- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
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Minnesota
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Minneapolis, Minnesota, Vereinigte Staaten, 55415
- Hennepin County Medical Center
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Beobachtungsmodelle: Kohorte
- Zeitperspektiven: Interessent
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
|---|---|
|
Observational Cohort
All emergency department patients who had a cardiac ultrasound performed as part of their diagnostic workup
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Incidence of management changes
Zeitfenster: 6 hours
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Approximate duration of the emergency department visit
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6 hours
|
Mitarbeiter und Ermittler
Ermittler
- Hauptermittler: Lauren Klein, MD, Hennepin Healthcare Research Institute
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- HSR # 15-4092
Plan für individuelle Teilnehmerdaten (IPD)
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