Paul Seddon Royal Alexandra Children s Hospital, Brighton. David Wertheim Kingston University
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1 Paul Seddon Royal Alexandra Children s Hospital, Brighton David Wertheim Kingston University
2 Respiratory problems account for almost half the cost of primary healthcare More premature infants are surviving, but many with chronic lung disease needing home oxygen Respiratory rate is a key clinical indicator Component of Paediatric Early Warning Scores Predicts need for hospital admission Current techniques unsatisfactory Visual counting unreliable Other systems: nasal airflow, Respitrace, impedance pneumography) poorly tolerated and may affect breathing Pulse oximetry routinely used for monitoring oxygen dependent and wheezy children
3 Pleth waveform from standard pulse oximeter is complex, and contains Dominant (fast) heart rate waveform (HR) Underlying (slow) resp rate waveform (RR) Signal processing could potentially remove HR and reveal RR
4 Pleth signal displayed by commercial pulse oximeters is heavily processed to reduce artefact approached several companies to request access to raw signal for research Initial positive response... then blocked somewhere high up in company? Commercial secrecy re anti-artifact processing Eventually Nonin agreed to allow us to access raw pleth signal Fruitful working relationship has continued to present.
5 Healthy newborn infants Recorded raw pleth signal and simultaneous airflow from facemask Processed pleth signal to filter out HR wave
6 In healthy newborns, RR from RAO is identical to RR from facemask airflow signal 1 In wheezy preschool children, RR from RAO is identical to RR from visual counting 2 In infants with lung disease undergoing polysomnography 3 : RR from RAO is identical to RR from Respitrace RAO appears to detect central apnoeas 1. ArchDisChild Med Biol Eng Comput Acta Paediatr 2014
7 RAO Chest band Abdo band
8 SaO2 97% HR 120 RR 46
9 Working with Nonin? Large US corporation Good working relationship since 2007 Enthusiasm from technical teams Caution/ambivalence from management/marketing Public funding? Application via i4i stream of NIHR Submitted May 2014 Invited to present to board Nov 2014 Final decision Jan 2015 still waiting. Other options?
10 Objective: Develop app software compatible with tablet/smartphone devices, capable of performing RAO in real time Method: Software development in the lab using stored anonymised signals from 75 infants with a variety of respiratory rates and patterns. Initially develop software for Android and Windows platforms consider ios also
11 Objectives: Evaluate the software in a hospital setting (Special Care Nursery) technical and user feedback Design teaching package for parents in advance of home evaluation Methods: Prospectively study 30 infants with range of sizes and respiratory rates, comparing RAO RR with Respitrace RR, during short then prolonged periods Gain feedback from parents on user interface and home monitoring issues Revise software as needed (WP1) in light of both above Design and evaluate teaching package with help of parent panel
12 Aim: Evaluate the software in a home setting - technical and user feedback Methods: Study 20 infants on home oxygen within 2 months of discharge 50% experienced parents Evaluate quality and accuracy of RR signal obtained Evaluate technical and user aspects of monitor alarms All parents to receive teaching package prior to discharge, with support from the team post-discharge
13 Objective: Develop secure, reliable transmission of data from home to hospital Methods: Explore different options for confidential data transmission via mobile telephone networks, with hierarchy of complexity: Summary data (eg 8 hours -Sat, HR, RR) post-hoc Summary data in real time Full pleth signals in real time Develop and troubleshoot transmission in hospital Asssess transmission from the home, with technical and user feedback (parent and healthcare staff) Determine best option(s) for siting of RAO software: Within pulse oximeter As stand-alone software in tablet or smartphone In healthcare hub, analysing transmitted pleth signals
14 Likely clinical applications Home monitoring of high-risk children and adults Uses existing pulse oximeter sensor Hospital monitoring of children and adults in clinical areas with lower staffing levels Home assessment of obstructive sleep apnoea Commercialisation and Intellectual property Exact market placement will depend whether technology will sit within oximeter as stand-alone app in healthcare hub or all three Marketing envisaged to healthcare organisations not direct to parents/patients, at least initially MHRA application and formal licensing trials
15 We are developing an innovative technology which seeks to address a defined and clear clinical need Our experience illustrates some of the difficulties, but also the rich opportunities, of collaboration between the NHS, Universities and the commercial sector We can each learn and profit from working together, to develop technology that benefits sick infants and children
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