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Completed

NCT Number: NCT01662843

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

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.

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Key information

Conditions

Dyspnea Disease Attributes Emergencies Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sentara Norfolk General Emergency Department

Norfolk, Virginia, 23507, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. time to complete the exam

    Time frame: 3 to 30 minutes during the ED course

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Eastern Virginia Medical School

Other

Collaborators

  • Emergency Medicine Foundation

Registry information

Official study title

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

Acronym: BRIPPED

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Aug 10, 2012
Registry last updated
Aug 14, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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