Ultrasonography in the Emergency Department. A Randomised Controlled Multicenter Study.
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Odense University Hospital
- Enrollment
- 288
- Primary Endpoint
- The percentage of correctly diagnosed patients 4 hours after arrival in the emergency department.
Study Overview
Brief Summary
Aim To investigate if the proportion of correctly diagnosed patients at 4 hours after arrival to the Emergency Department (ED) increases when patients are diagnosed with standard diagnostics and focused ultrasonography examination (f-US) compared to standard diagnostics alone.
Methods The investigators are medical doctors who work in the ED and who use f-US as a diagnostic tool. The patients are those arriving to the ED with symptoms of difficulties of respiration.
All patients receive a f-US but only in the intervention group these results will be unblinded to the treating physician once he has made his 1. presumptive diagnosis . A final presumptive diagnosis has to be made within 4 hours from the patient´s admittance to the ED.
The correct diagnosis is assessed by a blinded audit of the medical journal. This project holds the potential to develop evidence-based optimization of early diagnostic accuracy.
Detailed Description
Protocol RCT 1.4 Ultrasonography in the Emergency Department A Randomised Controlled Multicenter Study RCT 1.4.1
Background Patients arriving to the Emergency Department with acute symptoms of respiratory problems are a diagnostic challenge. Their symptoms can be very similar and at times life threatening but require different specific treatments. The assessment of a fast and correct diagnosis is therefore of high importance in these patients where a correct and instant treatment can be lifesaving.
In 2014 Lancet Respiratory Medicine published an article written by Laursen et al. They presented at Danish study that showed that by using a focused ultrasonographic examination as a complementary tool to the regular diagnostic assessment of patients with respiratory symptoms they increased not only the percentage of patients receiving a correct diagnosis but also the percentage of patients receiving correct treatment within 4 hours after admittance to the Emergency Department.
The study was criticized for being performed by a single physician, who is a very experienced ultrasonographer at a single center and therefore not transferrable to the Danish Emergency Departments and their physicians in general.
Consequently this study is an expansion of the study of Laursen et al. accommodating some of the points of criticism. It will be executed as a multicenter study in several Danish Emergency Departments. The ultrasonographic examination will be performed and interpreted by the medical physicians who already work at the emergency departments.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- Single (Care Provider)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •All 4 parts have to be fulfilled.
- •The patient is 18 years or more.
- •The patient has arrived acutely to FAM.
- •The patient presents with one or more of the following symptoms:
- •Chest pain
- •Respiration frequency > 20
- •Peripheral saturation < 95%
- •Written informed consent from habile patient.
Exclusion Criteria
- •The patient is not capable of giving informed consent. .
- •The US of the lungs or the heart has already been performed by others than the investigator in relation to the primary assessment.
- •The Randomization and US cannot be performed within 4 hours from the patients admittance to the ED.
Arms & Interventions
Ultrasonography findings unblinded
Intervention group: Patients in this group will receive a focused ultrasonography examination of the heart and the lungs which will be performed by the investigator.
Intervention: The treating physician receives the results from the ultrasonographic examination (=unblinding of ultrasonography examination results).
Intervention: Focused ultrasonographic examination. (Other)
Ultrasonography findings blinded
Control group: Patients in this group will receive a focused ultrasonography examination of the heart and the lungs which will be performed by the investigator.
Active Comparator: The ultrasonographic examination results will remain blinded for the treating physician.
Intervention: Focused ultrasonographic examination. (Other)
Outcomes
Primary Outcomes
The percentage of correctly diagnosed patients 4 hours after arrival in the emergency department.
Time Frame: Measured at 4 hours after the patient has arrived to the Emergency Department
To measure and compare the percentage of correctly diagnosed patients at the time point '4 hours after admittance to the ED´ in between the intervention group and the control group.
Secondary Outcomes
No secondary outcomes reported
Investigators
Minna Riishede
Ph.d.-student, MD
Odense University Hospital