Kashyap, Rahul

BACKGROUND: Liberal oxygenation during mechanical ventilation is harmful in critically ill patients and in certain subsets of patients, including those with stroke, acute myocardial infarction, and cardiac arrest. Surveillance through electronic medical records improves safety of mechanical ventilation in the ICU. To date, this practice has not been used for oxygen titration ( F IO 2 ) in adults. We hypothesize that a surveillance system based on the electronic medical record to alert respiratory therapists to titrate F IO 2 is feasible, safe, and efficacious. METHODS: In this pilot study, mechanically ventilated subjects were randomized to respiratory therapist-driven F IO 2 titration after an electronic alert versus standard of care (ie, titration based on physician order). An automated surveillance system utilizing a hyperoxemia-detection algorithm generated an electronic alert to a respiratory therapist’s pager. Hyperoxemia was defined as F IO 2 > 0.5 and S pO 2 > 95% for > 30 min. No other aspects of treatment were changed. We assessed feasibility, safety, and preliminary efficacy. Primary outcome was duration of hyperoxemia during mechanical ventilation. An unsafe outcome was identified as hypoxemia ( S pO 2 < 88%) within 1 h after titration per alert. Feasibility was assessed by a survey of respiratory therapists. RESULTS: Of 226 randomized subjects, 31 were excluded (eg, programming errors of the electronic alerts, no consent, physician discretion). We included 195 subjects, of whom 86 were in the intervention arm. Alert accuracy was 78%, and respiratory therapists responded to 64% of the alerts. During mechanical ventilation, exposure to hyperoxemia significantly decreased in the intervention group (median 13.5 h [interquartile range 6.2–29.4] vs 18.8 h [interquartile range 9.6–37.4]). No episodes of significant hypoxemia were registered. Most respiratory therapists agreed that the alert was helpful in reducing excessive oxygen exposure. CONCLUSIONS: Use of an electronic surveillance system to titrate F IO 2 was safe and feasible and showed preliminary efficacy in reducing hyperoxemia. Our study serves to justify larger randomized controlled trials for F IO 2 titration.

Objectives: Use of observational data to inform the response and care of patients during a pandemic faces unique challenges. Design: The Society of Critical Care Medicine Discovery Viral Infection and Respiratory Illness Universal Study COVID 2019 Registry Core data and research methodology team convened over virtual meetings throughout March to June 2020 to determine best practice goals for development of a pandemic disease registry to support rapid data collection and analysis. Setting: International, multi-center registry of hospitalized patients. Patients: None. Interventions: None. Measurements and Main Results: Large-scale observational data collection requires: 1) quality assurance and harmonization across many sites; 2) a transparent process for selecting from among many potential research questions; 3) the use of best practices in design of descriptive, predictive, and inferential studies; (4) innovative approaches to characterize random error in the setting of constantly updated data; (5) rapid peer-review and reporting; and (6) transitions from a focus on discovery to implementation. Herein, we describe the guiding principles to best practices and suggestions for innovations to study design and reporting within the coronavirus disease 2019 Viral Infection and Respiratory Illness Universal Study pandemic registry. Conclusions: Society of Critical Care Medicine Discovery Viral Infection and Respiratory Illness Universal Study coronavirus disease 2019 registry sought to develop and implement prespecified best practices combined with grassroots efforts from clinical sites worldwide in order to develop clinically useful knowledge in response to a pandemic.

