Evaluation of Clinical Endobronchial Ultrasound Skills Following Clinical Versus Simulation Training.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- total learner EBUS-TBNA procedure time/number of successful aspirations
研究概览
简要总结
Bronchoscopy is a procedure whereby a small flexible camera is used to inspect and biopsy abnormalities in the lungs. Linear endobronchial ultrasound with transbronchial needle aspiration (EBUS-TBNA) is a revolutionary diagnostic pulmonary procedure that allows visualization and safe, accurate biopsies of structures in and around the lungs during bronchoscopy. EBUS-TBNA can be challenging to learn.
Historically, bronchoscopy has been taught using an apprenticeship model, whereby trainees practice on patients. With the introduction of computer bronchoscopy simulators, trainees can now obtain basic bronchoscopy skills by practicing on the simulator, rather than practicing on patients.
This study aims to compare trainee EBUS-TBNA performance during actual procedures on patients, following training with a computer EBUS-TBNA simulator versus conventional clinical EBUS-TBNA training (trainees taught by practicing on patients). Our hypothesis is that the skills learned using a computer EBUS-TBNA simulator are transferable to clinical EBUS-TBNA performance, meaning that using a computer EBUS-TBNA simulator for training is just as good as learning these skills by practicing on patients.
The use of EBUS-TBNA simulators for training could have the advantage of minimizing the burden of procedural learning on patients.
详细描述
Learners in Group 1 undergo training on the EBUS-TBNA simulator before performing EBUS-TBNA on the study patients.
Learners in Group 2 completed a one month clinical Interventional Pulmonary Medicine rotation. During this rotation, they completed ≥15 and ≤25 EBUS-TBNA clinical procedures with an Interventional Pulmonologist experienced in EBUS-TBNA.
Learners in both groups receive a standard EBUS-TBNA knowledge review process before their patient care EBUS-TBNA experience. This includes a series of oral questions and a written lymph node staging diagram which they need to correctly answer, prior to performing EBUS-TBNA on study patients. Learners in Group 2 complete this review process informally on a number of occasions during their Interventional Pulmonary Medicine rotations. Learners in Group 1 formally undergo this review process 5 times during the EBUS-TBNA simulation training.
Bronchoscopy is performed utilizing a 1T-160 Olympus video bronchoscope (Olympus Canada, Markham, Canada) for the airway examination and a BF-UC160F-OL8 (EBUS bronchoscope - Olympus Canada, Markham, Canada) for the EBUS-TBNA procedure. In order to standardize for differences in bronchoscopy method, a single attending Interventional Pulmonologist (IP) is responsible for performing all 16 bronchoscopies with the learners. The complete airway examination and any additional non-EBUS-TBNA samples are performed by the attending IP. All endobronchial ultrasound bronchoscopy performance metrics are recorded by another IP not involved in the procedure on a standard data sheet.
EBUS-TBNA is performed by the learner with 3 specific goals:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •suspected lung cancer patients with mediastinal adenopathy
- •at least 2 enlarged mediastinal or hilar lymph nodes (one >1.0 cm and one >1.5 cm in short axis on CT Chest, one of the lymph nodes must be in position 7 or 4R
- •eighteen years of age or older
排除标准
- •Lack of informed consent
- •any contraindication to bronchoscopy
- •any significant severe co-morbidities (i.e. severe obstructive lung disease, active cardiac disease such as angina)
- •Group 1 (EBUS-TBNA simulator training):
- •Inclusion Criteria:
- •pulmonary medicine trainees with >30 bronchoscopy procedures experience, >nine months of pulmonary fellowship training and no clinical EBUS-TBNA experience (n=4)
- •Exclusion Criteria:
- •lack of informed consent
- •Group 2 (Clinical EBUS-TBNA training):
- •Inclusion Criteria:
- •pulmonary medicine trainees in the 2nd half of their final year of pulmonary training or recent graduates (within one year), with >50 bronchoscopy procedures experience who completed a one-month elective with the Interventional Pulmonary Medicine (IPM) service with ≥15 and ≤25 EBUS-TBNA procedures experience (n=4).
- •Exclusion Criteria:
- •lack of informed consent
结局指标
主要结局
total learner EBUS-TBNA procedure time/number of successful aspirations
时间窗: patients followed for 2 months or until death - measured at patient EBUS-TBNA procedure
次要结局
- total learner EBUS-TBNA procedure time(patients followed for 2 months or until death - measured at patient EBUS-TBNA procedure)
- time to intubation(patients followed for 2 months or until death - measured at patient EBUS-TBNA procedure)
- lymph node ultrasound examination time(patients followed for 2 months or until death - measured at patient EBUS-TBNA procedure)
- percentage of successful aspirations(patients followed for 2 months or until death - measured at patient EBUS-TBNA procedure)
- number of unsuccessful biopsies per case(patients followed for 2 months or until death - measured at patient EBUS-TBNA procedure)
- number of intubation attempts(patients followed for 2 months or until death - measured at patient EBUS-TBNA procedure)
- percentage of lymph node stations correctly identified during lymph node ultrasound examination(patients followed for 2 months or until death - measured at patient EBUS-TBNA procedure)
- number of instructional comments required by the attending pulmonologist(patients followed for 2 months or until death - measured at patient EBUS-TBNA procedure)
- sample adequacy(patients followed for 2 months or until death - measured at patient EBUS-TBNA procedure)
- diagnostic yield(patients followed for 2 months or until death - measured at patient EBUS-TBNA procedure)
- expert respiratory therapist subjective EBUS-TBNA technical skill assessment(patients followed for 2 months or until death - measured at patient EBUS-TBNA procedure)
- total lymph node biopsy time(patients followed for 2 months or until death - measured at patient EBUS-TBNA procedure)
- time to EBUS-TBNA intubation(patients followed for 2 months or until death - measured at patient EBUS-TBNA procedure)