Monitoring Patients With Acute Dyspnea With Serial Focused Ultrasound of the Heart and the Lungs
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 206
- 试验地点
- 2
- 主要终点
- Change in dyspnea severity on a verbal dyspnea scale (VDS) from 0-10
研究概览
简要总结
Purpose of the study: The purpose of the trial is to investigate whether repeated ultrasound scans of the heart and lungs of patients with shortness of breath may help to optimize their treatment. This patient group is characterized by an extended hospitalization and a high mortality rate. Therefore, it is essential to be able to target the treatment in order to shorten length of stay, prevent readmissions, and improve survival in these patients. Ultrasound scanning used in this way is novel.
The study method: Initially, all patients will receive standard evaluation and ultrasound of the heart and the lungs. Then the patients are randomly assigned into two groups. In one group, patients receive standard assessment and treatment. In the second group, the patients, in addition to standard examination and treatment, receive ultrasound scans of their heart and lungs after two hours and again fire hours after the first scan.
After discharge, the subjects are followed for one year to evaluate what examinations and treatment they received during hospitalization, whether they have been readmitted or died.
详细描述
Design: Multicenter, randomized, controlled, open-label, and pragmatic trial.
Settings: Several different emergency departments (EDs) in Denmark.
Study flow: After arrival, the patients are screened according to eligibility criteria. If patients meet the inclusion criteria and informed consent is obtained, the patients are randomly assigned to one of two groups. In both groups, the patients received standard evaluation, e.g., blood samples, physical examination, arterial blood gas, and in addition ultrasound examination of the heart and the lungs. In the intervention group, the patients are further examined with serial ultrasound scans of the heart and the lungs after two and four hours after the initial evaluation.
In the course of admittance, the patients will have there baseline characteristics recorded together with the ultrasound findings, symptoms, and vitals. Symptoms will be recorded at a verbal dyspnea symptom scale (VDS) from 0-10.
All data will be registered at the same time points to make comparisons: At 1, 2, 4 and after 5 hours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Participants should be 18 years or older
- •Presented at the ED with shortness of breath (asking the patient upon arrival in the triage what their primary complaint is for a referral to an emergency department)
- •Written informed consent obtained from the patient
排除标准
- •Patients with dyspnea primary admitted because of a trauma
结局指标
主要结局
Change in dyspnea severity on a verbal dyspnea scale (VDS) from 0-10
时间窗: Assessed within 1 hour from arrival, again after two, four hours and five hours
Self reported severity of dyspnea. 0 = no dyspnea. 10 = worst dyspnea ever.
次要结局
- Number of readmission(s)(Assessed up to 12 months from inclusion of the last patient.)
- All-cause mortality after discharge(Assessed up to 12 months from inclusion of the last patient.)
- Lenght of stay(Assessed after 30 days from inclusion of the last patient.)
- IVC-CI (inferior vena cava collapsibility index) correlated to vital signs and VDS(Assessed within 1 hour from arrival, again after two, four hours and five hours)
- The changes in IVC-CI between the ultrasound examinations(Assessed within 1 hour from arrival, again after two, four hours and five hours)
- The changes in B-line count between the ultrasound examinations(Assessed within 1 hour from arrival, again after two, four hours and five hours)
- In-hospital all-cause mortality(Assessed after 30 days from inclusion of the last patient.)
- B-line count correlated to vital signs and VDS(Assessed within 1 hour from arrival, again after two, four hours and five hours)