ABSTRACT Background Implementation of checklists has been shown to be effective in improving patient safety. This study aims to evaluate the effectiveness of implementation of a checklist for daily care processes into clinical practice of pediatric intensive care units (PICUs) with limited resources. Methods Prospective before–after study in eight PICUs from China, Congo, Croatia, Fiji, and India after implementation of a daily checklist into the ICU rounds. Results Seven hundred and thirty-five patients from eight centers were enrolled between 2015 and 2017. Baseline stage had 292 patients and post-implementation 443. The ICU length of stay post-implementation decreased significantly [9.4 (4–15.5) vs. 7.3 (3.4–13.4) days, p = 0.01], with a nominal improvement in the hospital length of stay [15.4 (8.4–25) vs. 12.6 (7.5–24.4) days, p = 0.055]. The hospital mortality and ICU mortality between baseline group and post-implementation group did not show a significant difference, 14.4% vs. 11.3%; p = 0.22 for each. There was a variable impact of checklist implementation on adherence to various processes of care recommendations. A decreased exposure in days was noticed for; mechanical ventilation from 42.6% to 33.8%, p &lt; 0.01; central line from 31.3% to 25.3%, p &lt; 0.01; and urinary catheter from 30.6% to 24.4%, p &lt; 0.01. Although there was an increased utilization of antimicrobials (89.9–93.2%, p &lt; 0.01). Conclusions Checklists for the treatment of acute illness and injury in the PICU setting marginally impacted the outcome and processes of care. The intervention led to increasing adherence with guidelines in multiple ICU processes and led to decreased length of stay.

Objectives: The coronavirus disease 2019 pandemic has disproportionally strained intensive care services worldwide. Large areas of uncertainly regarding epidemiology, physiology, practice patterns, and resource demands for patients with coronavirus disease 2019 require rapid collection and dissemination of data. We describe the conception and implementation of an intensive care database rapidly developed and designed to meet data analytic needs in response to the coronavirus disease 2019 pandemic—the multicenter, international Society of Critical Care Medicine Discovery Network Viral Infection and Respiratory Illness Universal Study. Design: Prospective cohort study and disease registry. Setting: Multinational cohort of ICUs. Patients: Critically ill patients with a diagnosis of coronavirus disease 2019. Interventions: None. Measurements and Main Results: Within 2 weeks of conception of the Society of Critical Care Medicine Discovery Network Viral Infection and Respiratory Illness Universal Study, study leadership was convened, registry case report forms were designed, electronic data entry set up, and more than 250 centers had submitted the protocol for institutional review board approval, with more than 100 cases entered. Conclusions: The Society of Critical Care Medicine Discovery Network Viral Infection and Respiratory Illness Universal Study provides an example of a rapidly deployed, international, pandemic registry that seeks to provide near real-time analytics and information regarding intensive care treatments and outcomes for patients with coronavirus disease 2019.

Abstract Background: The Checklist for Early Recognition and Treatment of Acute Illness and Injury (CERTAIN) study is a before-and-after clinical quality improvement study involving 20 countries. Our aim was to describe the challenges and solutions for study implementation across various intensive care units.Methods: After local institutional review board approval, each study center had a setup period before patient data were collected. Each center was required to accomplish 4 stages: baseline data collection, remote simulation training, local implementation, and postimplementation data collection and maintenance of process of care. We measured the time required to complete each study stage and used the Define, Measure, Analyze, Improve, and Control (DMAIC) framework to identify the challenges encountered during each stage and guide improvement strategies to facilitate implementation of CERTAIN.Results: Between June 2012 and December 2017, 55 centers from 20 countries were recruited to participate. The time to complete each stage at different centers varied significantly. The most common domains in which challenges occurred were 1) leadership support and team building, 2) communication, 3) work environment culture, 4) language barriers, 5) infrastructure and technology, and 6) sustainability. Obstacles in these 6 areas delayed reaching major milestones of the study. Different strategies were deployed to overcome these barriers: engaging leadership for support, using native-speaking clinicians during training sessions, using various communication platforms, providing personal computers to local hospitals, making in-person site visits, offering flexible training time, and supporting local centers’ grant applications. Centers that enrolled during the control phase, compared with those that enrolled earlier, had significantly shorter times and less variation in times for each study stage and for the total study time.Conclusions: By using the DMAIC method, we identified the predominant 6 domains in which challenges occurred during implementation of the global CERTAIN study and developed targeted strategies to overcome the challenges and shorten the duration of the study. The DMAIC method would be useful in improving the efficiency of other large-scale multinational quality improvement projects.