Endotracheal IntubationNCT02699242
Does Training on a Virtual Reality Bronchoscopy Simulator Improve Performance of Bronchoscopic Intubation in Patients?
A study testing Simulator (ORSIM) training in people with Endotracheal Intubation, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
The aim of the study is to study whether training by residents or anesthesia assistants, on a recently introduced virtual-reality bronchoscopic simulator (ORSIM) improves performance of fiberoptic intubation in patients. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Endotracheal Intubation
- What is being tested?
- Simulator (ORSIM) training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2015to Jun 2016
- Phase
- Interventional
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject:
- anesthesia/surgery/emergency/critical care residents or anesthesia assistants who have performed less than 5 Fiberoptic intubations
Who cannot join
- experience with bronchoscopy simulator or 5 or more FOB intubations
- Patient:
- Anticipated difficult airway
- Mallampati Grade (MPG) >III
- Body Mass Index (BMI) >30
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the study is to study whether training by residents or anesthesia assistants, on a recently introduced virtual-reality bronchoscopic simulator (ORSIM) improves performance of fiberoptic intubation in patients.
Read the detailed description
Traditionally, fiber optic bronchoscopy (FOB) intubation has been taught in a see one, do one basis. Modern training method in skill acquisition involves the use of simulators. Recently a portable, computer based, bronchoscopic simulator (ORSIM) was developed. The investigators hypothesized that operators trained with the ORSIM simulator will be more proficient in performing asleep FOB intubation than those trained with didactic teaching alone.
This randomized trial involves 34 consented residents or anesthesia assistants (AAs). In preparation, each consented person will view a teaching video of FOB intubation and tips. They will then perform an asleep FOBI in the OR under a staff anesthesiologist's supervision who's familiar with the study. Those who are randomized to the ORSIM group with undergo simulator training of 30-60 min. Those in the Didactic group will not undergo further training. Within about a week, the resident/AA will perform another asleep FOB intubation.
The study results will impact on how FOB intubation will be taught effectively in the future.
- Conditions
- Endotracheal Intubation
- Being tested
- Simulator (ORSIM) training
- Keywords
- Fiberoptic intubation Training Simulation Performance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simulator (ORSIM) trainingDevice
The simulator/intervention group will undergo training on the virtual reality bronchoscopic simulator (ORSIM) for 60 minutes before the subjects perform the 2nd Fiber optic intubation
| Study group | Role | What they receive |
|---|---|---|
| Simulator arm | Experimental | In the Simulation arm group the subjects will be trained on the virtual reality bronchoscopic simulator (ORSIM simulator) for up to 60 minutes as active intervention, before they undertake the 2nd Fiber optic intubations. Receives: Device: Simulator (ORSIM) training |
| Control arms | No intervention | The control arm will be exposed only to the didactic teaching. The subjects will not undergo simulator training before undergoing 2nd fiber optic intubations. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance of Fiberoptic intubation assessed by validated 40 point Global Rating Scale (GRS)
Measured: 1 year
Secondary outcomes (2)
Success/Failure of Fiberoptic intubation
Measured: 1 year
The duration (in seconds) of the Fiberoptic intubation
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2016 (estimated)
- Study startApr 2015
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Endotracheal IntubationStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Wong, University Health Network, Toronto
- Investigators
- David T Wong, MD, Principal investigator, Department of Anesthesiology, Toronto Western Hospital, 399, Bathurst St., MC2-405, Toronto, ON, Canada M5T 1S8
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02699242
- Sponsor's protocol ID
- 13-6321-BE
- Status last verified
- Jun 2017
- First submitted
- 14 Feb 2016
- Last updated
- 21 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
Wong DT, Mehta A, Singh KP, Leong SM, Ooi A, Niazi A, You-Ten E, Okrainec A, Patel R, Singh M, Wong J. The effect of virtual reality bronchoscopy simulator training on performance of bronchoscopic-guided intubation in patients: A randomised controlled trial. Eur J Anaesthesiol. 2019 Mar;36(3):227-233. doi: 10.1097/EJA.0000000000000890.
