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

This study has been completed.
Sponsor:
Collaborator:
Emergency Medicine Foundation
Information provided by (Responsible Party):
Eastern Virginia Medical School
ClinicalTrials.gov Identifier:
NCT01662843
First received: February 16, 2012
Last updated: August 13, 2013
Last verified: August 2013
  Purpose

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.


Condition
Dyspnea

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: BRIPPED Scan for Evaluation of Emergency Department Patients With Shortness of Breath

Resource links provided by NLM:


Further study details as provided by Eastern Virginia Medical School:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • time to complete the exam [ Time Frame: 3 to 30 minutes during the ED course ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Recidivism rates among both cohorts, or evaluation of return to the ED within 30 days [ Time Frame: 30 days after presentation to ED ] [ Designated as safety issue: No ]
    Electronic medical record review of patients who present with shortness of breath 30 days after initial presentation, evaluation and treatment


Enrollment: 104
Study Start Date: October 2011
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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

Ages Eligible for Study:   18 Years to 89 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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).

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01662843

Locations
United States, Virginia
Sentara Norfolk General Emergency Department
Norfolk, Virginia, United States, 23507
Sponsors and Collaborators
Eastern Virginia Medical School
Emergency Medicine Foundation
Investigators
Principal Investigator: Virginia M Stewart, MD Eastern Virginia Medical School
  More Information

No publications provided

Responsible Party: Eastern Virginia Medical School
ClinicalTrials.gov Identifier: NCT01662843     History of Changes
Other Study ID Numbers: 11-07-FB-0204-HOSP
Study First Received: February 16, 2012
Last Updated: August 13, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Eastern Virginia Medical School:
Dyspnea
Ultrasonography
Emergencies
Critical Care

Additional relevant MeSH terms:
Dyspnea
Emergencies
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014