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Withdrawn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

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

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.

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