Evaluation of Clinical Endobronchial Ultrasound Skills Following Clinical Versus Simulation Training.

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.

Study Overview

• Status: Completed
• Conditions: EBUS-TBNA Training Methods
• Intervention / Treatment: Procedure: EBUS-TBNA

Detailed Description

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:

1. Intubation with the EBUS-TBNA bronchoscope.
2. Lymph Node Ultrasound Examination. Identify 5 major lymph node stations (11R, 4R, 7, 4L, 11L).
3. Sampling of two lymph nodes per patient. The order and location of lymph nodes was at the discretion of the attending IP. Following the biopsy of two lymph nodes stations by the learner, the attending IP completes the rest of the procedure, including any further biopsies that are necessary. The learner is expected to perform 3 successful passes in each of the two lymph nodes, with a total of 5 allowed attempts per lymph node station.

The learner procedure time starts at the time of the first intubation attempt with the EBUS-TBNA bronchoscope, and finishes with the last biopsy of the second lymph node station. If other clinically important lymph nodes are present or if more than 3 successful aspirations are desired, the stopwatch is stopped while the attending IP performed the biopsies.

Samples are placed in alcohol preservative and sent to the cytopathology lab as per our routine procedure. No indication as to group allocation is available to the clinical cytopathologist interpreting the samples.

To be enrolled, patients and learners must give written informed consent.

The EBUS-TBNA simulator used for this study is the AccuTouch Flexible Bronchoscopy Simulator (CAE Healthcare, Montreal, Canada), equipped with an EBUS-TBNA module. This simulator has been described in detail previously in the articles cited at the end of this ClinicalTrials.gov entry.

• Study Type: Observational
• Enrollment (Actual): 24

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4N1
      • Dr. David R Stather

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

A prospective, comparative study of 2 groups of learners, performing EBUS-TBNA on patients. Patients are randomly assigned to undergo bronchoscopy with a trainee from Group 1 or Group 2. Learners are pulmonary medicine trainees at the University of Calgary. Patients are suspected lung cancer patients with mediastinal adenopathy seen by the University of Calgary Interventional Pulmonary Medicine service.

Description

Patients:

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Learners:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1 (EBUS-TBNA simulator training); Group 1 (EBUS-TBNA simulator training): pulmonary medicine trainees with >30 bronchoscopy procedures experience, >nine months of pulmonary fellowship training and no clinical EBUS-TBNA experience (n=4).	Procedure: EBUS-TBNA; Endobronchial ultrasound with transbronchial needle aspiration (EBUS-TBNA) is a revolutionary diagnostic pulmonary procedure that allows visualization and safe, accurate biopsies of intra-thoracic structures during bronchoscopy. Patients enrolled in this study at the University of Calgary would have undergone this procedure regardless of being enrolled in this study. The purpose of the study was to prospectively compare the EBUS-TBNA performance of 2 groups of learners, performing EBUS-TBNA on patients, who had received to different methods of EBUS-TBNA training. Patients were randomly assigned to undergo bronchoscopy with a trainee from Group 1 or Group 2.; Other Names: - endobronchial ultrasound; - EBUS
Group 2 (Clinical EBUS-TBNA training); Group 2 (Clinical EBUS-TBNA training): 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).	Procedure: EBUS-TBNA; Endobronchial ultrasound with transbronchial needle aspiration (EBUS-TBNA) is a revolutionary diagnostic pulmonary procedure that allows visualization and safe, accurate biopsies of intra-thoracic structures during bronchoscopy. Patients enrolled in this study at the University of Calgary would have undergone this procedure regardless of being enrolled in this study. The purpose of the study was to prospectively compare the EBUS-TBNA performance of 2 groups of learners, performing EBUS-TBNA on patients, who had received to different methods of EBUS-TBNA training. Patients were randomly assigned to undergo bronchoscopy with a trainee from Group 1 or Group 2.; Other Names: - endobronchial ultrasound; - EBUS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
total learner EBUS-TBNA procedure time/number of successful aspirations	patients followed for 2 months or until death - measured at patient EBUS-TBNA procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 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
number of unsuccessful biopsies per case	includes a list of reasons for unsuccessful biopsies: bronchoscope damage, contaminated sample, penetrating far side of lymph node, missing the lymph node, vascular puncture	patients followed for 2 months or until death - measured at patient EBUS-TBNA procedure

Collaborators and Investigators

• Sponsor: University of Calgary
• Investigators: Principal Investigator: David R Stather, MD, University of Calgary

Publications and helpful links

General Publications

• Stather DR, Maceachern P, Rimmer K, Hergott CA, Tremblay A. Validation of an endobronchial ultrasound simulator: differentiating operator skill level. Respiration. 2011;81(4):325-32. doi: 10.1159/000323520. Epub 2011 Feb 9.
• Stather DR, MacEachern P, Rimmer K, Tremblay A. Assessment of Endobronchial Ultrasound Skills Following Clinical vs Simulator Training. Chest 2010;138:589A

Helpful Links

• Website for the University of Calgary Interventional Pulmonary Medicine Program

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Actual): November 1, 2010
• Study Completion (Actual): November 1, 2010

Study Registration Dates

• First Submitted: January 3, 2011
• First Submitted That Met QC Criteria: January 3, 2011
• First Posted (Estimate): January 4, 2011

Study Record Updates

• Last Update Posted (Estimate): January 4, 2011
• Last Update Submitted That Met QC Criteria: January 3, 2011
• Last Verified: December 1, 2010

More Information

Terms related to this study

• Keywords: bronchoscopy; simulation; education; endobronchial ultrasound; interventional bronchoscopy
• Other Study ID Numbers: E-23051