NCT03929315

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 15, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 26, 2019

Completed
3.9 years until next milestone

Study Start

First participant enrolled

April 5, 2023

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 5, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 5, 2023

Completed
Last Updated

April 7, 2023

Status Verified

April 1, 2023

Enrollment Period

Same day

First QC Date

April 15, 2019

Last Update Submit

April 5, 2023

Conditions

Anesthesia

Keywords

one lung ventilation

Outcome Measures

Primary Outcomes (2)

  • Time

    Seconds it took for correct placement of OLV

    Day 1, after each learning session

  • Time

    Seconds in took for correct placement of OLV

    Week 6 or 9

Secondary Outcomes (8)

  • Attempts

    Week 6 or 9

  • Wrong entry

    Week 6 or 9

  • Red-outs

    Week 6 or 9

  • Wall collisions

    Week 6 or 9

  • Qualitative endoscopic assessment

    Week 6 or 9

  • +3 more secondary outcomes

Study Arms (2)

Non-spaced learning

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

Behavioral: OLV technique on tracheo-bronchial model

Spaced learning

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

Behavioral: OLV technique on tracheo-bronchial model

Interventions

OLV technique on tracheo-bronchial modelBEHAVIORAL

Models will range in size from 6 yrs to 6 weeks.

Non-spaced learningSpaced learning

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

pediatric anesthesia trainees at the Hospital for Sick Children, Toronto

You may qualify if:

  • Pediatric residents and fellows from the Hospital for Sick Children, Toronto

You may not qualify if:

  • Refusal to participate in study
  • Previous experience with at most two OLV in children
  • Previous experience with at most two OLV in manikins

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Study Officials

  • Clyde Matava

    Anesthesiologist-in-Cheif

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Anesthesiologist

Study Record Dates

First Submitted

April 15, 2019

First Posted

April 26, 2019

Study Start

April 5, 2023

Primary Completion

April 5, 2023

Study Completion

April 5, 2023

Last Updated

April 7, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)