- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01662843
BRIPPED Scan for Evaluation of Emergency Department (ED) Patients With Shortness of Breath (BRIPPED)
August 13, 2013 updated by: 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.
Study Overview
Status
Completed
Conditions
Detailed Description
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.
Study Type
Observational
Enrollment (Actual)
104
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Virginia
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Norfolk, Virginia, United States, 23507
- Sentara Norfolk General Emergency Department
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 89 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
A convenience sample of community subjects presenting to an Academic Hospital Emergency Department (volume approx 60,000 patients per year).
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
magnitude of change of differential diagnosis of the treating physician
Time Frame: 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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
time to complete the exam
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Virginia M Stewart, MD, Eastern Virginia Medical School
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2011
Primary Completion (Actual)
May 1, 2012
Study Completion (Actual)
May 1, 2012
Study Registration Dates
First Submitted
February 16, 2012
First Submitted That Met QC Criteria
August 9, 2012
First Posted (Estimate)
August 10, 2012
Study Record Updates
Last Update Posted (Estimate)
August 14, 2013
Last Update Submitted That Met QC Criteria
August 13, 2013
Last Verified
August 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 11-07-FB-0204-HOSP
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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