Publications

Publications

 

Title

Feasibility and acceptability of a novel forehead-mounted wireless heart rate monitoring device in preterm babies

Abstract

Myhill J 1 , Pocock L 1 , Clarke P 1,2

1 Norfolk and Norwich University Hospitals NHS Foundation Trust, Norwich, Norfolk, United Kingdom

2 Norwich Medical School, University of East Anglia, Norwich, Norfolk, United Kingdom

 Background: Up to 10% of newborns require enhanced support or resuscitation at birth. Optimal management immediately after birth is critical to improve outcomes. While heart rate (HR) readily indicates response to interventions, HR monitoring via auscultation, umbilical cord palpation, ECG and pulse oximetry all have limitations in the delivery room (DR). We aimed to evaluate the feasibility and acceptability of using a novel wireless HR monitor in preterm infants in the DR and NICU.

Methods: The SurePulse VS (SurePulse Medical Ltd, Nottingham, UK) comprises a single-use thermoprotective Cap with an integrated optical sensor which, wirelessly via a module, transmits real-time pulse waveform to a display.(Figure) We undertook a prospective, observational evaluation of this device in preterm infants in our centre’s NICU and DR over a 4-month period. We used structured questionnaires to gather immediate staff feedback on the functionality and acceptability of the device for HR monitoring. We compared real-time recorded HR data post hoc with staff perceived utility of the SurePulse VS device.

Results: 31 babies underwent monitoring (10 NICU, 15 Theatre, 6 DR). Two with zero recorded data were excluded (device start button was not activated). Median (range) gestational age was 31+5 (24+6 to 36+6) weeks and birthweight 1715 (420 to 3055) grammes. 50 user questionnaires were completed. Questionnaire reported results: i) Ease of Cap fitting (86% easy or very easy); ii) HR signal reliability (86% all or most of the time); iii) HR acquisition time (48% <30 s, 72% <90 s, remaining 28% ≥120 s). In 1/29 babies a usable HR recording was not obtainable. Recorded data supported user questionnaire feedback (25/29 babies on reported acquisition time; 26/29 babies on reported reliability). When non-invasive respiratory equipment was deployed (n=9), 100% staff reported ‘easy’/‘very easy’ CPAP integration with the Cap.

Conclusion: This relatively new HR monitoring approach demonstrated feasibility for use in preterm babies in our tertiary-level centre, and good staff user acceptability. Wireless HR monitoring has the potential for assisting safe and effective monitoring by staff, while allowing parents greater autonomy during first cuddles with their babies in the DR, and during skin-to-skin/kangaroo care in the NICU.

Publication

Title

Accurate neonatal heart rate monitoring using a new wireless, cap mounted device

Abstract

Henry, C, Shipley, L, Ward, C, et al.

Acta Paediatr. 2020; 00: 1– 7.

Aim: A device for newborn heart rate (HR) monitoring at birth that is compatible with delayed cord clamping and minimises hypothermia risk could have advantages over current approaches. We evaluated a wireless, cap mounted device (fhPPG) for monitoring neonatal HR.

Methods: A total of 52 infants on the neonatal intensive care unit (NICU) and immediately following birth by elective caesarean section (ECS) were recruited. HR was monitored by electrocardiogram (ECG), pulse oximetry (PO) and the fhPPG device. Success rate, accuracy and time to output HR were compared with ECG as the gold standard. Standardised simulated data assessed the fhPPG algorithm accuracy.

Results: Compared to ECG HR, the median bias (and 95% limits of agreement) for the NICU was fhPPG −0.6 (−5.6, 4.9) vs PO −0.3 (−6.3, 6.2) bpm, and ECS phase fhPPG −0.5 (−8.7, 7.7) vs PO −0.1 (−7.6, 7.1) bpm. In both settings, fhPPG and PO correlated with paired ECG HRs (both R2 = 0.89). The fhPPG HR algorithm during simulations demonstrated a near‐linear correlation (n = 1266, R2 = 0.99).

Conclusion: Monitoring infants in the NICU and following ECS using a wireless, cap mounted device provides accurate HR measurements. This alternative approach could confer advantages compared with current methods of HR assessment and warrants further evaluation at birth.

