Led by Reed, this research programme investigated the possibility of developing a customisable product for children requiring non-invasive ventilation (NIV).

Non-invasive ventilation (NIV) is the delivery of breathing support via a facemask. Mass-produced masks are available for the adult market but in children it is often difficult to find one that provides an adequate seal necessary to deliver effective treatment. The consequences of poorly fitting masks are severe: at best this can result in pressure sores and impairment of facial bone growth, at worst the outcome is respiratory failure and premature death. In spite of these serious consequences, to date primary research has been unable to find cost effective solutions meeting stringent health service requirements and acceptability to children and their families. This enquiry brought together a multi-stakeholder group with representation from families of children requiring ventilation, clinicians, consultants from Sheffield Children’s hospital and industry. As testing propositions on end users was not ethically possible the development of rigs and protocols became paramount and developed concurrently through the research.

The outcome of the research uses a combination of parts that are both standardised and bespoke. Soft and biocompatible materials, from the mass manufacture industry, are used in conjunction with the harder biocompatible 3D printed customised components. The novelty of the work was in how these parts work and fit together to produce a mask with a good, reduced leak fit that are comparatively cost-effective. This research was funded by NIHR I4I.