Custom Non-invasive Ventilation Masks in Children

Recruiting now · Not applicable

Conditions studied: Noninvasive Ventilation, Child, Only, Adherence, Patient

In brief

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 masks specifically for children, the range of options remains limited. Given the smaller size relative to adults, craniofacial abnormalities and craniofacial differences are more likely to compromise mask fit for children. A poor mask fit is uncomfortable, alters delivery of airway pressure, and, in some children, leads to failure of NIV and the need for surgical insertion of an airway in the neck to deliver positive airway pressure through a tracheostomy. This makes expanding the technology to deliver NIV vital and custom NIV masks an exciting solution.In this study, this study will enroll children who are established on long-term NIV with at least some use within 3 months of starting this therapy but who have non-optimal adherence. After consenting to participate and completing demographic and health questionnaire, participants will undergo a facial scan using stereophotogrammetry. This scan will be imported into a computer-aided design software to create a NIV mask customized to the individual face. The steps of mask testing will include: i) Bench testing to compare the leak and comfort parameters of the current commercial mask used by the participant to the custom mask: ii) Efficacy of treatment as measured by polysomonography iii) NIV compliance from machine downloads; iv) Questionnaires to assess the subjective comfort, fit, and adverse events Finally, participants and their parents/guardian will be asked which mask they prefer and why.

Key facts

Study ID

NCT05336136

Run by

University of Alberta

People needed

15

Starts

2023-12-15

Expected to finish

2026-06-01

Last updated by the study team

2026-03-16

Who can join

Age: 8 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Alberta — Edmonton, Alberta, Canada (enrolling)

Full record on ClinicalTrials.gov

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