Ovesen Stig Holm, Skaarup Søren Helbo, Aagaard Rasmus, Kirkegaard Hans, Løfgren Bo, Arvig Michael Dan, Bibby Bo Martin, Posth Stefan, Laursen Christian B, Weile Jesper
Research Center for Emergency Medicine, Department of Clinical Medicine, Aarhus University Hospital and Aarhus University, Aarhus, Denmark.
Emergency Department, Horsens Regional Hospital, Horsens, Denmark.
Open Access Emerg Med. 2024 Aug 27;16:211-219. doi: 10.2147/OAEM.S454062. eCollection 2024.
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.
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.
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.
床旁超声(POCUS)有助于急诊科(ED)医生迅速做出恰当决策,但最佳诊断整合及潜在临床获益仍不明确。我们描述了一项随机对照试验的方案和统计分析计划。目的是确定与标准诊断途径相比,POCUS驱动的诊断途径对成年急诊呼吸困难患者住院时间少于24小时的患者比例的影响。
这是一项多中心、随机、研究者发起、开放标签、务实的对照试验。以呼吸困难为主诉的成年急诊患者符合条件。患者被随机(1:1)分配至POCUS驱动的诊断途径或标准诊断途径,每组337例患者。主要结局是住院时间(从到达急诊科至出院)少于24小时的患者比例。关键次要结局包括住院时长、72小时复诊率和30天无住院天数。
关于POCUS整合诊断途径的任何临床获益的证据都很少。该试验结果将有助于阐明POCUS在影响急诊呼吸困难患者护理方面的有前景的信号。