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

Dyspnea Clinical Trial

— BRIPPED  

Official title:

BRIPPED Scan for Evaluation of Emergency Department Patients With Shortness of Breath

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01662843
• Other study ID #: 11-07-FB-0204-HOSP
• Status: Completed
• Phase: N/A
• First received: February 16, 2012
• Last updated: August 13, 2013
• Start date: October 2011
• Est. completion date: May 2012

Study information

• Verified date: August 2013
• Source: Eastern Virginia Medical School
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical 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. Primary outcomes measured are the magnitude of change in differential diagnoses.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 89 Years

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Dyspnea
• Emergencies

Locations

Country	Name	City	State
United States	Sentara Norfolk General Emergency Department	Norfolk	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Eastern Virginia Medical School	Emergency Medicine Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	magnitude of change of differential diagnosis of the treating physician		duration of ED course, which is expected to be an average of 3 hours	No
Secondary	time to complete the exam		3 to 30 minutes during the ED course	No
Secondary	time to disposition in control group compared to group receiving the BRIPPED scan		duration of ED course, which is expected to be an average of 3 hours, with a range of 45 minutes to 6 hours	No
Secondary	labs, consults, medications and other orders added or discontinued after the treating physician is informed of the BRIPPED scan results		duration of the ED course, which is expected to be an average of 3 hours, with a range of 45 minutes to 6 hours	No
Secondary	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	30 days after presentation to ED	No