BRIPPED Scan for Evaluation of Emergency Department Patients With Shortness of Breath
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- magnitude of change of differential diagnosis of the treating physician
研究概览
简要总结
The B-RIPPED scan is a standardized ultrasound evaluation of pulmonary B-lines, Right ventricle size and strain, Inferior Vena Cava collapsibility, Pleural and Pericardial Effusion, Pneumothorax, Ejection Fraction, and lower extremity Deep Venous Thrombosis. Primary outcomes measured are the magnitude of change in differential diagnoses.
详细描述
This prospective randomized control trial will be performed on a convenience sample of 200 patients presenting with undifferentiated SOB to an academic emergency department (ED) (volume 56,000 patients/year). Subjects are excluded if they have a known history of asthma, are 20 or more weeks pregnant, or have had thoraco-abdominal trauma in the past 72 hours. The BRIPPED pilot investigation (IRB #10-02-FB-0026) enrolled 43 patients and physician subjects from 4/30/2010 to 1/20/2011. This study differs in methodology from the pilot study in the reduction of the total number of ultrasound images obtained to decrease the total time to perform the scan. Instead of a cohort study, this randomized control trial includes the addition of a control group for cost and time saved comparison. As in the pilot study, eligible patients will be evaluated by the treating ED physician who will rank potential diagnoses from most to least likely. A study investigator performs the B-RIPPED scan and provides the initial treating physician with the results. The treating physician will again be asked to complete a differential diagnosis ranking knowing the B-RIPPED results. Changes in the differential diagnosis ranking, physician orders, and interventions will be compiled. A randomized control cohort will be assigned for eligible patients. In the control group, the treating physician will complete the diagnosis rank list prior to the completion of the workup, and then once all lab values are back. Time to disposition, and comparison of labs and radiology tests ordered will be compared to the cohort receiving the BRIPPED scan. Patients will be assigned a number at time of enrollment, which randomly assigns them to the control or experimental (patients receiving the BRIPPED scan) group. Packets containing the appropriate data collection form (control or experimental) will be organized so even numbered patients will belong to one group, and odd numbered patients will be assigned to the other.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects are included if they are between the ages of 18-89 and present to the Emergency Department with a chief complaint of shortness of breath or dyspnea.
排除标准
- •known history of asthma,
- •are 20 or more weeks pregnant, or
- •have had thoraco-abdominal trauma in the past 72 hours.
结局指标
主要结局
magnitude of change of differential diagnosis of the treating physician
时间窗: duration of ED course, which is expected to be an average of 3 hours
次要结局
- time to complete the exam(3 to 30 minutes during the ED course)
- time to disposition in control group compared to group receiving the BRIPPED scan(duration of ED course, which is expected to be an average of 3 hours, with a range of 45 minutes to 6 hours)
- labs, consults, medications and other orders added or discontinued after the treating physician is informed of the BRIPPED scan results(duration of the ED course, which is expected to be an average of 3 hours, with a range of 45 minutes to 6 hours)
- Recidivism rates among both cohorts, or evaluation of return to the ED within 30 days(30 days after presentation to ED)