Status:
RECRUITING
Custom Non-invasive Ventilation Masks in Children
Lead Sponsor:
University of Alberta
Collaborating Sponsors:
Stollery Children's Hospital
Conditions:
Noninvasive Ventilation
Child, Only
Eligibility:
All Genders
8-12 years
Phase:
NA
Brief Summary
One significant challenge to non-invasive ventilation (NIV) use in children is finding masks to fit a wide range of growing shapes and sizes. While the technology has improved with development of mask...
Detailed Description
1. Background 1.1 Investigational Device Custom non-invasive ventilation (NIV) masks will be fabricated based on a facial scan of the participant using sterophotogrammetry (3D photography). The scanne...
Eligibility Criteria
Inclusion
- Children between 8-12 years of age
- Followed clinically by the Non-invasive ventilation clinic at the Stollery Children's Hospital
- Established on non-invasive ventilation as part of their treatment plan.
Exclusion
- Children with developmental or physical disabilities that would prevent their successful completion of the study protocol (e.g., non-verbal, unable to follow 3-step commands, unalbe to lie still for 20 min).
- Children whose parent/guardian are unable to provide consent because of an inability to read the study documents in english.
Key Trial Info
Start Date :
December 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT05336136
Start Date
December 15 2023
End Date
September 1 2026
Last Update
January 8 2025
Active Locations (1)
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1
University of Alberta
Edmonton, Alberta, Canada, T6G2R3