Simulation Training for Ultrasound Guided Central Venous Catheter Insertion

This study has been completed.
Sponsor:
Information provided by:
Yale University
ClinicalTrials.gov Identifier:
NCT00919308
First received: June 9, 2009
Last updated: June 11, 2009
Last verified: June 2009
  Purpose

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:

  1. a reduced number of attempts at venous cannulation,
  2. a decreased rate of technical errors and a decreased complication rate based on an independent rater's evaluation using a procedure checklist, and
  3. a decreased time to CVC insertion from opening the catheter kit to placement of sterile dressing as timed by an independent rater.

Condition Intervention
Procedural Skill Competency
Other: Competency based simulation training

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Simulation Training for Ultrasound Guided Central Venous Catheter Insertion

Further study details as provided by Yale University:

Primary Outcome Measures:
  • The failure rate of central venous catheter insertion in the hospital setting on actual patients. [ Time Frame: 21 months (January 2007-September 2008) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 [ Time Frame: 21 months (January 2007-September 2008) ] [ Designated as safety issue: Yes ]

Enrollment: 184
Study Start Date: August 2006
Study Completion Date: June 2009
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
Other: Competency based simulation training
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.

Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00919308

Locations
United States, Connecticut
Yale-New Haven Hospital
New Haven, Connecticut, United States, 06520
Sponsors and Collaborators
Yale University
  More Information

No publications provided by Yale University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Leigh V. Evans MD, Yale University School of Medicine
ClinicalTrials.gov Identifier: NCT00919308     History of Changes
Other Study ID Numbers: 5U18HS016725-02
Study First Received: June 9, 2009
Last Updated: June 11, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
Simulation
Invasive procedures

ClinicalTrials.gov processed this record on August 21, 2014