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

This study has been completed.
Sponsor:
Information provided by:
University of Calgary
ClinicalTrials.gov Identifier:
NCT01269931
First received: January 3, 2011
Last updated: NA
Last verified: December 2010
History: No changes posted
  Purpose

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.


Condition Intervention
EBUS-TBNA Training Methods
Procedure: EBUS-TBNA

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Evaluation of Clinical Endobronchial Ultrasound Skills Following Clinical Versus Simulation Training.

Resource links provided by NLM:


Further study details as provided by University of Calgary:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • total learner EBUS-TBNA procedure time [ Time Frame: patients followed for 2 months or until death - measured at patient EBUS-TBNA procedure ] [ Designated as safety issue: No ]
  • time to intubation [ Time Frame: patients followed for 2 months or until death - measured at patient EBUS-TBNA procedure ] [ Designated as safety issue: No ]
  • lymph node ultrasound examination time [ Time Frame: patients followed for 2 months or until death - measured at patient EBUS-TBNA procedure ] [ Designated as safety issue: No ]
  • percentage of successful aspirations [ Time Frame: patients followed for 2 months or until death - measured at patient EBUS-TBNA procedure ] [ Designated as safety issue: No ]
  • number of intubation attempts [ Time Frame: patients followed for 2 months or until death - measured at patient EBUS-TBNA procedure ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • sample adequacy [ Time Frame: patients followed for 2 months or until death - measured at patient EBUS-TBNA procedure ] [ Designated as safety issue: No ]
  • diagnostic yield [ Time Frame: patients followed for 2 months or until death - measured at patient EBUS-TBNA procedure ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • total lymph node biopsy time [ Time Frame: patients followed for 2 months or until death - measured at patient EBUS-TBNA procedure ] [ Designated as safety issue: No ]
  • time to EBUS-TBNA intubation [ Time Frame: patients followed for 2 months or until death - measured at patient EBUS-TBNA procedure ] [ Designated as safety issue: No ]
  • number of unsuccessful biopsies per case [ Time Frame: patients followed for 2 months or until death - measured at patient EBUS-TBNA procedure ] [ Designated as safety issue: No ]
    includes a list of reasons for unsuccessful biopsies: bronchoscope damage, contaminated sample, penetrating far side of lymph node, missing the lymph node, vascular puncture


Enrollment: 24
Study Start Date: June 2010
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01269931

Locations
Canada, Alberta
Dr. David R Stather
Calgary, Alberta, Canada, T2N 4N1
Sponsors and Collaborators
University of Calgary
Investigators
Principal Investigator: David R Stather, MD University of Calgary
  More Information

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

Responsible Party: David Ryan Stather, University of Calgary
ClinicalTrials.gov Identifier: NCT01269931     History of Changes
Other Study ID Numbers: E-23051
Study First Received: January 3, 2011
Last Updated: January 3, 2011
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Calgary:
endobronchial ultrasound
bronchoscopy
education
interventional bronchoscopy
simulation

ClinicalTrials.gov processed this record on September 18, 2014