3D OLV Training Intervention for Pediatric Anesthesia Trainees

Sponsor
Clyde Matava (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT03929315
Collaborator
(none)
30
1
18
1.7

Study Details

Study Description

Brief 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. 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: OLV technique on tracheo-bronchial model

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

Study Type:
Observational
Anticipated Enrollment :
30 participants
Observational Model:
Cohort
Time Perspective:
Prospective
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
Anticipated Study Start Date :
Jun 1, 2022
Anticipated Primary Completion Date :
May 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Non-spaced learning

Learning/testing sessions will take place within 30 minutes of one another

Behavioral: OLV technique on tracheo-bronchial model
Models will range in size from 6 yrs to 6 weeks.

Spaced learning

Learning/testing sessions will take place 1 week after one another

Behavioral: OLV technique on tracheo-bronchial model
Models will range in size from 6 yrs to 6 weeks.

Outcome Measures

Primary Outcome Measures

  1. Time [Day 1, after each learning session]

    Seconds it took for correct placement of OLV

  2. Time [Week 6 or 9]

    Seconds in took for correct placement of OLV

Secondary Outcome Measures

  1. Attempts [Week 6 or 9]

    Number of attempts per procedure

  2. Wrong entry [Week 6 or 9]

    Number of entries into wrong bronchus

  3. Red-outs [Week 6 or 9]

    Number of red-outs

  4. Wall collisions [Week 6 or 9]

    Number of wall collisions

  5. Qualitative endoscopic assessment [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

  6. Overall rating of performance [Week 6 or 9]

    Measured using Visual Analogue Scale, on a scale of 0-100 where 0=novice and 100=expert

  7. Satisfaction with task load [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

  8. Satisfaction with usability [Day 1 or Weeks 1-3]

    Measured using System Usability Scale, on a scale of 5-50

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 The Hospital for Sick Children Toronto Ontario Canada M5G 1X8

Sponsors and Collaborators

  • Clyde Matava

Investigators

  • Principal Investigator: Clyde Matava, Anesthesiologist-in-Cheif

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Clyde Matava, Anesthesiologist, The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT03929315
Other Study ID Numbers:
  • 1000057104
First Posted:
Apr 26, 2019
Last Update Posted:
Dec 17, 2021
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Clyde Matava, Anesthesiologist, The Hospital for Sick Children

Study Results

No Results Posted as of Dec 17, 2021