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3D OLV Training Intervention for Pediatric Anesthesia Trainees

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ClinicalTrials.gov Identifier: NCT03929315
Recruitment Status : Enrolling by invitation
First Posted : April 26, 2019
Last Update Posted : April 26, 2019
Sponsor:
Information provided by (Responsible Party):
Clyde Matava, The Hospital for Sick Children

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
Anesthesia 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.

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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 : April 2019
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : December 2019

Group/Cohort 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.




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



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03929315


Locations
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Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Sponsors and Collaborators
Clyde Matava
Investigators
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Principal Investigator: Clyde Matava Anesthesiologist-in-Cheif

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Responsible Party: Clyde Matava, Anesthesiologist, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT03929315     History of Changes
Other Study ID Numbers: 1000057104
First Posted: April 26, 2019    Key Record Dates
Last Update Posted: April 26, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Clyde Matava, The Hospital for Sick Children:
one lung ventilation