6 research outputs found
Awareness with paralysis and symptoms of post-traumatic stress disorder among mechanically ventilated emergency department survivors (ED-AWARENESS-2 Trial): study protocol for a pragmatic, multicenter, stepped wedge cluster randomized trial.
BACKGROUND: Awareness with paralysis (AWP) is memory recall during neuromuscular blockade (NMB) and can cause significant psychological harm. Decades of effort and rigorous trials have been conducted to prevent AWP in the operating room, where prevalence is 0.1-0.2%. By contrast, AWP in mechanically ventilated emergency department (ED) patients is common, with estimated prevalence of 3.3-7.4% among survivors given NMB. Longer-acting NMB use is a critical risk for AWP, and we have shown an association between ED rocuronium use and increased AWP prevalence. As NMB are given to more than 90% of ED patients during tracheal intubation, this trial provides a platform to test an intervention aimed at reducing AWP. The overall objective is to test the hypothesis that limiting ED rocuronium exposure will significantly reduce the proportion of patients experiencing AWP.
METHODS: This is a pragmatic, stepped wedge cluster randomized trial conducted in five academic EDs, and will enroll 3090 patients. Per the design, all sites begin in a control phase, under observational conditions. At 6-month intervals, sites sequentially enter a 2-month transition phase, during which we will implement the multifaceted intervention, which will rely on use of nudges and defaults to change clinician decisions regarding ED NMB use. During the intervention phase, succinylcholine will be the default NMB over rocuronium. The primary outcome is AWP, assessed with the modified Brice questionnaire, adjudicated by three independent, blinded experts. The secondary outcome is the proportion of patients developing clinically significant symptoms of post-traumatic stress disorder at 30 and 180 days after hospital discharge. We will also assess for symptoms of depression and anxiety, and health-related quality of life. A generalized linear model, adjusted for time and cluster interactions, will be used to compare AWP in control versus intervention phases, analyzed by intention-to-treat.
DISCUSSION: The ED-AWARENESS-2 Trial will be the first ED-based trial aimed at preventing AWP, a critical threat to patient safety. Results could shape clinical use of NMB in the ED and prevent more than 10,000 annual cases of AWP related to ED care.
TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT05534243 . Registered 06, September 2022
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Operation CoVER Saint Louis (COVID-19 Vaccine in the Emergency Room): Impact of a Vaccination Program in the Emergency Department
Introduction: Coronavirus 2019 (COVID-19) inequitably impacted minority populations and regions with limited access to healthcare resources. The Barnes-Jewish Emergency Department in St. Louis, MO, serves such a population. The COVID-19 vaccine is an available defense to help achieve community immunity. The emergency department (ED) is a potential societal resource to provide access to a vaccination intervention. Our objective in this study was to describe and evaluate a novel ED COVID-19 vaccine program, including its impact on the local surrounding underserved community.
Methods: This was a retrospective, post-protocol implementation review of an ED COVID-19 vaccination program. Over the initial six-month period, we compiled data on all vaccinated patients out of the ED to evaluate demographic data and the impact on underserved regional areas.
Results: We report a successful ED-based COVID-19 vaccine program (with over 1,000 vaccines administered). This program helped raise regional and state vaccination rates. Over 50% of the population that received the COVID-19 vaccine from the ED were from defined socially vulnerable patient populations. No adverse effects were documented.
Conclusion: Operation CoVER (COVID-19 Vaccine in the Emergency Room) Saint Louis was able to successfully vaccinate a socially vulnerable patient population. This free, COVID-19 ED-based vaccine program with dedicated pharmacy support, was novel in emergency medicine practice. Similar ED-based vaccine programs could help with future vaccine distribution
Additional file 4 of Awareness with paralysis and symptoms of post-traumatic stress disorder among mechanically ventilated emergency department survivors (ED-AWARENESS-2 Trial): study protocol for a pragmatic, multicenter, stepped wedge cluster randomized trial
Additional file 4. World Health Organization Trial Registration Data Set items
Additional file 1 of Awareness with paralysis and symptoms of post-traumatic stress disorder among mechanically ventilated emergency department survivors (ED-AWARENESS-2 Trial): study protocol for a pragmatic, multicenter, stepped wedge cluster randomized trial
Additional file 1
Additional file 2 of Awareness with paralysis and symptoms of post-traumatic stress disorder among mechanically ventilated emergency department survivors (ED-AWARENESS-2 Trial): study protocol for a pragmatic, multicenter, stepped wedge cluster randomized trial
Additional file 2. Awareness with Paralysis (AWP) Questionnaire
Additional file 3 of Awareness with paralysis and symptoms of post-traumatic stress disorder among mechanically ventilated emergency department survivors (ED-AWARENESS-2 Trial): study protocol for a pragmatic, multicenter, stepped wedge cluster randomized trial
Additional file 3. SPIRIT Checklist for Trials