Evidence

SurePulse clinical publications

 

Title “Accurate neonatal heart rate monitoring using a new wireless, cap mounted device”
Authors Henry, C.; Shipley, L.; Ward, C.; Mirahmadi, S.; Liu, C.;  Morgan, S.; Crowe, J.; Carpenter, J.; Hayes-Gill, B.; Sharkey, D.
Publication Acta Paediatrica 2020;00:1–7.
Link https://doi.org/10.1111/apa.15303
Abstract 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. 

Title “Development of a Clinical Interface for a Novel Newborn Resuscitation Device: Human Factors Approach to Understanding Cognitive User Requirements”
Authors Pickup L, Lang A, Shipley L, Henry C, Carpenter J, McCartney D, Butler M, Hayes-Gill B, Sharkey D
Publication JMIR Hum Factors 2019; 6(2):e12055
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6592395/
Abstract 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.

Title “Accuracy Of Obtaining Neonatal Heart Rate From A Novel Hat Mounted, Green Wavelength Optical Device”
Authors Henry, C.; Shipley, L.; Ward, C.; Mirahmadi, S.; Hayes-Gill, B.; Carpenter, J.; Mc Cartney, D.; Sharkey, D.
Publication 2nd Congress of joint European Neonatal Societies, Poster, November 2017, Venice
Title “Forehead reflectance photoplethysmography to monitor heart rate: preliminary results from neonatal patients”
Authors Grubb, M. R.; Carpenter, J.; Crowe, J. A and Hayes-Gill B R.
Publication PHYSIOLOGICAL MEASUREMENT Volume:35 Issue:5Pages:881-893 Published: MAY 2014 
Link https://iopscience.iop.org/article/10.1088/0967-3334/35/5/881/meta
Abstract 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.
Title “Marked variation in newborn resuscitation practice: A national survey in the UK”
Authors Mann, C.;  Ward, C.; Grubb, M.; Hayes-Gill, B.; Crowe, J.; Marlow, N.; Sharkey, D.
Publication RESUSCITATION, Vol: 83 Issue: 5 pp: 607-611 January 2012
Link https://www.resuscitationjournal.com/article/S0300-9572(12)00009-3/fulltext
Abstract Background: Although international newborn resuscitation guidance has been in force for some time, there are no UK data on current newborn resuscitation practices.

Objective: Establish delivery room (DR) resuscitation practices in the UK, and identify any differences between neonatal intensive care units (NICU), and other local neonatal services.

Methods: We conducted a structured two-stage survey of DR management, among UK neonatal units during 2009–2010 (n = 192). Differences between NICU services (tertiary level) and other local neonatal services (non-tertiary) were analysed using Fisher’s exact and Student’s t-tests.

Results: There was an 89% response rate (n = 171). More tertiary NICUs institute DR CPAP than non-tertiary units (43% vs. 16%, P = 0.0001) though there was no significant difference in frequency of elective intubation and surfactant administration for preterm babies. More tertiary units commence DR resuscitation in air (62% vs. 29%, P < 0.0001) and fewer in 100% oxygen (11% vs. 41%, P < 0.0001). Resuscitation of preterm babies in particular, commences with air in 56% of tertiary units. Significantly more tertiary units use DR pulse oximeters (58% vs. 29%, P < 0.01) and titrate oxygen based on saturations. Almost all services use occlusive wrapping to maintain temperature for preterm infants.

Conclusions: In the UK, there are many areas of good evidence-based DR practice. However, there is marked variation in management, including between units of different designation, suggesting a need to review practice to fulfil new resuscitation guidance, which will have training and resource implications.

Title “Heartlight – Delivery room acquisition time for a novel forehead heart rate sensor for newborn resuscitation”
Authors Ward, C.; Teoh, J.; Grubb, M.; Crowe, J.; Hayes-Gill, B.; Marlow, N.; Sharkey, D.
Publication Pediatric Research, Vol. SUPP 1, pp. 480, November 2010.
Link https://doi.org/10.1203/00006450-201011001-00962
Abstract Background: Approximately 10% of newborn babies require some form of resuscitation at birth. Heart rate (HR) is one of the best indicators of effective resuscitation and is currently assessed with a stethoscope. However, this is not continuous, can interrupt resuscitation and is calculated incorrectly in 20-30% of cases. Pulse oximeters, attached to limbs, are not designed for monitoring HR and are unreliable in low perfusion states frequently observed in sick newborn infants. Use of a forehead HR sensor would be advantageous allowing quick placement, continuous monitoring and improved reliability in low perfusion states.

Aims: Develop a user friendly, quick and reliable forehead HR sensor for use in newborn infants requiring delivery room resuscitation.

