Citations

OBJECTIVES: There is a paucity of literature regarding administrative approvals required for clinical studies during a pandemic. We aimed to evaluate variation in duration of administrative approvals within the Viral Infection and Respiratory illness Universal Study (VIRUS): A Global COVID-19 Registry. DESIGN, SETTING, AND SUBJECTS: Survey analysis of 188 investigators who participated in the VIRUS: COVID-19 registry, a prospective, observational global registry database of 287 sites. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: For each study site approved through December 8, 2020, we assessed the duration in days: 1) from institutional review board (IRB) submission to IRB approval, 2) from IRB approval to Research Electronic Data Capture (REDCap) access, 3) from REDCap access to first patient data entry in REDCap, and 4) total duration from IRB submission to first patient data entry in REDCap. Analysis of variance and Wilcoxon rank-sum test were used to compare time durations. Of 287 sites, 188 sites (United States = 155, non-United States = 33) provided complete administrative data. There was considerable variability in duration from IRB submission to first patient data entry with median (interquartile range) of 28 days (16–50 d), with differences not significantly different by country (United States: 30 [17–50] vs non-United States: 23 d [8–46 d]; p = 0.08) or previous “multisite trial experience” (experienced: 27 [15–51] vs not experienced: 29 d [13–47 d]; p = 0.67). The U.S. sites had a higher proportion of female principal investigators (n = 77; 50%), compared with non-U.S. sites (n = 7; 21%; p = 0.002). Non-U.S. sites had a significantly shorter time to first patient data entry after REDCap access: 7 (1–28) versus 3 days (1–6 d) (p = 0.02). CONCLUSIONS: In this Society of Critical Care Medicine global VIRUS: COVID-19 Registry, we identified considerable variability in time from IRB submission to first patient data entry with no significant differences by country or prior multicenter trial experience. However, there was a significant difference between US and non-U.S. sites in the time from REDCap access to first data entry.

In this qualitative study, we explored perspectives of patients in the intensive care unit (ICU) and their families on the Get to Know Me board (GTKMB). Of the 46 patients approached, 38 consented to participate. Of the 66 family members approached, 60 consented to participate. Most patients (26, 89%) and family members (52, 99%) expressed that GTKMB was important in recognizing patient's humanity. Most patients (20, 68%) and families (39, 74%) said that it helped to build a better relationship with the provider team. 60% of patients and families commented that the GTKMB was used as a platform by providers to interact with them. Up to 45 (85%) of the family members supported specific contents of the GTKMB. In structured interviews (11 patients, 7 family members), participants additionally commented on ways providers used the GTKMB to communicate, support patient's personhood, and on caveats in interacting with GTKMB. Critically ill patients and families found the GTKMB helpful in preserving personhood of patient, fostering communication, and building relationships with clinicians.

ABSTRACT Background: Although central venous oxygen saturation (ScvO2) has been used as an endpoint for the treatment of circulatory shock, its role in guiding the evaluation and treatment of patients with severe hypoxemia remains to be assessed. The aim of this study was to assess the incidence of low ScvO2 in a cohort of hypoxemic patients and the association of this finding with differences in clinical management and patient outcomes. Methods: Retrospective review of data from adult intensive care unit patients with hypoxemia who required invasive mechanical ventilation for over 24 h and had at least one ScvO2 measured within 6 h of a PaO2/FiO2 ratio <200. Results: Of 442 mechanically ventilated patients with severe hypoxemia, 249 (56%) had an ScvO2 <70%. When compared with patients with ScvO2 ≥70%, those with low ScvO2 had worse systemic oxygenation and hemodynamic parameters and were more likely to receive red blood cell transfusions (31.7% vs. 18.1%, P = 0.001), epinephrine (27.3% vs. 16.6%, P = 0.007), and inodilators. Outcomes such as median intensive care unit length of stay (7.5 vs. 8.3 days, P = 0.337) and hospital mortality (39.8% vs. 35.7%, P = 0.389) were not different between groups. When stratified by the central venous-to-arterial CO2 difference (∆PCO2), patients with a low ScvO2 and normal ∆PCO2 had lower median PaO2 and hemoglobin levels and received more red blood cell transfusions, whereas those with an increased ∆PCO2 had a lower pulse pressure and cardiac index and were more likely to receive epinephrine and milrinone. Conclusion: Low ScvO2 is frequently observed in mechanically ventilated patients with severe hypoxemia, and these patients receive different interventions. Clinicians often use therapies targeting systemic oxygen delivery to correct low ScvO2. Prospective research is needed to identify patients with severe hypoxemia that might benefit from interventions targeting systemic oxygen delivery.

