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Simulation Training for Ultrasound Guided Central Venous Catheter Insertion

2020年3月27日 更新者: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:

  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.

研究概览

详细说明

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.

研究类型

观察性的

注册 (实际的)

184

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Connecticut
      • New Haven、Connecticut、美国、06520
        • Yale-New Haven Hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人
  • 年长者

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

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.

描述

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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 观测模型:病例对照
  • 时间观点:预期

队列和干预

团体/队列
干预/治疗
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.

研究衡量的是什么?

主要结果指标

结果测量
大体时间
The failure rate of central venous catheter insertion in the hospital setting on actual patients.
大体时间:21 months (January 2007-September 2008)
21 months (January 2007-September 2008)

次要结果测量

结果测量
大体时间
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
大体时间:21 months (January 2007-September 2008)
21 months (January 2007-September 2008)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2006年8月1日

初级完成 (实际的)

2008年9月1日

研究完成 (实际的)

2009年6月1日

研究注册日期

首次提交

2009年6月9日

首先提交符合 QC 标准的

2009年6月11日

首次发布 (估计)

2009年6月12日

研究记录更新

最后更新发布 (实际的)

2020年3月31日

上次提交的符合 QC 标准的更新

2020年3月27日

最后验证

2009年6月1日

更多信息

与本研究相关的术语

其他研究编号

  • 0605001388
  • 5U18HS016725-02 (美国 AHRQ 拨款/合同)

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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