BRIPPED Scan for Evaluation of Emergency Department (ED) Patients With Shortness of Breath (BRIPPED)
13. august 2013 oppdatert av: Eastern Virginia Medical School
BRIPPED Scan for Evaluation of Emergency Department 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.
Studieoversikt
Status
Fullført
Forhold
Detaljert beskrivelse
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.
Studietype
Observasjonsmessig
Registrering (Faktiske)
104
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Virginia
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Norfolk, Virginia, Forente stater, 23507
- Sentara Norfolk General Emergency Department
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 89 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
A convenience sample of community subjects presenting to an Academic Hospital Emergency Department (volume approx 60,000 patients per year).
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
|---|
|
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
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
magnitude of change of differential diagnosis of the treating physician
Tidsramme: duration of ED course, which is expected to be an average of 3 hours
|
duration of ED course, which is expected to be an average of 3 hours
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
time to complete the exam
Tidsramme: 3 to 30 minutes during the ED course
|
3 to 30 minutes during the ED course
|
|
|
time to disposition in control group compared to group receiving the BRIPPED scan
Tidsramme: duration of ED course, which is expected to be an average of 3 hours, with a range of 45 minutes to 6 hours
|
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
Tidsramme: duration of the ED course, which is expected to be an average of 3 hours, with a range of 45 minutes to 6 hours
|
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
Tidsramme: 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
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30 days after presentation to ED
|
Samarbeidspartnere og etterforskere
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Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Virginia M Stewart, MD, Eastern Virginia Medical School
Publikasjoner og nyttige lenker
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Studierekorddatoer
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Studer hoveddatoer
Studiestart
1. oktober 2011
Primær fullføring (Faktiske)
1. mai 2012
Studiet fullført (Faktiske)
1. mai 2012
Datoer for studieregistrering
Først innsendt
16. februar 2012
Først innsendt som oppfylte QC-kriteriene
9. august 2012
Først lagt ut (Anslag)
10. august 2012
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
14. august 2013
Siste oppdatering sendt inn som oppfylte QC-kriteriene
13. august 2013
Sist bekreftet
1. august 2013
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 11-07-FB-0204-HOSP
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