AbstractBackgroundPneumocystis pneumonia (PCP) is a growing concern as the immunocompromised population expands. Current laboratory approaches are limited. This systematic review aimed to evaluate metagenomic next-generation sequencing (MNGS) tests’ performance in detecting PCP.MethodsFive databases were searched through December 19, 2022, to identify original studies comparing MNGS with clinically diagnosed PCP. To assess the accuracy, symmetric hierarchical summary receiver operating characteristic models were used.ResultsEleven observational studies reporting 1442 patients (424 with PCP) were included. Six studies focused exclusively on recipients of biologic immunosuppression (none with HIV-associated immunosuppression). Six were exclusively on bronchoalveolar lavage, while 1 was on blood samples. The sensitivity of MGNS was 0.96 (95% CI, 0.90–0.99), and specificity was 0.96 (95% CI, 0.92–0.98), with negative and positive likelihood ratios of 0.02 (95% CI, 0.01–0.05) and 19.31 (95% CI, 10.26–36.36), respectively. A subgroup analysis of studies exclusively including bronchoalveolar lavage (BAL) and blood samples demonstrated a sensitivity of 0.94 (95% CI, 0.78–0.99) and 0.93 (95% CI, 0.80–0.98) and a specificity of 0.96 (95% CI, 0.88–0.99) and 0.98 (95% CI, 0.76–1.00), respectively. The sensitivity analysis on recipients of biologic immunosuppression showed a sensitivity and specificity of 0.96 (95% CI, 0.90–0.98) and 0.94 (95% CI, 0.84–0.98), respectively. The overall confidence in the estimates was low.ConclusionsDespite the low certainty of evidence, MNGS detects PCP with high sensitivity and specificity. This also applies to recipients of biologic immunosuppression and tests performed exclusively on blood samples without the need for BAL. Further studies are required in individuals with HIV-associated immunosuppression.

Objectives Patient safety incident reporting in our institution’s intensive care units (ICUs) had fallen 30% below national benchmarks during the COVID-19 pandemic. Underreporting diminishes awareness of risks and precludes organizational learning from near misses. We aimed to increase the ICU number of patient safety incident reports by 30% from 27 to 35 reports/1000 patient-days without negatively impacting culture of safety as measured by patient-care staff surveys. Methods Single-institution prospective interventional study with 9 ICUs receiving a multifaceted intervention developed using quality improvement methodology during February–April 2022. Study intervention involved creation of patient safety peer-leadership role, feedback process, interactive dashboards for patient safety data, and education resources accessible via quick response codes. Primary outcome was patient safety incident reports/1000 patient-days. Intensive care unit patient-care staff culture of safety was assessed with surveys. Results Intensive care unit patient safety incident reporting increased by 48% after intervention (40 versus 27 reports/1000 patient-days [P = 0.136]). Near misses were the most common incident report. Intensive care unit patient-care staff ratings of patient safety did not change; 80% rated patient safety as good or better after intervention versus 78% at baseline (P = 0.465). However, significant improvement was observed for subcomponents related to learning culture and support for staff involved in patient safety incidents. Most reports (>80%) were submitted by nurses. Conclusions This multifaceted quality improvement intervention increased patient safety incident reporting in the ICUs. Increases in ratings of learning culture and support for staff underline the importance of a well-functioning patient safety incident reporting system in an institutional culture of safety.

