AnesthesiaNCT03929315
3D OLV Training Intervention for Pediatric Anesthesia Trainees
An observational study of Anesthesia, run by Clyde Matava at 1 site in Canada.
Trial summary
One lung ventilation (OLV) in neonates and children is an advanced skill that is necessary for delivery of safe and quality anesthetic care. The current model of training for OLV in the paediatric patient is composed of the apprenticeship model. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Anesthesia
- What is being tested?
- OLV technique on tracheo-bronchial model
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- 5 Apr 2023to 5 Apr 2023
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: pediatric anesthesia trainees at the Hospital for Sick Children, Toronto
Who may be able to join
- Pediatric residents and fellows from the Hospital for Sick Children, Toronto
Who cannot join
- Refusal to participate in study
- Previous experience with at most two OLV in children
- Previous experience with at most two OLV in manikins
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Randomised Control Trial of Competency Metrics and Educational Interventions in the Learning of One Lung Ventilation Techniques in Children Using Low-cost 3D Printed Tracheo-bronchial Models Among Pediatric Anesthesia Trainees
One lung ventilation (OLV) in neonates and children is an advanced skill that is necessary for delivery of safe and quality anesthetic care. The current model of training for OLV in the paediatric patient is composed of the apprenticeship model. Trainees learn the techniques of doing the procedure when they encounter a case that allows for it. The model of training is often inadequate for mastery of skills such as OLV as children in this population often have severe debilitating disease often requiring the most experienced anesthesiologist to perform OLV. This limits the training exposure of anesthesia trainees.
Read the detailed description
Each participant will be subjected to three learning sessions on a 6 year old tracheo-bronchial model. Learning will either be spaced (1 week between learning/testing sessions) or non-spaced (30 minutes between learning/testing sessions). They will have 20 minutes to practice on this model before they are asked to perform the OLV on a younger tracheo-bronchial model (2 yrs, 3 months, 6 weeks). After each testing session, the participants will be provided with feedback. After all learning/testing sessions take place, the participants will be asked to complete a retention test on the 6 week old model six weeks after their last session.
- Conditions
- Anesthesia
- Being tested
- OLV technique on tracheo-bronchial model
- Keywords
- one lung ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OLV technique on tracheo-bronchial modelBehavioural
Models will range in size from 6 yrs to 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Non-spaced learning | Learning/testing sessions will take place within 30 minutes of one another Receives: Behavioral: OLV technique on tracheo-bronchial model | |
| Spaced learning | Learning/testing sessions will take place 1 week after one another Receives: Behavioral: OLV technique on tracheo-bronchial model |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time
Seconds it took for correct placement of OLV
Measured: Day 1, after each learning session
Time
Seconds in took for correct placement of OLV
Measured: Week 6 or 9
Secondary outcomes (8)
Attempts
Number of attempts per procedure
Measured: Week 6 or 9
Wrong entry
Number of entries into wrong bronchus
Measured: Week 6 or 9
Red-outs
Number of red-outs
Measured: Week 6 or 9
Wall collisions
Number of wall collisions
Measured: Week 6 or 9
Qualitative endoscopic assessment
Measured using Global Rating Scale of Fibreoptic Bronchoscope Manipulation, on a scale of 4-20, where 4=novice and 20=expert
Measured: Week 6 or 9
Overall rating of performance
Measured using Visual Analogue Scale, on a scale of 0-100 where 0=novice and 100=expert
Measured: Week 6 or 9
Satisfaction with task load
Measured using Task Load Index, on a scale of 0-100, where 0=very low and 100=very high
Measured: Day 1 or Weeks 1-3
Satisfaction with usability
Measured using System Usability Scale, on a scale of 5-50
Measured: Day 1 or Weeks 1-3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2019
- Study start5 Apr 2023
- Primary completion5 Apr 2023
- Study completion5 Apr 2023
Why it stopped: COVID made it difficult to access the materials and participants required for this study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clyde Matava
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Clyde Matava, The Hospital for Sick Children
- Investigators
- Clyde Matava, Principal investigator, Anesthesiologist-in-Cheif
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03929315
- Sponsor's protocol ID
- 1000057104
- Status last verified
- Apr 2023
- First submitted
- 15 Apr 2019
- Last updated
- 7 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomised Control Trial of Competency Metrics and Educational Interventions in the Learning of One Lung Ventilation Techniques in Children Using Low-cost 3D Printed Tracheo-bronchial Models Among Pediatric Anesthesia Trainees
- ClinicalTrials.gov ID
- NCT03929315
- Acronym / sponsor ID
- 1000057104
- Conditions
- Anesthesia
- Keywords
- one lung ventilation
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: COVID made it difficult to access the materials and participants required for this study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Clyde MatavaUniversity, hospital or other
- Study start
- 5 Apr 2023 (actual)
- Primary completion
- 5 Apr 2023 (actual)
- Study completion
- 5 Apr 2023 (actual)
- First posted
- 26 Apr 2019 (actual)
- 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.
