DyspneaBRIPPEDNCT01662843
BRIPPED Scan for Evaluation of Emergency Department (ED) Patients With Shortness of Breath
An observational study of Dyspnea, run by Eastern Virginia Medical School at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Dyspnea
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to May 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: A convenience sample of community subjects presenting to an Academic Hospital Emergency Department (volume approx 60,000 patients per year).
Who may be able to join
- 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.
Who cannot join
- known history of asthma,
- are 20 or more weeks pregnant, or
- have had thoraco-abdominal trauma in the past 72 hours.
Trial locations and contacts
1 site in 1 country.
United States1 site
Sentara Norfolk General Emergency Department
Norfolk, Virginia, 23507
About this study
Official title: 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.
Read the 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.
- Conditions
- Dyspnea
- Keywords
- Dyspnea, Ultrasonography, Emergencies, Critical Care
- Medical subject headings
- Dyspnea, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
magnitude of change of differential diagnosis of the treating physician
Measured: duration of ED course, which is expected to be an average of 3 hours
Secondary outcomes (4)
time to complete the exam
Measured: 3 to 30 minutes during the ED course
time to disposition in control group compared to group receiving the BRIPPED scan
Measured: 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
Measured: 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
Electronic medical record review of patients who present with shortness of breath 30 days after initial presentation, evaluation and treatment
Measured: 30 days after presentation to ED
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2012 (estimated)
- Study startOct 2011
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DyspneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eastern Virginia Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- Emergency Medicine Foundation
- Responsible party
- Sponsor
- Investigators
- Virginia M Stewart, MD, Principal investigator, Eastern Virginia Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01662843
- Sponsor's protocol ID
- 11-07-FB-0204-HOSP
- Acronym
- BRIPPED
- Status last verified
- Aug 2013
- First submitted
- 16 Feb 2012
- Last updated
- 14 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Stewart VM, Bjornsson HM, Clinton M, Byars DV. BRIPPED scan for evaluation of ED patients with shortness of breath. Am J Emerg Med. 2016 Mar;34(3):386-91. doi: 10.1016/j.ajem.2015.11.006. Epub 2015 Nov 5.
PubMed 26704772
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BRIPPED Scan for Evaluation of Emergency Department Patients With Shortness of Breath
- ClinicalTrials.gov ID
- NCT01662843
- Acronym / sponsor ID
- BRIPPED / 11-07-FB-0204-HOSP
- Conditions
- Dyspnea
- Keywords
- Dyspnea, Ultrasonography, Emergencies, Critical Care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Eastern Virginia Medical SchoolUniversity, hospital or other
- Collaborators
- Emergency Medicine Foundation
- Study start
- Oct 2011
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 10 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A convenience sample of community subjects presenting to an Academic Hospital Emergency Department (volume approx 60,000 patients per year).
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- known history of asthma,
- are 20 or more weeks pregnant, or
- have had thoraco-abdominal trauma in the past 72 hours.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
4 secondary outcomes
time to complete the exam
Time frame: 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
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
Recidivism rates among both cohorts, or evaluation of return to the ED within 30 days
Time frame: 30 days after presentation to ED
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2013.
- Derived from this study: PubMed 26704772Stewart VM, Bjornsson HM, Clinton M, Byars DV. BRIPPED scan for evaluation of ED patients with shortness of breath. Am J Emerg Med. 2016 Mar;34(3):386-91. doi: 10.1016/j.ajem.2015.11.006. Epub 2015 Nov 5.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Virginia M Stewart, MD principal investigator
Eastern Virginia Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dyspnea, run by Eastern Virginia Medical School at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01662843, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2013; AzTrials last refreshed its copy on 8 Nov 2026.