Focused ultrasound examination of the chest on patients admitted with acute signs of respiratory problems: a study protocol for a pragmatic randomised controlled multicentre trial

INTRODUCTION: Patients with acute respiratory problems poses a diagnostic challenge because similar symptoms can be caused by various pathological conditions. Focused ultrasound examination (f-US) of the heart and lungs has proven to increase the diagnostic accuracy in these patients. In this protocol of a randomised multicentre trial, we study the effect of f-US of the heart and lungs in patients with respiratory problems performed by emergency physicians (EP) as soon as the patient arrives to the emergency department (ED). The primary outcome is the number of patients with a correct presumptive diagnosis at 4 hours from admission. METHODS AND ANALYSIS: This is a semiblinded randomised prospective study. 288 patients will be included and randomised into the control or intervention group. All patients receive a standard diagnostic evaluation by the EP to assess the primary presumptive diagnosis. Investigators are EP, with varying degrees of experience in f-US, who perform an f-US of the heart and lungs in patients in both treatment arms. f-US results in the intervention group are non-blinded to the treating EP to be included in the assessment of the 4-hour presumptive diagnosis. As standard for correct diagnosis, we perform a blinded journal audit after discharge. As primary analysis, we use the intention-to-treat analysis. CONCLUSIONS: This study is the first multicentre trial in EDs to investigate whether f-US, in the hands of the EP, increases the proportion of correct diagnosis at 4 hours after arrival when performed on patients with respiratory problems. ETHICS AND DISSEMINATION: This trial is conducted in accordance with the Helsinki II Declaration and approved by the Danish Data Protection Agency and the Committee on Biomedical Research Ethics for the Region of Southern Denmark. Results will be published in accordance with the CONSORT statement in a peer-reviewed scientific journal regardless of the outcome. TRIAL REGISTRATION NUMBER: NCT02550184; Pre-results.