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.
Funder: Department of Health and Social Care

Abstract: Patient/parent focus groups and a survey sent to individuals involved in the care of children requiring non-invasive ventilation (NIV) indicated a need for improved NIV interfaces. Preliminary work has demonstrated that NIV interfaces for children can be designed to fit better and perform more effectively using a bespoke fabrication approach. The proposed project will consider three main approaches: a fully bespoke production approach (option A), a new &ldquo;standard&rdquo; interface (sized and shaped suitably for paediatric patients - Option B) and a hybrid approach of A and B (option C). Option C would combine a standard component designed to receive a bespoke facial contact interface. Workpackages and objectives (bulletpoints) to be delivered during the project are shown below while milestones and project stage gates are detailed within the attached GANTT chart. WP1 Project management Ensure that the project delivers its milestones to time and budget. WP2 NHS and University Ethics Ensure that all research will be conducted ethically and with appropriate approvals. WP3 Pre-development Work WP3.1 Patient and Public Involvement Ensure that the project delivers a NIV interface that meets the needs of patients, their parents and informal carers. WP3.2 Technical analysis of existing products Review of the limitations of current interfaces to further inform the design specification of and confirm the clinical outcome measures for the new interface. WP3.3 Development of clinical assessment tool to identify patients at risk of poor interface fit. Development of a simple tool suitable for ward use to improve NIV mask selection. WP4 Facial Anthropomorphics Understanding of the key anthropomorphic landmarks, shapes and size ranges of paediatric faces to inform the design specification of the new interface. WP5 Regulatory requirements Ensuring that prototype interfaces will be produced applying all appropriate regulatory requirements and with a clear commercialisation strategy. WP6 Design and Development 6.1. Standardised facial mannequin as in-vitro interface test &ldquo;face&rdquo; 6.2. Finalisation of key outcome measures 6.3: Development of a non-contact facial measurement system suitable for scanning paediatric faces free from artefacts in a hospital or home environment. 6.4. Determination of data processing options to translate facial scans into formats suitable for integration into standard 3-D CAD designs systems 6.5. Identification of biocompatible materials and production of first interface prototypes. 6.6: Formation of a CAD digital library of current and new NIV interfaces WP7 Evaluation Testing on adult volunteers to evaluate noise reduction due to minimisation of air leaks, perceived pressure distribution (comfort), and; qualitative review in patient/parent focus groups WP8 Iterative design modifications Product and system design specification will be updated based on learning from preceding work packages. WP9 Patient evaluation Evaluation of the degree to which new interfaces provide clinical and patient benefits using outcome measures determined in WP6.2. WP10 Design for manufacture Ensure that the ultimate route for fully regulated production versions of devices is feasible and viable using the current resources of the industry collaborators. WP11 Commercialisation Identify as wide a variety of means of delivering the technology as possible by assessing the business implications of the alternative manufacturing options. This will encompass processes to assess patients, manufacture products and deliver final results reliably and in compliance with appropriate regulations to international customers.

Lay abstract: 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 &pound;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. These problems lead to an increased burden on nursing and hospital resources as well as harm and suffering to patients. The need for ventilation in these children is often life-long and inability to ventilate the child eventually leads to respiratory failure and premature death. 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 already taken into consideration the opinions and suggestions of patients and parents of children that use NIV in our project design by holding focus groups and their involvement will continue throughout the project. One parent will be a member of the project team. Effective links with industry are central to this project. We have engaged with both a large global (Phillips Respironics) and a UK based (B&D Electromedical) manufacturer of NIV devices, both of whom are enthusiastic in their support for the project. Materialise, who make 3D scanning systems and 3D printing technology, have joined the project team. Together these businesses can provide experience of the practicalities of the ventilation business and of the materials, manufacturing and regulatory challenges involved in the project. The project expects to investigate potential business models to identify the most commercially viable and clinically practical approach applicable to a national/international market. The results should also be transferable to adult medicine, whereby the potential commercial impact and savings to the NHS will be substantial.

Research activity codes: 5.3 MEDICAL DEVICES
Health categories: RESPIRATORY