EBUS-TBNA Training MethodsNCT01269931
Evaluation of Clinical Endobronchial Ultrasound Skills Following Clinical Versus Simulation Training.
An observational study of EBUS-TBNA Training Methods, run by University of Calgary at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- EBUS-TBNA Training Methods
- What is being tested?
- EBUS-TBNA
- Type of treatment
- Surgery or procedure
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2010to Nov 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
- pulmonary medicine trainees with >30 bronchoscopy procedures experience, >nine months of pulmonary fellowship training and no clinical EBUS-TBNA experience (n=4)
- 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).
Who cannot join
- 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):
- lack of informed consent
- Group 2 (Clinical EBUS-TBNA training):
- lack of informed consent
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the 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:
- Intubation with the EBUS-TBNA bronchoscope.
- Lymph Node Ultrasound Examination. Identify 5 major lymph node stations (11R, 4R, 7, 4L, 11L).
- 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.
- Conditions
- EBUS-TBNA Training Methods
- Being tested
- EBUS-TBNA
- Keywords
- endobronchial ultrasound, bronchoscopy, education, interventional bronchoscopy, simulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EBUS-TBNAProcedure or surgery
Also called - endobronchial ultrasound, - EBUS
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Procedure: EBUS-TBNA |
What is being measured
The primary outcome is the main question the study is designed to answer.
total learner EBUS-TBNA procedure time/number of successful aspirations
Measured: patients followed for 2 months or until death - measured at patient EBUS-TBNA procedure
Secondary outcomes (13)
total learner EBUS-TBNA procedure time
Measured: patients followed for 2 months or until death - measured at patient EBUS-TBNA procedure
time to intubation
Measured: patients followed for 2 months or until death - measured at patient EBUS-TBNA procedure
lymph node ultrasound examination time
Measured: patients followed for 2 months or until death - measured at patient EBUS-TBNA procedure
percentage of successful aspirations
Measured: patients followed for 2 months or until death - measured at patient EBUS-TBNA procedure
number of intubation attempts
Measured: 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
Measured: patients followed for 2 months or until death - measured at patient EBUS-TBNA procedure
number of instructional comments required by the attending pulmonologist
Measured: patients followed for 2 months or until death - measured at patient EBUS-TBNA procedure
sample adequacy
Measured: patients followed for 2 months or until death - measured at patient EBUS-TBNA procedure
diagnostic yield
Measured: patients followed for 2 months or until death - measured at patient EBUS-TBNA procedure
expert respiratory therapist subjective EBUS-TBNA technical skill assessment
Measured: patients followed for 2 months or until death - measured at patient EBUS-TBNA procedure
total lymph node biopsy time
Measured: patients followed for 2 months or until death - measured at patient EBUS-TBNA procedure
time to EBUS-TBNA intubation
Measured: 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
Measured: patients followed for 2 months or until death - measured at patient EBUS-TBNA procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2011 (estimated)
- Study startJun 2010
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for EBUS-TBNA Training MethodsStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Investigators
- David R Stather, MD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01269931
- Sponsor's protocol ID
- E-23051
- Status last verified
- Dec 2010
- First submitted
- 3 Jan 2011
- Last updated
- 4 Jan 2011
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 21311171Stather DR, MacEachern P, Rimmer K, Tremblay A. Assessment of Endobronchial Ultrasound Skills Following Clinical vs Simulator Training. Chest 2010;138:589A
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Clinical Endobronchial Ultrasound Skills Following Clinical Versus Simulation Training.
- ClinicalTrials.gov ID
- NCT01269931
- Acronym / sponsor ID
- E-23051
- Conditions
- EBUS-TBNA Training Methods
- Keywords
- endobronchial ultrasound, bronchoscopy, education, interventional bronchoscopy, simulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 4 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- Intubation with the EBUS-TBNA bronchoscope.
- Lymph Node Ultrasound Examination. Identify 5 major lymph node stations (11R, 4R, 7, 4L, 11L).
- 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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (EBUS-TBNA simulator training) | – | Procedure: EBUS-TBNAGroup 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). |
| Group 2 (Clinical EBUS-TBNA training) | – | Procedure: EBUS-TBNAGroup 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
- pulmonary medicine trainees with >30 bronchoscopy procedures experience, >nine months of pulmonary fellowship training and no clinical EBUS-TBNA experience (n=4)
- 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).
Key exclusion criteria (8 listed)
- 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)
- lack of informed consent
- lack of informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EBUS-TBNAAlso: - endobronchial ultrasound, - EBUSEndobronchial 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. | Procedure or surgery | Group 1 (EBUS-TBNA simulator training), Group 2 (Clinical EBUS-TBNA training) |
Primary outcome
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
13 secondary outcomes
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
Time frame: patients followed for 2 months or until death - measured at patient EBUS-TBNA procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2011.
- Results publication: PubMed 21311171Stather 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.
- Results publicationStather DR, MacEachern P, Rimmer K, Tremblay A. Assessment of Endobronchial Ultrasound Skills Following Clinical vs Simulator Training. Chest 2010;138:589A
- Website for the University of Calgary Interventional Pulmonary Medicine ProgramLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David R Stather, MD principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of EBUS-TBNA Training Methods, run by University of Calgary at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01269931, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2011.