Methods: We have developed a forehead HR sensor (HeartLight), utilising patented reflectance photoplethysmography technology, to detect changes in pulse volume with a rapid acquisition time. The HeartLight can be sited within ten seconds. Following the development in the NICU, we examined the acquisition time of the HeartLight sensor in the delivery room in term newborn babies (birth weight 3263±486g, n=16). Time to acquire a reliable signal was measured from the time the sensor was activated.

Results: Median time to obtain the first two consecutive pulsations was 1.8 seconds (IQR 1.4- 8.0s) and the first ten consecutive pulsations was 13.2 seconds (IQR 4.4-50.8s).

Conclusion: The HeartLight sensor may offer a simple, quick and continuous way to monitor the newborn HR during delivery room resuscitation. HeartLight is currently undergoing further development and clinical trials in preterm deliveries.

Title “Variation of Delivery Room Resuscitation Practice in the UK”
Authors Ward, C.; Grubb, M.; Crowe, J.; Hayes-Gill, B.; Marlow, N.; Sharkey, D.
Publication European Academy of Paediatric Societies, October 2010, Copenhagen.
Title “Evaluation of a novel photoplethysmography forehead heart rate sensor for newborn resuscitation”
Authors Grubb M R.; Crowe J A.; Sharkey D.; Ward C.; Marlow N.; Teoh J.; Hayes-Gill B R.
Publication Institute of physics and Engineering in Medicine (IPEM) (Eds.), Proceedings of the Medical Physics and Engineering Conference (MPEC) and Bioengineering 10, Nottingham: 14th-16th September, 2010, pp. 115.
Title “Variation in current UK and international delivery room resuscitation practice”
Authors Mann, C.;  Ward, C.; Hayes-Gill, B.; Crowe, J.; Grubb, M.; Marlow, N.; Sharkey, D.
Publication Summer Meeting of the Neonatal Society, June 2010, Nottingham.
Title “Neopulse – heart rate acquisition time for a novel forehead sensor for use in the delivery room”
Authors Ward, C., Sharkey, D., Hayes-Gill, B., Grubb, M., Crowe, J. and Marlow,
Publication N. Midlands Matters Neonatal Conference, Wolverhampton, UK. 28th January 2010.
Title “Neopulse – heart rate acquisition time for a novel forehead sensor for use in the delivery room”
Authors Sharkey D.; Hayes-Gill B R.; Grubb M. et al.
Publication Acta Paediatrica, Vol 98, Pages: 233-233 , Suppl. 460, October 2009

SurePulse engineering publications

 

Title “Motion limitations of non-contact photoplethysmography due to the optical and topological properties of skin”
Authors Butler, M. J.; Crowe, J. A.; Hayes-Gill B R.; et al,
Publication PHYSIOLOGICAL MEASUREMENT Volume: 37 Issue: 5 Pages: N27-N37 Published: MAY 2016
Link https://www.researchgate.net/publication/301562345_Motion_limitations_of_non-contact_photoplethysmography_due_to_the_optical_and_topological_properties_of_skin
Abstract Non-contact photoplethysmography (PPG) provides multiple benefits over in-contact methods, but is not as tolerant to motion due to the lack of mechanical coupling between the subject and sensor. One limitation of non- contact photoplethysmography is discussed here, specifically looking at the topology and optical variations of the skin and how this impacts upon the ability to extract a photoplethysmogram when a subject moves horizontally across the field of view of the detector (a panning motion). When this occurs it is shown that whilst the general relationships between the speed of traversal, detection area and resultant signal quality can be found, the quality of signal in each individual case is determined by the properties of the area of skin chosen.
Title “A single-chip CMOS pulse oximeter with on-chip lock-in detection”
Authors He, D.; Morgan, S.; Trachanis, D.; Van Hese, J.;Drogoudis, D.; Fummi,  F.; Stefanni, F.; Guarnieri , V.; Hayes-Gill, B.
Publication Sensors, Volume 15, Issue 7, pages 17076-88, June 2015
Link https://doi.org/10.3390/s150717076
Abstract Pulse oximetry is a noninvasive and continuous method for monitoring the blood oxygen saturation level. This paper presents the design and testing of a single-chip pulse oximeter fabricated in a 0.35 µm CMOS process. The chip includes photodiode, transimpedance amplifier, analogue band-pass filters, analogue-to-digital converters, digital signal processor and LED timing control. The experimentally measured AC and DC characteristics of individual circuits including the DC output voltage of the transimpedance amplifier, transimpedance gain of the transimpedance amplifier, and the central frequency and bandwidth of the analogue band-pass filters, show a good match (within 1%) with the circuit simulations. With modulated light source and integrated lock-in detection, the sensor effectively suppresses the interference from ambient light and 1/f noise. In a breath-hold and release experiment, the single chip sensor demonstrates consistent and comparable performance to commercial pulse oximetry devices with a mean of 1.2% difference. The single-chip sensor enables a compact and robust design solution that offers a route towards wearable devices for health monitoring
Title “Application of usability engineering to the development of a novel neonatal heart-rate monitor”
Authors Teoh J.; Grubb M R.; Crowe J A.; Sharkey D.; Marlow N.; Martin J.; Sharples S.; Hayes-Gill B R
Publication Institute of Physics and Engineering in Medicine (IPEM) (Eds.), Proceedings of the Medical Physics and Engineering Conference (MPEC) and Bioengineering 10, Nottingham: 14th-16th September 2010, pp. 73.

