The Impact of Respiratory Masks on Skin Health

1. “No Pressure!” The impact of respiratory masks on skin health Prof Heather Elphick Consultant in Paediatric Respiratory Medicine Sheffield Children’s Hospital

2. Long term Respiratory Therapy

3. Clinical Need for Long Term Ventilation (LTV) Neuromuscular conditions Airway conditions Craniofacial anomalies

5. Facial pressure ulcers amongst children on long term Non-invasive Ventilation: Incidence and Management StrategiesRendle G, Grychtol R, Robinson V, Chan EYGOSH-to-Home Long Term Ventilation Unit, Respiratory DepartmentGreat Ormond Street Hospital for Children NHS Foundation Trust, UK • Patients treated at GOSH on NIV between 2012-2016 • European Pressure Ulcer Advisory Panel (EPUAP) guidelines were used to grade PU3 (Figure 1). NIV clinical nurse specialists, ward nurses and the tissue viability team were responsible for grading PU. • 14-21 cases per year (4.4%-7.8%) • 22% of all PU occurred in the first 90 days of using NIV 87 out of 601 patients had PU (14%)

6. Conditions associated with pressure sores

8. Location of pressure sores in the Neuromuscular group

9. The offending masks in the Neuromuscular patients!

10. Paediatric literature A cross-sectional retrospective study in a tertiary paediatric hospital with a similar cohort of patients found skin injuries in 19/40 (44%) Fauroux B, et al Intensive Care Med 2005;31(7):965969. A prospective observational study of 989 neonates found 42% had skin injury associated with NIV masks Fischer C,et al. Arch Dis Child Fetal Neonatal Ed 2010;95(6): F447-F451.

11. Risk factors for pressure sores in children immature skin, compromised perfusion, decreased mobility, altered neurological responsiveness, fluid retention, moisture loss, use of steroids presence of medical devices.

12. The Pressure Cycle “The mask becomes dislodged approx. every 2 hours most nights leading to Dad having to get up repeatedly to put it back on.”

13. 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. II-LB-0814-20004

14. Strong Clinical & PPI underpinning of need for improved interfaces PPI Feedback • Focus group • (7 parents, 1 teenage user) • Charity-led Patient / Parent On-line Survey • (33 parent responses in 48 hours) Clinical Feedback • Focus group MDT of paediatric clinicians • (n=5) • On-line survey of clinicians / HCPs • (n=46, 70% adult, 30% paediatric) Most significant ranked as: Pressure Sores Sleep quality (child & family) Comfort Reduced family stress / parental anxiety

15. QUOTES: “I would feel less guilty about making him wear something which hurts his skin. I would get more undisturbed sleep with less leaks/hose dramas. Which in turn might help me to be able to reduce my anti-anxiety meds.” “It would be amazing if we could have the chance of a made-to-measure mask. The main thing it would do is give “J” comfort and in doing that improve her sleep giving her a better quality of life, something we all strive for.”

16. BACKGROUND WORK: PROOF OF CONCEPT Custom interface achieves better seal than standard interface with 19% lower total facial loads forsame strap tension Custom interface Standard interface Facial loads Facial loads Strap load (g) Strap load (g) Load test results Zero reading @800g applied strap load indicates no contact i.e. leak

17. Visscher et al Visscher MO, White C, Jones JM, Cahill, T, Jones DC, Pan BS. Face masks for noninvasive ventilation: fit, excess skin hydration, and pressure ulcers. Respir Care 2015:60(11):1536-1547. high-resolution colour photography to visualize the sub-epidermal microvasculature 3-dimensional surface imaging Skin hydration was measured at mask contact points at the nose bridge, upper and lower left and right cheeks, and chin immediately after removal and before moisture evaporation

18. Visscher et al Skin compromise of varying severity was observed in 72% of subjects Areas of high mask contact higher for the oronasal versus nasal mask more frequent and more severe skin compromise than previous reports (craniofacial disorders in 67%) More than half of the tissue injuries were in areas overlying bone (ie, nose bridge, forehead, and chin)

19. Visscher et al • Pressure ulcers arising from NIV interfaces: • mechanical stress combined with skin occlusion. • non-breathable materials, such as plastic. • Occlusion blocks normal transepidermal water loss. • Over time, increased moisture can cause maceration and increased permeability to exogenous agents. • Moist skin has a higher coefficient of friction, Skin with excess moisture is associated with more frequent and more severe ulcers

20. Remaining challenges Develop better methods of fit Measurement of skin pressure during mask wear Biomarkers/other measures vs discomfort to assess impact on tolerance Incorporate measurements that take into account tissue flexibility and deformability Development of interface that reduces skin damage

22. NIHR Children and Young People MedTech Co-operative (short name: NIHR CYP MedTech Cooperative) The NIHR MICs will build expertise and capacity in the NHS to develop new medical technologies and provide evidence on commercially-supplied in vitro diagnostic (IVD) tests. Funding will be provided over five years for leading NHS organisations to act as centres of expertise; bringing together patients, clinicians, researchers, commissioners and industry. The NIHR MICs will launch 1 January 2018 replacing the NIHR Healthcare Technology Co-operatives and NIHR Diagnostic Evidence Co-operatives, incorporating and retaining the remits of both.

23. NIHR Children and Young People MedTech Co-operative (short name: NIHR CYP MedTech Cooperative) • the selection criteria were: • Evidence that the proposed Clinical Area(s) or Theme(s) has/have the following characteristics: • i) a high burden of disease and unmet need • ii) that the proposed work programme of the Co-operative has the potential to lead to improvements in quality of life of NHS patients, and healthcare services. • The track-record in conducting high quality multidisciplinary research in areas relevant to the proposal • The track-record of developing new medical devices, healthcare technologies and technology-dependent interventions and/or generating evidence of clinical validity, utility cost effectiveness and care pathway benefits, including evidence on demonstrable ‘real life’ applicability, for commercially-supplied IVDs • The strength of the strategic plan • The strength of strategic partnerships including those with other NIHR-funded research infrastructure, industry, charities, other health sectors, and other health and care providers and organisations • Value for money

24. NIHR CYP MedTech Cooperative (CYP-TECH) NIHR MedTech and In Vitro Diagnostic Co-operatives (MICs) are 11 centres based in the NHS to provide expertise in the development of medical technologies (MedTech) and/or the evidencing for in vitro diagnostics (IVDs). NIHR Medtech Co-operatives focus on catalysing the development of new medical and healthcare technologies that will be applicable across the NHS.

25. CYP-TECH • 7 themes across different centres of expertises • Rare Diseases - Birmingham (Rare Diseases Centre) • Resp & Sleep – Sheffield Children’s Hospital • Paediatric Surgical Technologies - Alder Hey • Ventilation – Evelina • Paediatric Oncology – Newcastle • Epilepsy, Movement and Muscle Disorders – GOSH • Transition - Birmingham • Links with other MICS to support paediatric technologies. We plan to hold a meeting once a year to bring all the MICS together to report on paediatric technology development • Support from the TITCH Network • CYP-TECH will provide support in all areas of the innovation pipeline in terms of technology development