Ultrasonography in the Emergency Department. A Randomised Controlled Multicenter Study.
试验速览
- 阶段
- 不适用
- 入组人数
- 288
- 主要终点
- The percentage of correctly diagnosed patients 4 hours after arrival in the emergency department.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
The percentage of correctly diagnosed patients 4 hours after arrival in the emergency department.
时间窗: 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.
次要结局
未报告次要终点
研究者
Minna Riishede
Ph.d.-student, MD
Odense University Hospital