PubMed 30234669
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Training on a Virtual Reality Bronchoscopy Simulator Improve Performance of Bronchoscopic Intubation in Patients?
- ClinicalTrials.gov ID
- NCT02699242
- Acronym / sponsor ID
- 13-6321-BE
- Conditions
- Endotracheal Intubation
- Keywords
- Fiberoptic intubation Training Simulation Performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 4 Mar 2016 (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.
The aim of the study is to study whether training by residents or anesthesia assistants, on a recently introduced virtual-reality bronchoscopic simulator (ORSIM) improves performance of fiberoptic intubation in patients.
Detailed description
Traditionally, fiber optic bronchoscopy (FOB) intubation has been taught in a see one, do one basis. Modern training method in skill acquisition involves the use of simulators. Recently a portable, computer based, bronchoscopic simulator (ORSIM) was developed. The investigators hypothesized that operators trained with the ORSIM simulator will be more proficient in performing asleep FOB intubation than those trained with didactic teaching alone.
This randomized trial involves 34 consented residents or anesthesia assistants (AAs). In preparation, each consented person will view a teaching video of FOB intubation and tips. They will then perform an asleep FOBI in the OR under a staff anesthesiologist's supervision who's familiar with the study. Those who are randomized to the ORSIM group with undergo simulator training of 30-60 min. Those in the Didactic group will not undergo further training. Within about a week, the resident/AA will perform another asleep FOB intubation.
The study results will impact on how FOB intubation will be taught effectively in the future.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Simulator arm | Experimental | Device: Simulator (ORSIM) trainingIn the Simulation arm group the subjects will be trained on the virtual reality bronchoscopic simulator (ORSIM simulator) for up to 60 minutes as active intervention, before they undertake the 2nd Fiber optic intubations. |
| Control arms | No intervention | –The control arm will be exposed only to the didactic teaching. The subjects will not undergo simulator training before undergoing 2nd fiber optic intubations. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- anesthesia/surgery/emergency/critical care residents or anesthesia assistants who have performed less than 5 Fiberoptic intubations
Key exclusion criteria (5 listed)
- experience with bronchoscopy simulator or 5 or more FOB intubations
- Anticipated difficult airway
- Mallampati Grade (MPG) >III
- Body Mass Index (BMI) >30
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 |
|---|---|---|
| Simulator (ORSIM) trainingThe simulator/intervention group will undergo training on the virtual reality bronchoscopic simulator (ORSIM) for 60 minutes before the subjects perform the 2nd Fiber optic intubation | Device | Simulator arm |
Primary outcome
Performance of Fiberoptic intubation assessed by validated 40 point Global Rating Scale (GRS)
Time frame: 1 year
2 secondary outcomes
Success/Failure of Fiberoptic intubation
Time frame: 1 year
The duration (in seconds) of the Fiberoptic intubation
Time frame: 1 year
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 21 Jun 2017.
- Derived from this study: PubMed 30234669Wong DT, Mehta A, Singh KP, Leong SM, Ooi A, Niazi A, You-Ten E, Okrainec A, Patel R, Singh M, Wong J. The effect of virtual reality bronchoscopy simulator training on performance of bronchoscopic-guided intubation in patients: A randomised controlled trial. Eur J Anaesthesiol. 2019 Mar;36(3):227-233. doi: 10.1097/EJA.0000000000000890.
- Individual participant dataSharing planned: Yes
Related trials for Endotracheal Intubation
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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 T Wong, MD principal investigator
Department of Anesthesiology, Toronto Western Hospital, 399, Bathurst St., MC2-405, Toronto, ON, Canada M5T 1S8
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simulator (ORSIM) training in people with Endotracheal Intubation, run by University Health Network, Toronto 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 2 inclusion and 5 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 21 Jun 2017. 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?
Performance of Fiberoptic intubation assessed by validated 40 point Global Rating Scale (GRS) (time frame: 1 year). 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 NCT02699242, which also lists 1 linked publication.
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 21 Jun 2017.