Completed

NCT Number: NCT00919308

Simulation Training for Ultrasound Guided Central Venous Catheter Insertion

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Procedural Skill Competency

Sex eligibility

All sexes

Study type

Observational

Primary location

Yale-New Haven Hospital

New Haven, Connecticut, 06520, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Competency based simulation training

Other

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.

Primary outcomes

The failure rate of central venous catheter insertion in the hospital setting on actual patients.

Time frame: 21 months (January 2007-September 2008)

Secondary outcomes

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)

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

Agency for Healthcare Research and Quality (AHRQ)

Registry information

Important dates

Study start: 2006
Primary completion: 2008
Study completion: 2009
First posted: Jun 12, 2009
Registry last updated: Mar 31, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.