Background: Patients with pulmonary hypertension (PH) who undergo endotracheal intubation have an increased risk of adverse outcomes, but little is known regarding prognostic factors and there is limited evidence to guide management. We sought to define characteristics, prognostic factors, and outcomes of critically ill patients with PH who underwent intubation. Study Design: We performed a single-center retrospective cohort study of critically ill patients with group 1, 3 or 4 PH who underwent intubation. Results: Eighty-one patients were included. Patients had a median age of 56 years (interquartile range 44-65) and were predominantly female (n = 53, 65%) and Caucasian (n = 71, 88%). Forty-five (56%) had group 1 PH while 25 (31%) had group 3 PH and 11 (14%) had group 4 PH. Patients were admitted to the hospital for right ventricular failure (n = 21, 25.6%), sepsis (n = 18, 22.2%), and respiratory failure (n = 19, 23.1%). Hypoxemic respiratory failure (n = 54, 66.7%) was the most common indication for intubation. In-hospital mortality was 30.9% and 1-year mortality was 48.2% . All patients (11 of 11, 100%) intubated electively for intensive care unit procedures survived to hospital discharge while only 1 of 6 (16.7%) intubated in the setting of a cardiac arrest survived. After adjusting for right ventricular systolic pressure, pre-intubation PaO 2 (odds ratio [OR] = 0.99, 95% confidence interval [CI] 0.97-1.00, P = .02) and postintubation PaO 2 (OR = 0.97 per 1mm Hg, 95% CI 0.95 to 0.99, P = .003), pH (OR = 0.49 per 0.1 increase, 95% CI 0.29 to 0.80, P = .005) and PaCO 2 (OR = 1.08 per 1mm Hg, 95% CI 1.02 to 1.14, P = .005) were significantly associated with in-hospital mortality. Results were similar when we excluded patients intubated electively or in the setting of cardiac arrest. Conclusions: Intubation in critically ill patients with PH is associated with significant in-hospital mortality and nearly 50% 1-year mortality. Potentially modifiable factors, such as peri-intubation gas exchange, are associated with an increased risk of death while other demographic and hemodynamic variables are not.

Abstract Background and Aims Acute kidney injury (AKI) is associated with an increased risk of progression to a severe form in every disease and, moreover, is associated with an increased mortality, and so it is also with coronavirus disease 2019 (COVID-19). AKI is a frequent complication in COVID-19 patients admitted to ICU for severe respiratory failure. ICU treatment itself indirectly could cause or exacerbate renal damage, through suboptimal fluid management, drug toxicity, or low human resources. The aims of this study were to assess AKI prevalence, fluid balance and glomerular filtration rate as a predictor of outcome in COVID-19 patients treated in the intensive care unit. Method We retrospectively analysed all adult patients admitted to the ICU at a regional hospital in northern Bavaria, from 1st March to 31st December 2020. Clinical data and laboratory results were retrospectively retrieved from the hospital information system and electronic case files. According to the severity of AKI based on the KDIGO criteria, and laboratory values were followed on the first 7 days on the ICU. In total 320 patients patients were included in the study. Level of significance was set to p&lt;0.05. Results The mean age was 65 ± 19 years, 135 (42%) patients were females, 185 (58%) were males. Median length of ICU stay was 7 (2-13 days) in females, and 8 days (4- to 21 days) in males. At the ICU, 177 patients needed some form of ventilation, from which 109 (needed Invasive mechanical ventilation). During ICU stay, 81 patients have died, with fatality rate of 25%. Patients with AKI (n=48, 15%) at the admission to the ICU, had 2.1 times higher risk of death at the ICU than patients without AKI. There was a statistically significant difference in ICU survival based on a glomerular filtration rate, fluid balance, CRP and leukocyte values, F=1.957, p=0.026; Wilk's Λ=0.724, partial η2 = 0.276 Conclusion Acute kidney injury is common in coronavirus disease 2019, and it is associated with poor clinical outcomes. Even first couple of days at the ICU could point to the outcome, with markers of inflammation, glomerular filtration rate, and fluid balance being most valuable variables.

