Clinical trial NCT01662843: BRIPPED Scan for Evaluation of Emergency Department (ED) Patients With Shortness of Breath
Official title: BRIPPED Scan for Evaluation of Emergency Department Patients With Shortness of Breath
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dyspnea
Keywords: Dyspnea
Ultrasonography
Emergencies
Critical Care
Lead sponsor: Eastern Virginia Medical School
Sponsor class: OTHER
Collaborators: name: Emergency Medicine Foundation
First posted: 2012-08-10
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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).

Brief 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. 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.

Eligibility criteria: 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.

Primary outcomes:
measure: magnitude of change of differential diagnosis of the treating physician
timeFrame: duration of ED course, which is expected to be an average of 3 hours
Secondary outcomes:
measure: time to complete the exam
timeFrame: 3 to 30 minutes during the ED course
measure: time to disposition in control group compared to group receiving the BRIPPED scan
timeFrame: duration of ED course, which is expected to be an average of 3 hours, with a range of 45 minutes to 6 hours
measure: labs, consults, medications and other orders added or discontinued after the treating physician is informed of the BRIPPED scan results
timeFrame: duration of the ED course, which is expected to be an average of 3 hours, with a range of 45 minutes to 6 hours
measure: Recidivism rates among both cohorts, or evaluation of return to the ED within 30 days
timeFrame: 30 days after presentation to ED
Other outcomes:
Locations:
city: Norfolk
country: United States
facility: Sentara Norfolk General Emergency Department
state: Virginia
Study officials:
affiliation: Eastern Virginia Medical School
name: Virginia M Stewart, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.