Link

Title

Development of a Clinical Interface for a Novel Newborn Resuscitation Device: Human Factors Approach to Understanding Cognitive User Requirements

Abstract

Pickup L, Lang A, Shipley L, Henry C, Carpenter J, McCartney D, Butler M, Hayes-Gill B, Sharkey D

JMIR Hum Factors 2019;6(2):e12055

Background: A novel medical device has been developed to address an unmet need of standardizing and facilitating heart rate recording during neonatal resuscitation. In a time-critical emergency resuscitation, where failure can mean death of an infant, it is vital that clinicians are provided with information in a timely, precise, and clear manner to capacitate appropriate decision making. This new technology provides a hands-free, wireless heart rate monitoring solution that easily fits the clinical pathway and procedure for neonatal resuscitation.

Objective: This study aimed to understand the requirements of the interface design for a new device by using a human factors approach. This approach combined a traditional user-centered design approach with an applied cognitive task analysis to understand the tasks involved, the cognitive requirements, and the potential for error during a neonatal resuscitation scenario.

Methods: Fourteen clinical staff were involved in producing the final design requirements. Two pediatric doctors supported the development of a visual representation of the activities associated with neonatal resuscitation. This design was used to develop a scenario-based workshop. Two workshops were carried out in parallel and involved three pediatric doctors, three neonatal nurses, two advance neonatal practitioners, and four midwives. Both groups came together at the end to reflect on the findings from the separate sessions.

Results: The outputs of this study have provided a comprehensive description of information requirements during neonatal resuscitation and enabled product developers to understand the preferred requirements of the user interface design for the device. The study raised three key areas for the designers to consider, which had not previously been highlighted: (1) interface layout and information priority, as heart rate should be central and occupy two-thirds of the screen; (2) size and portability, to enable positioning of the product local to the baby’s head and allow visibility from all angles; and (3) auditory feedback, to support visual information on heart rate rhythm and reliability of the trace with an early alert for intervention while avoiding parental distress.

Conclusions: This study demonstrates the application of human factors and the applied cognitive task analysis method, which identified previously unidentified user requirements. This methodology provides a useful approach to aid development of the clinical interface for medical devices.

Link

Title

Forehead reflectance photoplethysmography to monitor heart rate: preliminary results from neonatal patients

Abstract

M R Grubb1, J Carpenter1, J A Crowe1, J Teoh1, N Marlow2, C Ward3, C Mann3, D Sharkey3 and B R Hayes-Gill1

Physiological Measurement, Volume 35, Number 5

Around 5%–10% of newborn babies require some form of resuscitation at birth and heart rate (HR) is the best guide of efficacy. We report the development and first trial of a device that continuously monitors neonatal HR, with a view to deployment in the delivery room to guide newborn resuscitation. The device uses forehead reflectance photoplethysmography (PPG) with modulated light and lock-in detection. Forehead fixation has numerous advantages including ease of sensor placement, whilst perfusion at the forehead is better maintained in comparison to the extremities. Green light (525 nm) was used, in preference to the more usual red or infrared wavelengths, to optimize the amplitude of the pulsatile signal. Experimental results are presented showing simultaneous PPG and electrocardiogram (ECG) HRs from babies (n = 77), gestational age 26–42 weeks, on a neonatal intensive care unit. In babies ≥32 weeks gestation, the median reliability was 97.7% at ±10 bpm and the limits of agreement (LOA) between PPG and ECG were +8.39 bpm and −8.39 bpm. In babies <32 weeks gestation, the median reliability was 94.8% at ±10 bpm and the LOA were +11.53 bpm and −12.01 bpm. Clinical evaluation during newborn deliveries is now underway.

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Dr. James Carpenter

CEO

James Carpenter has served as CEO of SurePulse Medical since its incorporation in mid-2014, having worked to secure considerable grant funding for early development and trials. He has spent 7 years working in medical device engineering and development, particularly focussed on blood flow analysis in the field of Laser Doppler Blood Flowmetry. More recently his work has been centred on high-reliability heart rate estimation. He holds a PhD in Electronic Engineering from the University of Nottingham.

