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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03929315
Other study ID # 1000057104
Secondary ID
Status Withdrawn
Phase
First received
Last updated
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
Health authority
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Status Withdrawn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

Study Design


Related Conditions & MeSH terms


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
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