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Search / Trial NCT05336136

Custom Non-invasive Ventilation Masks in Children

Launched by UNIVERSITY OF ALBERTA · Apr 12, 2022

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is looking at how custom-made masks for non-invasive ventilation (NIV) can help children breathe better. NIV is a treatment that helps children who have trouble breathing without the need for surgery. A big challenge with NIV is finding masks that fit children properly, as their faces can vary greatly in size and shape. This study aims to create personalized masks using a special scanning technology that captures the shape of a child's face, which may improve comfort and effectiveness of the treatment.

To be eligible for this study, children aged 8 to 12 who are already using NIV as part of their treatment at the Stollery Children's Hospital may participate. Participants will go through a simple process that includes a facial scan, testing the comfort of their current mask versus the custom one, and filling out surveys about how the masks feel. Both the child and their parent or guardian will have a say in which mask they prefer. This trial is currently recruiting participants, so if you think your child might benefit, it could be a great opportunity to explore a better solution for their breathing needs.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 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 Criteria:
  • 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.

About University Of Alberta

The University of Alberta, a leading research institution in Canada, is dedicated to advancing healthcare through innovative clinical trials. With a strong commitment to scientific excellence and community health, the university facilitates cutting-edge research across various medical disciplines. Its interdisciplinary approach fosters collaboration among researchers, clinicians, and students, ensuring that clinical trials are designed and conducted with the utmost rigor and ethical standards. By leveraging its extensive resources and expertise, the University of Alberta aims to translate research findings into meaningful advancements in patient care and public health.

Locations

Edmonton, Alberta, Canada

Patients applied

0 patients applied

Trial Officials

Joanna E MacLean, MD, PhD

Principal Investigator

University of Alberta

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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