3D OLV Training Intervention for Pediatric Anesthesia Trainees

Anesthesia Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03929315
• Other study ID #: 1000057104
• Status: Withdrawn
• Start date: April 5, 2023
• Est. completion date: April 5, 2023

Study information

• Verified date: April 2023
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 5, 2023
• Est. primary completion date: April 5, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia

Intervention

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

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Clyde Matava

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time	Seconds it took for correct placement of OLV	Day 1, after each learning session
Primary	Time	Seconds in took for correct placement of OLV	Week 6 or 9
Secondary	Attempts	Number of attempts per procedure	Week 6 or 9
Secondary	Wrong entry	Number of entries into wrong bronchus	Week 6 or 9
Secondary	Red-outs	Number of red-outs	Week 6 or 9
Secondary	Wall collisions	Number of wall collisions	Week 6 or 9
Secondary	Qualitative endoscopic assessment	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
Secondary	Overall rating of performance	Measured using Visual Analogue Scale, on a scale of 0-100 where 0=novice and 100=expert	Week 6 or 9
Secondary	Satisfaction with task load	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
Secondary	Satisfaction with usability	Measured using System Usability Scale, on a scale of 5-50	Day 1 or Weeks 1-3