- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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.
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
-
Victoria
-
Melbourne, Victoria, Australia, 3121
- Epworth Richmond
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: Annen
- Tidsperspektiver: Potensielle
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
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
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Agreement between registrar and expert assessment of Left ventricular (LV) function
Tidsramme: Four months
|
Four months
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Comparison of expert and registrar quantitative measures of Left vwentricular Internal Diameter in Diastole (LVIDd)
Tidsramme: Four months
|
Four months
|
|
Comparison of expert and registrar quantitative measures of Left Ventricular Outflow Tract (LVOT) diameter
Tidsramme: Four months
|
Four months
|
|
Comparison of expert and registrar quantitative measures of Left Ventricular Outflow Tract Velocity Time Integral (LVOT VTI)
Tidsramme: Four months
|
Four months
|
|
Comparison of expert and registrar quantitative measures of TR V max
Tidsramme: Four months
|
Four months
|
|
Comparison of expert and registrar quantitative measures of Tricuspid annular Plane Systolic Excursion (TAPSE)
Tidsramme: Four months
|
Four months
|
|
Comparison of expert and registrar quantitative measures of IVC diameter
Tidsramme: Four months
|
Four months
|
|
Comparison of expert and registrar qualitative assessment of pericardial fluid
Tidsramme: Four months
|
Four months
|
|
Comparison of expert and registrar qualitative assessment of Left Ventricle : Right Ventricle size ratio
Tidsramme: Four months
|
Four months
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Publikasjoner og nyttige lenker
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 (Faktiske)
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
- EH2016-133
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
produkt produsert i og eksportert fra USA
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .