Simulation Training for Ultrasound Guided Central Venous Catheter Insertion
27. mars 2020 oppdatert av: Yale University
Hypothesis #1: Residents who complete a structured, ultrasound guided simulation training protocol will have superior skills at central venous catheter (CVC) insertion on actual patients as compared to residents who are trained in CVC insertion according to the traditional, bedside apprenticeship model as measured by a reduced failure rate at CVC insertion.
Hypothesis #2: Residents who complete a structured, ultrasound guided simulation training protocol will have superior skills at CVC insertion on actual patients as compared to residents who are trained in CVC insertion according to the traditional, bedside apprenticeship model as measured by:
- a reduced number of attempts at venous cannulation,
- a decreased rate of technical errors and a decreased complication rate based on an independent rater's evaluation using a procedure checklist, and
- a decreased time to CVC insertion from opening the catheter kit to placement of sterile dressing as timed by an independent rater.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Resident education has traditionally devoted itself to knowledge acquisition rather than defined levels of clinical competence.
Currently, inexperienced physicians are trained to perform invasive procedures such as central venous catheter (CVC) insertion according to the bedside, apprenticeship model, gaining expertise on real patients in neither a rigorous nor standardized manner.
Simulators may ease trainees' transition to actual patients and avoid adverse events.
This project aims to investigate the efficacy of a structured simulation training protocol in ultrasound guided CVC insertion for resident physicians.
The specific aims are to compare: (1) the failure rate of CVC insertion, and (2) the number of attempts at venous cannulation, rates of technical errors and complications of CVC insertion, and time to CVC insertion on actual patients between residents who completed a structured, hands-on simulation training protocol (intervention group) and those who are trained according to the traditional, bedside apprenticeship model (control group).
We hypothesize that the intervention group will obtain superior skills at CVC insertion on actual patients as compared to the control group as measured by: (1) a reduced failure rate at CVC insertion, (2) a) a reduced number of attempts at venous cannulation b) a decreased rate of technical errors and complications and c) a decreased time to insertion based on an independent rater's evaluation using a procedure checklist.
Studietype
Observasjonsmessig
Registrering (Faktiske)
184
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Connecticut
-
New Haven, Connecticut, Forente stater, 06520
- Yale-New Haven Hospital
-
-
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
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
PGY-1 or PGY-2 resident status in the Yale-New Haven Hospital Emergency Medicine, Internal Medicine, General Surgery, Obstetric and Gynecology and Anesthesia residency programs.
Beskrivelse
Inclusion Criteria:
Eligibility is determined by the program director of the residency programs.
- The racial, gender, and ethnic characteristics of the proposed subject population reflects the demographics of the interns and residents within the specialties of Emergency Medicine, Internal Medicine, General Surgery, Obstetrics and Gynecology and Anesthesia.
- None of the subjects are minors and all are in sufficient health to participate in their residency programs.
Exclusion Criteria:
- Of eligible subjects, the only exclusion criterion is unwillingness to participate in the project.
- No exclusion criteria shall be based on race, gender, or ethnicity.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: Case-Control
- Tidsperspektiver: Potensielle
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
Control, traditional bedside training
Postgraduate year 1 and 2 residents who are trained in central venous catheter insertion according to the traditional, bedside apprenticeship model.
|
|
|
Simulation training
Postgraduate year 1 and 2 residents who complete a hands-on ultrasound guided simulation training protocol on a partial task training simulator until competence is achieved as measured by: the ability to cannulate a simulated vein under ultrasound guidance on first pass in five consecutive attempts and correct insertion of a central venous cannulator on a partial task training simulator with no technical errors.
|
Completion of a hands-on ultrasound guided simulation training protocol on a partial task training simulator until competence is achieved as measured by the ability to cannulate a simulated vein under ultrasound guidance on first pass in five consecutive attempts and correct insertion of a central venous catheter on a partial task training simulator with no technical errors.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
The failure rate of central venous catheter insertion in the hospital setting on actual patients.
Tidsramme: 21 months (January 2007-September 2008)
|
21 months (January 2007-September 2008)
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
The number of attempts at venous cannulation, and the rate of technical errors and complication rate of central venous catheter insertion in the hospital setting on actual patients
Tidsramme: 21 months (January 2007-September 2008)
|
21 months (January 2007-September 2008)
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. august 2006
Primær fullføring (Faktiske)
1. september 2008
Studiet fullført (Faktiske)
1. juni 2009
Datoer for studieregistrering
Først innsendt
9. juni 2009
Først innsendt som oppfylte QC-kriteriene
11. juni 2009
Først lagt ut (Anslag)
12. juni 2009
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
31. mars 2020
Siste oppdatering sendt inn som oppfylte QC-kriteriene
27. mars 2020
Sist bekreftet
1. juni 2009
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- 0605001388
- 5U18HS016725-02 (U.S.A. AHRQ-stipend/kontrakt)
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. .