- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03929315
3D OLV Training Intervention for Pediatric Anesthesia Trainees
April 5, 2023 updated by: Clyde Matava
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
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 Type
Observational
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5G 1X8
- The Hospital for Sick Children
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
pediatric anesthesia trainees at the Hospital for Sick Children, Toronto
Description
Inclusion Criteria:
- Pediatric residents and fellows from the Hospital for Sick Children, Toronto
Exclusion Criteria:
- Refusal to participate in study
- Previous experience with at most two OLV in children
- Previous experience with at most two OLV in manikins
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Non-spaced learning
Learning/testing sessions will take place within 30 minutes of one another
|
Models will range in size from 6 yrs to 6 weeks.
|
|
Spaced learning
Learning/testing sessions will take place 1 week after one another
|
Models will range in size from 6 yrs to 6 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time
Time Frame: Day 1, after each learning session
|
Seconds it took for correct placement of OLV
|
Day 1, after each learning session
|
|
Time
Time Frame: Week 6 or 9
|
Seconds in took for correct placement of OLV
|
Week 6 or 9
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Attempts
Time Frame: Week 6 or 9
|
Number of attempts per procedure
|
Week 6 or 9
|
|
Wrong entry
Time Frame: Week 6 or 9
|
Number of entries into wrong bronchus
|
Week 6 or 9
|
|
Red-outs
Time Frame: Week 6 or 9
|
Number of red-outs
|
Week 6 or 9
|
|
Wall collisions
Time Frame: Week 6 or 9
|
Number of wall collisions
|
Week 6 or 9
|
|
Qualitative endoscopic assessment
Time Frame: Week 6 or 9
|
Measured using Global Rating Scale of Fibreoptic Bronchoscope Manipulation, on a scale of 4-20, where 4=novice and 20=expert
|
Week 6 or 9
|
|
Overall rating of performance
Time Frame: Week 6 or 9
|
Measured using Visual Analogue Scale, on a scale of 0-100 where 0=novice and 100=expert
|
Week 6 or 9
|
|
Satisfaction with task load
Time Frame: Day 1 or Weeks 1-3
|
Measured using Task Load Index, on a scale of 0-100, where 0=very low and 100=very high
|
Day 1 or Weeks 1-3
|
|
Satisfaction with usability
Time Frame: Day 1 or Weeks 1-3
|
Measured using System Usability Scale, on a scale of 5-50
|
Day 1 or Weeks 1-3
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 5, 2023
Primary Completion (Actual)
April 5, 2023
Study Completion (Actual)
April 5, 2023
Study Registration Dates
First Submitted
April 15, 2019
First Submitted That Met QC Criteria
April 25, 2019
First Posted (Actual)
April 26, 2019
Study Record Updates
Last Update Posted (Actual)
April 7, 2023
Last Update Submitted That Met QC Criteria
April 5, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 1000057104
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Anesthesia
-
Samsun UniversityCompletedAnesthesia | Regional Anesthesia | Anesthesia ManagementTurkey
-
Charite University, Berlin, GermanyCompletedAnesthesia, Local | Anesthesia | Anesthesia; Adverse EffectGermany
-
Hospital de Clinicas José de San MartínMedtronicNot yet recruitingPediatric Anesthesia | Anesthesia | Total Intravenous AnesthesiaArgentina
-
Novocol Pharmaceutical of Canada, Inc.CompletedAnesthesia, Local | Dental Anesthesia | Anesthesia, ReversalUnited States
-
Universitas Sebelas MaretIndonesia Endowment Fund for EducationNot yet recruitingAnesthesia | Anesthesia; Reaction
-
University Health Network, TorontoActive, not recruiting
-
University of PecsCompleted
-
Hormozgan University of Medical SciencesUnknownAnesthesia | Anesthesia; FunctionalIran, Islamic Republic of
-
Ankara City Hospital BilkentCompletedAnesthesia | Sedation | Anesthesia, Intravenous | Sedation Complication | Recovery From Anesthesia | Monitoring of Depth of AnesthesiaTurkey (Türkiye)
-
Aligarh Muslim UniversityCompletedAnesthesia | Anesthesia Intubation Complication | Anesthesia; Adverse EffectIndia
Clinical Trials on OLV technique on tracheo-bronchial model
-
Aslı MemisCompletedAdolescent | Behavior, Addictive | Motivation | Digital TechnologyTurkey