IMPORTANCE: Initial Society of Critical Care Medicine Discovery Viral Infection and Respiratory illness Universal Study (VIRUS) Registry analysis suggested that improvements in critical care processes offered the greatest modifiable opportunity to improve critically ill COVID-19 patient outcomes. OBJECTIVES: The Structured Team-based Optimal Patient-Centered Care for Virus COVID-19 ICU Collaborative was created to identify and speed implementation of best evidence based COVID-19 practices. DESIGN, SETTING, AND PARTICIPANTS: This 6-month project included volunteer interprofessional teams from VIRUS Registry sites, who received online training on the Checklist for Early Recognition and Treatment of Acute Illness and iNjury approach, a structured and systematic method for delivering evidence based critical care. Collaborators participated in weekly 1-hour videoconference sessions on high impact topics, monthly quality improvement (QI) coaching sessions, and received extensive additional resources for asynchronous learning. MAIN OUTCOMES AND MEASURES: Outcomes included learner engagement, satisfaction, and number of QI projects initiated by participating teams. RESULTS: Eleven of 13 initial sites participated in the Collaborative from March 2, 2021, to September 29, 2021. A total of 67 learners participated in the Collaborative, including 23 nurses, 22 physicians, 10 pharmacists, nine respiratory therapists, and three nonclinicians. Site attendance among the 11 sites in the 25 videoconference sessions ranged between 82% and 100%, with three sites providing at least one team member for 100% of sessions. The majority reported that topics matched their scope of practice (69%) and would highly recommend the program to colleagues (77%). A total of nine QI projects were initiated across three clinical domains and focused on improving adherence to established critical care practice bundles, reducing nosocomial complications, and strengthening patient- and family-centered care in the ICU. Major factors impacting successful Collaborative engagement included an engaged interprofessional team; an established culture of engagement; opportunities to benchmark performance and accelerate institutional innovation, networking, and acclaim; and ready access to data that could be leveraged for QI purposes. CONCLUSIONS AND RELEVANCE: Use of a virtual platform to establish a learning collaborative to accelerate the identification, dissemination, and implementation of critical care best practices for COVID-19 is feasible. Our experience offers important lessons for future collaborative efforts focused on improving ICU processes of care.

Background Although corticosteroids have become the standard of care for patients with coronavirus disease-2019 (COVID-19) on supplemental oxygen, there is growing evidence of differential treatment response. This study aimed to evaluate if there was an association between biomarker-concordant corticosteroid treatment and COVID-19 outcomes. Methods This registry-based cohort study included adult COVID-19 hospitalized patients between January 2020 and December 2021 from 109 institutions. Patients with available C-reactive protein (CRP) levels within 48 h of admission were evaluated. Those on steroids before admission, stayed in the hospital for <48 h, or were not on oxygen support were excluded. Corticosteroid treatment was biomarker-concordant if given with high baseline CRP ≥150 mg/L or withheld with low CRP (<150 mg/L) and vice-versa was considered discordant (low CRP with steroids, high CRP without steroids). Hospital mortality was the primary outcome. Sensitivity analyses were conducted using varying CRP level thresholds. The model interaction was tested to determine steroid effectiveness with increasing CRP levels. Results Corticosteroid treatment was biomarker-concordant in 1778 (49%) patients and discordant in 1835 (51%). The concordant group consisted of higher-risk patients than the discordant group. After adjusting for covariates, the odds of in-hospital mortality were significantly lower in the concordant group than the discordant (odds ratio [95% confidence interval (C.I.)] = 0.71 [0.51, 0.98]). Similarly, adjusted mortality difference was significant at the CRP thresholds of 100 and 200 mg/L (odds ratio [95% C.I.] = 0.70 [0.52, 0.95] and 0.57 [0.38, 0.85], respectively), and concordant steroid use was associated with lower need for invasive ventilation for 200 mg/L threshold (odds ratio [95% C.I.] = 0.52 [0.30, 0.91]). In contrast, no outcome benefit was observed at CRP threshold of 50. When the model interaction was tested, steroids were more effective at reducing mortality as CRP levels increased. Conclusion Biomarker-concordant corticosteroid treatment was associated with lower odds of in-hospital mortality in severe COVID-19.