BRIPPED Scan for Evaluation of Emergency Department (ED) Patients With Shortness of Breath (BRIPPED)
2013年8月13日 更新者:Eastern Virginia Medical School
BRIPPED Scan for Evaluation of Emergency Department Patients With Shortness of Breath
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.
研究概览
地位
完全的
条件
详细说明
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.
研究类型
观察性的
注册 (实际的)
104
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
-
Virginia
-
Norfolk、Virginia、美国、23507
- Sentara Norfolk General Emergency Department
-
-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 89年 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
取样方法
非概率样本
研究人群
A convenience sample of community subjects presenting to an Academic Hospital Emergency Department (volume approx 60,000 patients per year).
描述
Inclusion Criteria:
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.
Exclusion Criteria:
- known history of asthma,
- are 20 or more weeks pregnant, or
- have had thoraco-abdominal trauma in the past 72 hours.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
---|
BRIPPED scan
Patients presenting with undifferentiated shortness of breath who receive the ultrasound scan in addition to standard of care
|
Control
Patients who only receive the standard of care for undifferentiated shortness of breath
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
magnitude of change of differential diagnosis of the treating physician
大体时间:duration of ED course, which is expected to be an average of 3 hours
|
duration of ED course, which is expected to be an average of 3 hours
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
time to complete the exam
大体时间:3 to 30 minutes during the ED course
|
3 to 30 minutes during the ED course
|
|
time to disposition in control group compared to group receiving the BRIPPED scan
大体时间:duration of ED course, which is expected to be an average of 3 hours, with a range of 45 minutes to 6 hours
|
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
大体时间:duration of the ED course, which is expected to be an average of 3 hours, with a range of 45 minutes to 6 hours
|
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
大体时间:30 days after presentation to ED
|
Electronic medical record review of patients who present with shortness of breath 30 days after initial presentation, evaluation and treatment
|
30 days after presentation to ED
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Virginia M Stewart, MD、Eastern Virginia Medical School
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2011年10月1日
初级完成 (实际的)
2012年5月1日
研究完成 (实际的)
2012年5月1日
研究注册日期
首次提交
2012年2月16日
首先提交符合 QC 标准的
2012年8月9日
首次发布 (估计)
2012年8月10日
研究记录更新
最后更新发布 (估计)
2013年8月14日
上次提交的符合 QC 标准的更新
2013年8月13日
最后验证
2013年8月1日
更多信息
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