RecruitingNot ApplicableNCT05336136

Custom Non-invasive Ventilation Masks in Children


Sponsor

University of Alberta

Enrollment

15 participants

Start Date

Dec 15, 2023

Study Type

INTERVENTIONAL

Conditions

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 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.


Eligibility

Min Age: 8 YearsMax Age: 12 Years

Plain Language Summary

Simplified for easier understanding

This study tests custom-fitted non-invasive ventilation (NIV) masks made specifically for each child's face to see if they are more comfortable and effective than standard masks. It is designed for children who already use NIV machines (like CPAP or BiPAP) at home. You may be eligible if: - Your child is between 8 and 12 years old - Your child is followed at the Non-invasive Ventilation Clinic at Stollery Children's Hospital - Your child already uses non-invasive ventilation as part of their treatment You may NOT be eligible if: - Your child has developmental or physical disabilities that would prevent completing the study procedures - Your child's parent or guardian cannot read study documents in English Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICECustom mask

Custom mask based on 3D facial photograph for administration of non-invasive ventilation

DEVICECurrent commercial mask

Current commercial mask used for administration of non-invasive ventilation


Locations(1)

University of Alberta

Edmonton, Alberta, Canada

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NCT05336136


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