Department of Clinical Research, University of Southern Denmark, Odense, Denmark
Department of Emergency Medicine, Slagelse Hospital, Slagelse, Denmark.
BMJ Open. 2020 Jun 3;10(6):e034373. doi: 10.1136/bmjopen-2019-034373.
Among patients admitted to an emergency department, dyspnoea is one of the most common symptoms. Patients with dyspnoea have high mortality and morbidity. Therefore, novel methods to monitor the patients are warranted. The aim is to investigate whether therapy guided by monitoring patients with acute dyspnoea with serial ultrasound examinations of the heart and the lungs together with standard care can change the severity of dyspnoea compared with treatment guided by standard monitoring alone.
The study will be conducted as a multicentre, randomised, pragmatic, open-label and controlled trial where patients admitted with acute dyspnoea to an emergency ward will be randomised into a standard care group and a serial ultrasound group with 103 patients in each. All patients will be examined with an ultrasound of the heart and the lungs upfront. In addition, the patients in the serial ultrasound group will be examined with an ultrasound of the heart and lungs two more times to guide further therapy during the admittance. The primary outcome is a change in dyspnoea on a verbal scale. After discharge, the patients are followed for 1 year to assess the number of readmissions, death and length of hospital stay.
The trial is conducted in accordance with the Declaration of Helsinki and approved by The Regional Committee on Health Research Ethics for Region Zealand, Denmark (identifier SJ-744). Data handling agreement with participating centres has been made (identifier REG-056-2019). The General Data Protection Regulation and the Danish Data Protection Act will be respected. The results of the trial will be reported in peer-reviewed scientific journals regardless of the outcomes.
NCT04091334.
在急诊科收治的患者中，呼吸困难是最常见的症状之一。呼吸困难的患者死亡率和发病率都很高。因此，有必要寻找新的方法来监测这些患者。本研究旨在探讨与仅接受标准监测相比，通过连续超声检查心脏和肺部来监测急性呼吸困难患者的治疗是否能改变呼吸困难的严重程度。
本研究将采用多中心、随机、实用、开放标签和对照试验设计，将因急性呼吸困难收入急诊病房的患者随机分为标准治疗组和连续超声组，每组 103 例。所有患者将接受心脏和肺部超声检查。此外，连续超声组的患者将在住院期间接受两次心脏和肺部超声检查，以指导进一步的治疗。主要结局是采用言语量表评估呼吸困难的变化。出院后，对患者进行为期 1 年的随访，评估再入院次数、死亡和住院时间。
该试验符合《赫尔辛基宣言》的规定，并得到丹麦西兰地区卫生研究伦理委员会（标识符 SJ-744）的批准。与参与中心达成了数据处理协议（标识符 REG-056-2019）。将遵守《通用数据保护条例》和《丹麦数据保护法》。无论结果如何，试验结果都将在同行评审的科学期刊上报告。
NCT04091334。
