Focused Sonographic Examination of the Heart, Lungs and Deep Veins in an Unselected Population of Acute Admitted Patients With Respiratory Symptoms: a Randomised Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 315
- 试验地点
- 1
- 主要终点
- The number of patients with a correct presumptive diagnosis within 4 hours after hospital admission.
研究概览
简要总结
The purpose of this study is to determine whether focused sonography of the heart, lungs and deep veins can increase the number of patients with respiratory symptoms correctly diagnosed in an emergency department.
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 (Outcomes Assessor)
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 of the following must be present:
- •The sonographic examination can be performed before or within 1 hour after the primary evaluation
- •Patient is 18 years or older
- •Patient able and willing to give informed consent
- •One ore more of the following symptoms or clinical findings at admission to the emergency department
- •Respiratory rate > 20 breaths per minute
- •Saturation < 95%
- •Oxygen therapy initiated
- •The patient has a principal complaint of dyspnoea
- •The patient has a principal complaint of coughing
- •The patient has a principal complaint of chest pain
排除标准
- •One of the following:
- •The sonographic examination can not be performed within 1 hour after the primary evaluation
- •The patient is 17 years or younger
- •The patient not able or willing to give informed consent
研究组 & 干预措施
Focused sonography
Intervention group: After the primary evaluation by a physician in the emergency department, focused sonography of the patients heart, lungs and deep veins in the legs are performed. Hereafter the further examinations and treatment are done according to hospital guidelines.
干预措施: Focused Sonography of the heart, lungs and deep veins (Other)
Usual treatment and diagnostic work-up
Control group: After the primary evaluation by a physician in the emergency department. Hereafter the further examinations and treatment are done according to hospital guidelines.
结局指标
主要结局
The number of patients with a correct presumptive diagnosis within 4 hours after hospital admission.
时间窗: 4 hours after hospital admission
The 4-hour presumptive diagnosis are compared to the final diagnosis obtained by audit after the patient has been discharged from the hospital (gold standard).
次要结局
- Number of patients transferred to an intensive care unit(Participants will be followed for the duration of the hospital stay, an expected range of up to 5 weeks)
- Number of patients given an appropriate, inappropriate and no specific treatment after primary evaluation in the control group and after sonography in the intervention group(Participants will be followed for the duration of the hospital stay, an expected range of up to 5 weeks)
- Number of patients with a correct presumptive diagnosis after primary evaluation in the control group and after sonography in the intervention group.(Participants will be followed for the duration of the hospital stay, an expected range of up to 5 weeks)
- Sensitivity, specificity, positive predictive values, negative predictive values and diagnostic accuracy of the primary evaluation and the "4-hour" presumptive diagnosis.(Participants will be followed for the duration of the hospital stay, an expected range of up to 5 weeks)
- Number of patients receiving appropriate, inappropriate and no specific treatment 4-hours after admission(Participants will be followed for the duration of the hospital stay, an expected range of up to 5 weeks)
- 30 day mortality(30 days after the patient has been admitted to the hospital)
- In-hospital mortality(Participants will be followed for the duration of the hospital stay, an expected range of up to 5 weeks)
- Time to diagnostic / therapeutic thoracocentesis(Participants will be followed for the duration of the hospital stay, an expected range of up to 5 weeks)
- Length of hospital stay(Participants will be followed for the duration of the hospital stay, an expected range of up to 5 weeks)
研究者
Christian Borbjerg Laursen
Principal Investigator
Odense University Hospital