- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02719509
Emergency Department Cardiac Ultrasound
Prospective Evaluation of the Utility of Bedside Cardiac Ultrasound for Undifferentiated Chest Pain and Shortness of Breath in the Emergency Department
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Bedside cardiac ultrasound is performed regularly in the emergency department to assess patients who present with undifferentiated chest pain or shortness of breath. Utility of cardiac ultrasound in this setting is emerging as standard of care. Cardiac ultrasound can rapidly provide essential information about the presence or absence of multiple cardiopulmonary pathologies. Cardiac ultrasound is safe, immediately accessible, and gives providers data regarding their patients in real-time.
While cardiac ultrasound is common practice in emergency departments, the diagnostic utility of this test has been difficult to study. There are few studies in the literature that describe its utility in evaluating specific diagnoses. These studies have evaluated the use of cardiac ultrasound in diagnosing acute cardiogenic pulmonary edema, aortic dilation/aneurysm, acute coronary syndrome, and acute heart failure.
The purpose of this study is to evaluate the utility of cardiac ultrasound in patients who present to the emergency department with undifferentiated chest pain or shortness of breath. This study will evaluate several parameters including how the cardiac ultrasound contributes to provider's management plan and assessment of the patient's diagnosis.
This is a prospective observational study design. The investigators will prospectively enroll eligible consecutive patients who present to the emergency department with undifferentiated chest pain or shortness of breath. Patients will be included if a provider has ordered (or is planning on ordering) a cardiac ultrasound as part of the patient's diagnostic workup. Research associates will screen for these two chief complaints and will then approach the ED provider and ask if they ordered or are planning to order a cardiac ultrasound. ED providers may also contact research associates to enroll patients that meet the study criteria.
Pre-ultrasound assessment: After eligibility is determined, a research associate will approach the provider directly involved in the patient's care (Resident or Staff). The provider completing the data collection forms does not need to be the provider who ordered or performed the ultrasound. The provider completing the forms will be an Emergency Medicine 2nd year level resident or above. The provider filling out the data collection form will fill out the pre-ultrasound assessment prior to reviewing the cardiac ultrasound images (either in real-time or on the computer after the ultrasound is completed). The provider will fill out a data collection form that asks about the most likely diagnosis, expected ultrasound findings, and current management plan.
After the ultrasound is completed the same provider will be asked about the most likely diagnosis, observed ultrasound findings, and any new management changes.
Other clinical data that will be collected will include demographic data, vital signs, relevant co-morbidities, imaging results, and lab results from the emergency department visit.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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Minnesota
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Minneapolis, Minnesota, Forente stater, 55415
- Hennepin County Medical Center
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- ED patients with a chief complaint of chest pain or shortness of breath
- Cardiac Ultrasound ordered by provider as part of diagnostic workup
Exclusion Criteria:
- All providers have already reviewed the ultrasound images (unable to obtained pre- ultrasound assessment)
- Age < 18
- Known to be pregnant
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: Kohort
- Tidsperspektiver: Potensielle
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
Observational Cohort
All emergency department patients who had a cardiac ultrasound performed as part of their diagnostic workup
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Incidence of management changes
Tidsramme: 6 hours
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Approximate duration of the emergency department visit
|
6 hours
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Lauren Klein, MD, Hennepin Healthcare Research Institute
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- HSR # 15-4092
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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