traditional restraints) and constructive (bulky, intimidating to apply). Conclusions: This pilot study provided key safety and feasibility data for a Phase II RCT evaluating Exersides® versus traditional wrist restraints. Feedback motivated minor device modifications before RCT initiation.