Custom-made NIV masks for children - use of imaging data
Research type
Research Study
Full title
Development of customised non-invasive ventilation interfaces for children for whom current commercial masks are unavailable or unsuitable to improve ventilation therapies and reduce complications.
IRAS ID
197849
Contact name
Heather Elphick
Contact email
Sponsor organisation
Sheffield Childrens NHS Foundation Trust
Duration of Study in the UK
2 years, 5 months, 0 days
Research summary
Non-invasive ventilation (NIV) is the delivery of breathing support via a facemask. It is used to treat people whose natural breathing is ineffective. Evidence shows that, when used long-term, it improves both quality of life and life expectancy.
Ventilation is delivered in the home through a mask covering the nose or the nose and mouth. A good fit with a seal between the mask and the patient’s face is essential to deliver the treatment effectively. Mass-produced masks are available for the adult market but in children it is often difficult to find a mask that provides an adequate seal. Two particularly disadvantaged groups are very young infants and children with facial deformities or facial asymmetry. In these groups NIV may not be possible due to unavailability of an adequate mask.
Currently the options for these groups of children are to ventilate invasively via a breathing tube (tracheostomy), to persevere with NIV through an inadequate mask, or to abandon ventilation. Invasive ventilation offers the advantage of a stable airway, but can lead to serious complications and difficulty with speech development, and the cost of the care packages to support these families in Sheffield is in excess of £100K/yr per patient. NIV with an inadequately fitting mask leads to pressure sores, impairment of facial bone growth and significant disturbance to the sleep of the child and family due to noise from air leakage from the mask and alarms from the ventilator.
We propose an innovative use of 3D assessment and manufacturing technologies to deliver novel mask-face interfaces to optimise mask fit to the needs of individual patients. We have demonstrated that our proposed method is more effective than a standard mass-produced mask in the laboratory setting.
We have gained NIHR funding for the project.
REC name
North West - Greater Manchester East Research Ethics Committee
REC reference
16/NW/0241
Date of REC Opinion
30 Mar 2016
REC opinion
Favourable Opinion