About Bolder Science

Our mission is to provide healthcare professionals with unbiased clinical research information, easily.

Currently, you can access the following clinical trials being conducted worldwide:

378040 studies
in
220 countries
Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.
This website is for US healthcare professionals

Log In to Bolder Science

or

Don't have an account? Sign Up

Please enter your email address.

You will receive a link to create a new password via email.

Log In

Create an Account

or
(optional) ?

Welcome, !

Please complete the following 4 questions to ensure you receive the information that best suits your needs.

Clinical Trials of Interest

When I’m looking for information on clinical trials, I usually am interested in...

finding clinical trials in which to enroll my patients

Rarely Often

finding newly launched clinical trials (for all phases)

Rarely Often

updates on status changes for clinical trials

Rarely Often

pipeline molecules

Rarely Often

Drug Interventions

Enter up to 3 drug interventions you are currently interested in:

Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.

3D OLV Training Intervention for Pediatric Anesthesia Trainees

Clinicaltrials.gov identifier NCT03929315

Recruitment Status Not yet recruiting

First Posted April 26, 2019

Last update posted February 2, 2021

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:Anesthesia
  • Intervention/Treatment: Behavioral: OLV technique on tracheo-bronchial model
  • Phase: N/A
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
  • Estimated 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
  • Estimated Study Start Date: March 2021
  • Estimated Primary Completion Date: August 2021
  • Estimated Study Completion Date: December 2021
Groups and Cohorts
Groups/Cohorts 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 [ Time Frame: Day 1, after each learning session ]
    Seconds it took for correct placement of OLV
  • 2. Time [ Time Frame: Week 6 or 9 ]
    Seconds in took for correct placement of OLV
  • Secondary Outcome Measures: 1. Attempts [ Time Frame: Week 6 or 9 ]
    Number of attempts per procedure
  • 2. Wrong entry [ Time Frame: Week 6 or 9 ]
    Number of entries into wrong bronchus
  • 3. Red-outs [ Time Frame: Week 6 or 9 ]
    Number of red-outs
  • 4. Wall collisions [ Time Frame: Week 6 or 9 ]
    Number of wall collisions
  • 5. 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
  • 6. 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
  • 7. 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
  • 8. Satisfaction with usability [ Time Frame: Day 1 or Weeks 1-3 ]
    Measured using System Usability Scale, on a scale of 5-50
Eligibility Criteria
  • Ages Eligible for Study: (Child, Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: Yes
  • Sampling Method: Non-Probability Sample
  • Study Population: pediatric anesthesia trainees at the Hospital for Sick Children, Toronto
Criteria

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
Contacts

Contact: Clyde Matava 416-813-7654 clyde.matava@sickkids.ca

Locations

Canada, Ontario
The Hospital for Sick Children
Toronto

Sponsors and Collaborators

Clyde Matava

Investigators

Principal Investigator: Clyde Matava Anesthesiologist-in-Cheif

More Information
  • Responsible Party: Clyde Matava
  • ClinicalTrials.gov Identifier: NCT03929315 History of Changes
  • Other Study ID Numbers: 1000057104
  • First Posted: April 26, 2019 Key Record Dates
  • Last Update Posted: February 2, 2021
  • Last Verified: January 2021
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • 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: one lung ventilation