- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT02961439
Validation of Epworth Richmond's Echocardiography Education Focused Year (VEREEFY)
The use of echocardiography in intensive care is a developing field. In expert hands echocardiography has proven its utility in diagnosing cardiac pathology, differentiating shock states and in haemodynamic monitoring. However, whether the results obtained by experts can be generalized to trainees or specialists with limited training remains unclear. Further, concerns around training time and cost for intensive care staff have been a factor in limiting the uptake of echocardiography in intensive care.
The investigators aim to assess the diagnostic accuracy of Australian ICU doctors in training after completion of the current minimum training. After completing a structured teaching program and 30 mentored training scans trainees will be assessed on their accuracy with echocardiography. In the research phase trainees will complete a further 40 scans with each one matched with an expect scan. The results from the expert and trainee scans will be compared to determine the trainee's accuracy.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
-
-
Victoria
-
Melbourne, Victoria, Australien, 3121
- Epworth Richmond
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
Registrar Inclusion:
- At least 12 month appointment in Epworth Richmond ICU
- Completion of theoretical component of Epworth Richmond ICU echocardiography program
- Completion of 30 echocardiography scans
Registrar Exclusion:
• Previous experience in echocardiography prior to commencing at Epworth Richmond.
Patient Inclusion
- Patient in ICU or CCU
- 18 years or older
- Not likely to be discharged before completion of the scan
Patient Exclusion
- Likely to be discharged within next two hours
- Atrial fibrillation
- Presence of subcostal or intercostal drains or pneumothorax
- Unable to be consented
- Treating intensivist deems inclusion in study not suitable.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Beobachtungsmodelle: Sonstiges
- Zeitperspektiven: Interessent
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
|---|---|
|
Patient Participants
Patient participants are adult patients in the Epworth Richmond Intensive care Unit.
They are not the focus of the research but rather represent a general population of ICU patients that require echocardiography in the management of their critical illness.
They will be a mix of medical and surgical patients some of whom are receiving mechanical ventilation, have movement restrictions, high BMI or other impediments to performing echocardiography.
|
|
|
Registrar Participants
Registrar participants are doctors in training in ICU.
They have completed a formal echo teaching program and completed a logbook of 30 supervised scans.
They are the focus of the research and are being assessed on their diagnostic accuracy with echocardiography.
|
a year long echo teaching program
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
Agreement between registrar and expert assessment of Left ventricular (LV) function
Zeitfenster: Four months
|
Four months
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
Comparison of expert and registrar quantitative measures of Left vwentricular Internal Diameter in Diastole (LVIDd)
Zeitfenster: Four months
|
Four months
|
|
Comparison of expert and registrar quantitative measures of Left Ventricular Outflow Tract (LVOT) diameter
Zeitfenster: Four months
|
Four months
|
|
Comparison of expert and registrar quantitative measures of Left Ventricular Outflow Tract Velocity Time Integral (LVOT VTI)
Zeitfenster: Four months
|
Four months
|
|
Comparison of expert and registrar quantitative measures of TR V max
Zeitfenster: Four months
|
Four months
|
|
Comparison of expert and registrar quantitative measures of Tricuspid annular Plane Systolic Excursion (TAPSE)
Zeitfenster: Four months
|
Four months
|
|
Comparison of expert and registrar quantitative measures of IVC diameter
Zeitfenster: Four months
|
Four months
|
|
Comparison of expert and registrar qualitative assessment of pericardial fluid
Zeitfenster: Four months
|
Four months
|
|
Comparison of expert and registrar qualitative assessment of Left Ventricle : Right Ventricle size ratio
Zeitfenster: Four months
|
Four months
|
Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Publikationen und hilfreiche Links
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 (Tatsächlich)
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
- EH2016-133
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Produkt, das in den USA hergestellt und aus den USA exportiert wird
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
Klinische Studien zur Schock, kardiogen
-
Biomedizinische Forschungs gmbHMedical University of ViennaAbgeschlossenSepsis | Toxic-Shock-Syndrom