An observational study in EBUS-TBNA Training Methods, sponsored by University of Calgary. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-01-04.
Sponsored by University of Calgary · Observational
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.
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:
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.
University of Calgary is the lead sponsor of 686 studies on the registry; 189 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 2 (20%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Patients:
Inclusion Criteria:
Exclusion Criteria:
Learners:
Group 1 (EBUS-TBNA simulator training):
Inclusion Criteria:
Exclusion Criteria:
Group 2 (Clinical EBUS-TBNA training):
Inclusion Criteria:
Exclusion Criteria:
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): 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.
Also known as: - endobronchial ultrasound, - EBUS
total learner EBUS-TBNA procedure time/number of successful aspirations
Time frame: patients followed for 2 months or until death - measured at patient EBUS-TBNA procedure
total learner EBUS-TBNA procedure time
Time frame: patients followed for 2 months or until death - measured at patient EBUS-TBNA procedure
time to intubation
Time frame: patients followed for 2 months or until death - measured at patient EBUS-TBNA procedure
lymph node ultrasound examination time
Time frame: patients followed for 2 months or until death - measured at patient EBUS-TBNA procedure
percentage of successful aspirations
Time frame: patients followed for 2 months or until death - measured at patient EBUS-TBNA procedure
number of intubation attempts
Time frame: 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
Time frame: patients followed for 2 months or until death - measured at patient EBUS-TBNA procedure
number of instructional comments required by the attending pulmonologist
Time frame: patients followed for 2 months or until death - measured at patient EBUS-TBNA procedure
sample adequacy
Time frame: patients followed for 2 months or until death - measured at patient EBUS-TBNA procedure
diagnostic yield
Time frame: patients followed for 2 months or until death - measured at patient EBUS-TBNA procedure
expert respiratory therapist subjective EBUS-TBNA technical skill assessment
Time frame: patients followed for 2 months or until death - measured at patient EBUS-TBNA procedure
total lymph node biopsy time
Time frame: patients followed for 2 months or until death - measured at patient EBUS-TBNA procedure
time to EBUS-TBNA intubation
Time frame: 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
Time frame: patients followed for 2 months or until death - measured at patient EBUS-TBNA procedure
This study is completed, as verified in Dec 2010. You cannot join it, but the record below documents what was studied.
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University of Calgary