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References

Aziz, K., et al. (2020) Chair; “Part 5: Neonatal Resuscitation 2020 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care” Pediatrics January 2021,  147 (Supplement 1) e2020038505E;

Bajaj, M., Natarajan, G. et al. (2018), “Delivery Room Resuscitation and Short-Term Outcomes in Moderately Preterm Infants”. J Pediatr, 195, 33-38 e32.

Bonner, O., et al. (2016) “‘There were more wires than him’: the potential for wireless patient monitoring in neonatal intensive care” BMJ Innov BMJ Innov 2017;3:12–18.

Cusack, J., Fawke, J. (2012). “Neonatal resuscitation: are your trainees performing as you think they are? A retrospective review of a structured resuscitation assessment for neonatal medical trainees over an 8-year period” Archives of Disease in Childhood – Fetal and Neonatal Edition 2012;97:F246-F248.

Conde-Agudelo A., Diaz-Rosello, JL (2014) “Kangaroo mother care to reduce morbidity and mortality in low birthweight infants” Cochrane Database of Systematic Reviews 2014, Issue 4. Art. No.: CD002771.

CPSport.org.uk accessed from https://www.cpsport.org/resources/cerebral-palsy-key-facts-and-statistics/

Dawson, J., G. Schmölzer and J. Wyllie (2018). “Monitoring heart rate in the delivery room.” Seminars in Fetal and Neonatal Medicine 23.

Duran, R et al. (2008) “The impact of Neonatal Resuscitation Program courses on mortality and morbidity of newborn infants with perinatal asphyxia”. Brain and Development; Vol 30, Issue 1; 2008: 43-46

Grosso, A., et al. (2019) “Cost-effectiveness of strategies preventing late-onset infection in preterm infants” Arch Dis Child 2019;0:1–6.

HSIB (Healthcare Safety Investigation Branch) (2020) “Neonatal collapse alongside skin-to-skin contact “; National Learning Report accessed from https://www.hsib.org.uk/documents/238/hsib-national-learning-report-neonatal-collapse-alongside-skin-to-skin-contact.pdf

Luong, D., et al., (2019). “Cardiac arrest with pulseless electrical activity rhythm in newborn infants: a case series”; Arch Dis Child Fetal Neonatal Ed 2019;0:F1–F3.

Mann, C., et al (2012) “Marked variation in resuscitation practice: A national survey in the UK” Resuscitation 83 (2012) 607–611

MBRRACE-UK (2019). Draper ES, et al., on behalf of the MBRRACE-UK Collaboration. “Perinatal Mortality Surveillance Report” Leicester: The Infant Mortality and Morbidity Studies, Department of Health Sciences, University of Leicester.

Mizumoto, H. et al. (2012), “Electrocardiogram shows reliable heart rates much earlier than pulse oximetry during neonatal resuscitation”; Pediatr Int 2012 Apr;54(2):205-7.

NHS Resolution (2017) “Five years of cerebral palsy claims” Retrieved from https://resolution.nhs.uk/resources/five-years-of-cerebral-palsy-claims/

NHS Resolution (2019) “The Early Notifcation scheme progress report”  Retrieved from https://resolution.nhs.uk/wp-content/uploads/2019/09/NHS-Resolution-Early-Notification-report.pdf

NHS Resolution Annual Report 2019/20 Retrieved from https://resolution.nhs.uk/wp-content/uploads/2020/07/NHS-Resolution-2019_20-Annual-report-and-accounts-WEB.pdf

ONS Neonatal Mortality England/Wales by Region 2019. Retrieved from https://www.ons.gov.uk/peoplepopulationandcommunity/birthsdeathsandmarriages/deaths/datasets/deathsregisteredinenglandandwalesseriesdrreferencetables

Van Vondren J et al (2014) “Pulse Oximetry Measures a Lower Heart Rate at Birth Compared with Electrocardiography” The Jnl of Pediatrics, 2014,

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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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Rohan Byrt


Quality and Operations Manager

Rohan has several years’ experience within the electronics industry at both startups and multinationals. In various positions he has overseen the certification process for numerous international accreditation marks (CE, CB, CCC) and managed the transfer of new designs to manufacture.

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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 a Clinical Associate Professor of Neonatal Medicine and honorary consultant neonatologist at Nottingham University Hospitals. He has overseen previous published newborn baby trials in both the Neonatal Intensive Care Unit and delivery room.

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