Patients admitted to hospital with acute respiratory symptoms remain a diagnostic challenge for the emergency physician. The use of focused sonography may improve the initial diagnostics, as most of the diseases, commonly seen and misdiagnosed in patients with acute respiratory symptoms, can be diagnosed with sonography. The protocol describes a prospective, blinded, randomised controlled trial that aims to assess the diagnostic impact of a pragmatic implementation of focused sonography of the heart, lungs and deep veins as a diagnostic modality in acute admitted patients with respiratory symptoms.
Methods and analysis
The primary outcome of the study is the number of patients with a correct presumptive diagnosis within 4 h of admission to the emergency department. The patient is randomised to either an intervention or a control group. In the intervention group, the usual initial diagnostic work up is supplemented by focused sonographic examination of the heart, lungs and deep veins of the legs. In the control group, usual diagnostic work up is performed. The χ2 test, alternatively the Fischer exact test will be used, to establish whether there is a difference in the distribution of the total number of patients with a correct/incorrect ‘4 h’ presumptive diagnosis in the control group and in the intervention group.
Ethics and dissemination
This clinical trial is performed according to the Declaration of Helsinki and has been approved by the Regional Scientific Ethical Committee for Southern Denmark and the Danish Data Protection Agency. The results of the trial will be published according to the CONSORT statement with the extension for pragmatic trials. The results of the trial will be published in a peer-reviewed scientific journal regardless of the outcome.
Trial registration number
This study is registered at http://clinicaltrials.gov, registration number NCT01486394.
Focused sonography of the heart, lungs and deep veins.
Initial diagnostics of acute admitted patients with respiratory symptoms.
The results of the study may help to determine whether sonography should be included as a fully integrated part of the primary evaluation in these patients.
Strengths and limitations of this study
First randomised trial to compare the overall diagnostic performance between the conventional approach and an approach including focused sonography to evaluate and diagnose acute admitted patients with respiratory symptoms, admitted to an emergency department.
Pragmatic design with inclusion of most patients with respiratory symptoms.
Single-centre study that could affect external validity.
Study not powered to investigate morbidity or mortality.