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

NCT01269931 | Completed DMC

• 1 other identifier: E-23051
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

EBUS-TBNA Training Methods

Keywords

endobronchial ultrasound; bronchoscopy; education; interventional bronchoscopy; simulation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• 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

Study Arms (2)

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

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

Interventions

EBUS-TBNA PROCEDURE

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.

Also known as: - endobronchial ultrasound, - EBUS

Group 1 (EBUS-TBNA simulator training); Group 2 (Clinical EBUS-TBNA training)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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):
• pulmonary medicine trainees with \>30 bronchoscopy procedures experience, \>nine months of pulmonary fellowship training and no clinical EBUS-TBNA experience (n=4)
• lack of informed consent
• 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).
• lack of informed consent

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

Dr. David R Stather

Calgary, Alberta, T2N 4N1, Canada

Location

Related Publications (2)

• 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.

  PMID: 21311171 RESULT

• Stather DR, MacEachern P, Rimmer K, Tremblay A. Assessment of Endobronchial Ultrasound Skills Following Clinical vs Simulator Training. Chest 2010;138:589A

  RESULT

Related Links

• Website for the University of Calgary Interventional Pulmonary Medicine Program

Study Officials

• David R Stather, MD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 3, 2011
• First Posted: January 4, 2011
• Study Start: June 1, 2010
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: January 4, 2011

Record last verified: 2010-12

Locations

CA (1)