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Warwick Adams

Non-Executive Director

Warwick Adams has 30 years of experience in the design and manufacture of electronic equipment both in the commercial and medical arena. He started in electronics within the Medical Physics department at the Queens Medical Centre Nottingham and then formed his own business in 1982 designing and manufacturing medical and commercial electronics and systems. Warwick has founded a number of businesses and holds a board position in many of these companies a number of which are certified to ISO 13485. Warwick has also been involved in a number of successful applications and grants for Innovate UK projects with Nottingham University.

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Bill Allan

Chairman

Bill has a strong international track-record of focussed, profitable sales growth and of developing high performance teams through small and large scale organisational development. For the past 10 years, Bill has led and transitioned 2 small Medical Device companies to sale and integration, and is a non-executive Board Member for a number of Medical Technology companies.

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Matthew Butler

Electronics Engineer

Matthew Butler is an experienced electronics and software engineer. He has designed electronics solutions for international companies, and is bewilderingly fluent in a variety of software languages. He holds a PhD degree in electronic engineering.

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Prof. Barrie Hayes-Gill

Research Director

Professor Barrie Hayes-Gill has over 30 years of expertise in medical electronic devices and has considerable experience of taking devices into the clinic including co-founding Monica Healthcare Ltd that has fully commercialised a fetal heart rate monitor. He has taken several devices through regulatory approvals in the EU (CE) and USA (FDA). He has managed and delivered a number of projects that have underpinned SurePulse's development.

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Quentin Hayes

Commercial Manager

Quentin has over 25 years’ experience in pharmaceuticals, medical devices and healthcare services in the private sector and the NHS. His leadership roles include Sales, Marketing, Market Access, Clinical Research, Governance, Operational and Executive Management. He has Project Leadership expertise in Change Management, Business/Process improvement, and Contract Management.

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Yvonne Hooton

Clinical Specialist

Yvonne is our Clinical Specialist who has worked at Nottingham University Hospitals NHS Trust for 30 years, she is a Registered General Nurse/Registered Sick Children's Nurse with a BSC in Health Studies. She has extensive experience in Neonatal care having worked as a Neonatal Sister, Advanced Neonatal Nurse Practitioner and Children's Clinical Research Nurse working on obstetric, paediatric and neonatal studies.

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Russell Hoyle

Non-Executive Director

Russell Hoyle runs an independent business consultancy advising small and medium sized companies on their strategic development opportunities. As well as being a Non-Executive Director of SurePulse Medical Ltd, he is a Special Partner with private equity firm Vitruvian Partners LLP, and Chairman of UK based electronics manufacturer Tioga Ltd. He is a Board member of the Responsible Gambling Strategy Board, which advises Government and Regulators on policy in relation to research, education and treatment for problem gamblers. Until mid-2010, he was Chairman of Inspired Gaming Group plc, an AIM listed technology provider to the land based gaming market.

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Dr Damon McCartney

Principal Engineer

Dr Damon McCartney is an experienced product development manager, and is responsible for all engineering aspects of the company’s products. He has spent several years working in start-ups in a variety of industries. He holds a PhD in electronic engineering.

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Dr Son Nguyen

Electronics Engineer

Son Nguyen has experience in building products to medical device quality standards (e.g. BS EN 60601-1) having spent a number of years designing skin impedance tracking systems. He graduated with a PhD in electronic engineering from the University of Nottingham in 2016.

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Khoa Pham

Administrator

Khoa Pham is our company administrator and literally holds everything together! She has a number of degrees and experience in administration and book-keeping.

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Catherine Procter

Software Engineer

Catherine is a highly experienced software engineer responsible for developing and testing embedded code for our medical devices. She has held positions in multiple reliability-critical industries. She holds a Masters Degree in Reliable Embedded Systems.

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Dr Don Sharkey

Clinical Director

Dr Don Sharkey is Professor of Neonatal Medicine and Technologies, University of Nottingham, and honorary consultant neonatologist at Nottingham University Hospitals NHS Trust. He has overseen previous published newborn baby trials in both the Neonatal Intensive Care Unit and delivery room.

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Faye Griffin

Product Manager

Faye has over thirteen years’ experience in medical device Product Management, most recently in the wireless vital signs monitoring market. She obtained her marketing qualification through the Chartered Institute of Marketing and Product Management expertise through Pragmatic Marketing programmes.

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