Effect of a Point-of-Care Ultrasound-Driven vs Standard Diagnostic Pathway on 24-Hour Hospital Stay in Emergency Department Patients with Dyspnea—Protocol for A Randomized Controlled Trial

Stig Holm Ovesen,1,2 Søren Helbo Skaarup,3 Rasmus Aagaard,4 Hans Kirkegaard,1 Bo Løfgren,1,5 Michael Dan Arvig,6– 8 Bo Martin Bibby,9 Stefan Posth,10 Christian B Laursen,11,12 Jesper Weile1,2 1Research Center for Emergency Medicine, Department of Clinical Medicine, Aarhus University Hospital and Aarhus University, Aarhus, Denmark; 2Emergency Department, Horsens Regional Hospital, Horsens, Denmark; 3Department of Respiratory Diseases and Allergy, Aarhus University Hospital, Aarhus, Denmark; 4Department of Anesthesiology, Aarhus University Hospital, Aarhus, Denmark; 5Department of Internal Medicine, Randers Regional Hospital, Randers, Denmark; 6Emergency Department, Slagelse Hospital, Slagelse, Denmark; 7Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark; 8Department of Regional Health Research, University of Southern Denmark, Odense, Denmark; 9Department of Biostatistics, Aarhus University, Aarhus, Denmark; 10Emergency Department, Odense University Hospital, Odense, Denmark; 11Department of Respiratory Medicine, Odense University Hospital, Odense, Denmark; 12Odense Respiratory Research Unit (ODIN), Department of Clinical Research, University of Southern Denmark, Odense, DenmarkCorrespondence: Stig Holm Ovesen, Research Center for Emergency Medicine, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, J103, Aarhus, 8200, Denmark, Email stigholm@clin.au.dkPurpose: Point-of-care ultrasound (POCUS) helps emergency department (ED) physicians make prompt and appropriate decisions, but the optimal diagnostic integration and potential clinical benefits remain unclear. We describe the protocol and statistical analysis plan for a randomized controlled trial. The objective is to determine the effect of a POCUS-driven diagnostic pathway in adult dyspneic ED patients on the proportion of patients having a hospital stay of less than 24 hours when compared to the standard diagnostic pathway.Patients and Methods: This is a multicenter, randomized, investigator-initiated, open-labeled, pragmatic, controlled trial. Adult ED patients with chief complaint dyspnea are eligible. Patients are randomized (1:1) to the POCUS-driven diagnostic pathway or standard diagnostic pathway, with 337 patients in each group. The primary outcome is the proportion of patients having a hospital stay (from ED arrival to hospital discharge) of less than 24 hours. Key secondary outcomes include hospital length-of-stay, 72-hour revisits, and 30-day hospital-free days.Conclusion: Sparse evidence exists for any clinical benefit from a POCUS-integrated diagnostic pathway. The results from this trial will help clarify the promising signals for POCUS to influence patient care among ED patients with dyspnea.Keywords: focused lung ultrasound, focused cardiac ultrasound, shortness-of-breath, diagnostic effectiveness