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

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: BRIPPED Scan for Evaluation of Emergency Department Patients With Shortness of Breath

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 Summary: 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.
Sponsor: Eastern Virginia Medical School

Current 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 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]
    Electronic medical record review of patients who present with shortness of breath 30 days after initial presentation, evaluation and treatment


Original Secondary Outcome: Same as current

Information By: Eastern Virginia Medical School

Dates:
Date Received: February 16, 2012
Date Started: October 2011
Date Completion:
Last Updated: August 13, 2013
Last Verified: August 2013