BRIPPED Scan for Evaluation of Emergency Department (ED) Patients With Shortness of Breath

NCT ID: NCT01662843

Last Updated: 2013-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

104 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-10-31

Study Completion Date

2012-05-31

Brief Summary

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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

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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

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Dyspnea

Keywords

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Dyspnea Ultrasonography Emergencies Critical Care

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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BRIPPED scan

Patients presenting with undifferentiated shortness of breath who receive the ultrasound scan in addition to standard of care

No interventions assigned to this group

Control

Patients who only receive the standard of care for undifferentiated shortness of breath

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Emergency Medicine Foundation

OTHER

Sponsor Role collaborator

Eastern Virginia Medical School

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Virginia M Stewart, MD

Role: PRINCIPAL_INVESTIGATOR

Eastern Virginia Medical School

Locations

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Sentara Norfolk General Emergency Department

Norfolk, Virginia, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 26704772 (View on PubMed)

Other Identifiers

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11-07-FB-0204-HOSP

Identifier Type: -

Identifier Source: org_study_id