One lung ventilation (OLV) in neonates and children is an advanced skill that is necessary for delivery of safe and quality anesthetic care. The current model of training for OLV in the paediatric patient is composed of the apprenticeship model. Trainees learn the techniques of doing the procedure when they encounter a case that allows for it. The model of training is often inadequate for mastery of skills such as OLV as children in this population often have severe debilitating disease often requiring the most experienced anesthesiologist to perform OLV. This limits the training exposure of anesthesia trainees.
Detailed description
Each participant will be subjected to three learning sessions on a 6 year old tracheo-bronchial model. Learning will either be spaced (1 week between learning/testing sessions) or non-spaced (30 minutes between learning/testing sessions). They will have 20 minutes to practice on this model before they are asked to perform the OLV on a younger tracheo-bronchial model (2 yrs, 3 months, 6 weeks). After each testing session, the participants will be provided with feedback. After all learning/testing sessions take place, the participants will be asked to complete a retention test on the 6 week old model six weeks after their last session.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-spaced learning | – | Behavioral: OLV technique on tracheo-bronchial modelLearning/testing sessions will take place within 30 minutes of one another |
| Spaced learning | – | Behavioral: OLV technique on tracheo-bronchial modelLearning/testing sessions will take place 1 week after one another |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- pediatric anesthesia trainees at the Hospital for Sick Children, Toronto
Key inclusion criteria (1 listed)
- Pediatric residents and fellows from the Hospital for Sick Children, Toronto
Key exclusion criteria (3 listed)
- Refusal to participate in study
- Previous experience with at most two OLV in children
- Previous experience with at most two OLV in manikins
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 |
|---|---|---|
| OLV technique on tracheo-bronchial modelModels will range in size from 6 yrs to 6 weeks. | Behavioural | Non-spaced learning, Spaced learning |
Primary outcome
Time
Time frame: Day 1, after each learning session
Seconds it took for correct placement of OLV
Time
Time frame: Week 6 or 9
Seconds in took for correct placement of OLV
8 secondary outcomes
Attempts
Time frame: Week 6 or 9
Wrong entry
Time frame: Week 6 or 9
Red-outs
Time frame: Week 6 or 9
Wall collisions
Time frame: Week 6 or 9
Qualitative endoscopic assessment
Time frame: Week 6 or 9
Overall rating of performance
Time frame: Week 6 or 9
Satisfaction with task load
Time frame: Day 1 or Weeks 1-3
Satisfaction with usability
Time frame: Day 1 or Weeks 1-3
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2023.
- Individual participant dataSharing planned: No
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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.
Clyde Matava principal investigator
Anesthesiologist-in-Cheif
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 Anesthesia, run by Clyde Matava 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 1 inclusion and 3 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: withdrawn, as of the sponsor's last update on 7 Apr 2023. 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 was withdrawn before enrolling participants, so there are no results.
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?
Time (time frame: Day 1, after each learning session). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Apr 2023.