Clinical Need for accurate, wireless Neonatal Heart Rate Monitoring

Clinical needs

For accurate, wireless neonatal heart rate monitoring

Around 1 in 10 babies are in need of some form of stabilisation at birth.

The heart rate of the baby is critical for guiding the stabilisation or resuscitation process; however, current monitoring methods do not always provide an early enough or sometimes an accurate enough heart rate which can lead to inappropriate clinical interventions (Voogdt). Adherence to guidelines is sub-optimal (Mann, Cusack) which impacts on babies’ welfare, their families, and healthcare resources.

SurePulse VS represents a significant innovative and baby-centric step forwards in addressing the clinical need for accurate, wireless neonatal heart rate monitoring.

Neonatal clinical challenges

The correct care of the newborn baby in the first few ‘golden’ minutes after birth is critical to prevent significant illness or even death. A rise in heart rate is the most important indicator of effective ventilation and response to resuscitation interventions (Aziz). Establishing a timely and accurate heart rate and monitoring it through stabilisation (and resuscitation where needed) supports optimal clinical decision making. However, current heart rate assessment is often not quick enough, is cumbersome, or underestimates heart rate leading to overtreatment, representing ongoing neonatal clinical challenges (Dawson, Bajaj).

Neonatal Clinical Challenges

Every second counts

If you want to learn how to overcome these neonatal clinical challenges using SurePulse VS wireless monitoring, contact us to learn more.

Adherence to guidelines

Receiving the right information at the right time is essential for adherence to guidelines, yet ‘guideline errors’ exist and there is significant variation from gold-standard protocols such as the Newborn Life Support Guidelines in the UK (Cusack, Duran).

Delayed resuscitation can have significant consequences. In 2017 there were 1,267 neonatal deaths in the UK, 68% of them between birth and 7 days, 119 of them were from cardio-respiratory causes (MBRRACE 2019).

Training, teamwork, and access to timely accurate information remain opportunities that SurePulse VS can help address. The clinical need for accurate, wireless neonatal heart rate monitoring is evident.

Neonatal Deaths

Shortcomings of current neonatal heart rate monitoring

stethoscope heart rate assessments

SurePulse VS addresses many of the neonatal clinical challenges associated with current approaches to heart rate assessment:

  • Pulse oximetry significantly underestimates heart rate in the first 2 minutes after birth (Van Vonderen);
  • ECG, where available is fast and accurate, however, is also associated with skin injury and the electrodes are easily dislodged (Mizumoto).
  • Stethoscope-assessed heart rates in the delivery room are inaccurate around one-third of the time, 28% of those to the extent that inappropriate clinical decisions are indicated (Voogdt).

Patient safety and managing risk

Whilst infrequent events, both Pulseless Electrical Activity (PEA) and Sudden Unexpected Postnatal Collapse (SUPC) continue as neonatal clinical challenges associated with poor outcomes for babies and their families. SurePulse VS with the cap-mounted wireless, continuous and real-time heart rate monitoring can support new advances in risk mitigation (HSIB, Luong).

Overcoming clinical challenges

If you want to learn more about SurePulse VS and the opportunities to address neonatal clinical challenges, please contact us.

Barriers to skin-to-skin care

SurePulse VS opens possibilities to enhance family integrated care for newborn babies, as heart rate can be monitored wirelessly allowing more confident early bonding and breastfeeding opportunities.

In addition, the wireless heart rate monitoring and data/event recording features support several evolving delivery room practices including delayed cord clamping, quality improvement, perinatal MDT teamwork, and less-invasive approaches to stabilisation/resuscitation.

baby with wires

“There were more wires than him” (Bonner)

Societal impact of poor neonatal outcomes

  • A slow heart rate in a newborn infant at 5-minutes of age is associated with a significantly higher risk of brain injury or death.
  • Cerebral Palsy (CP) can be one of the consequences of birth trauma and there are 1,800 new cases of CP diagnosed in the UK each year (cpsport.org.uk)
  • Cerebral Palsy costs £1 million / child on average, quality of life-adjusted years is reduced by 10.6yrs and life expectancy by 15-years (Grosso 2019).
  • NHS Resolution claims totalled £4.37bn in 2016-17, of which Obstetric claims, mostly birth-related, represent 50% of the value (NHS Resolution ‘5 Years’ report).
  • The majority (approximately 70%) of the NHS Resolution provision is as a result of claims arising from the brain damage of babies at birth from negligent care (NHS Resolution Annual Report 2019/20).
  • The value of the claims has increased in excess of 35% year-on-year since 2004 (NHS Resolution ‘5 Years’ report).
  • There is an 82% regional variation in neonatal mortality across England and Wales (ONS 2019).
  • Babies who don’t receive regular skin-to-skin tend to have extended lengths of stay in hospital, (typically 2-days) and have poorer health outcomes (Conde-Agudelo).

The value of clinical negligence claims received in 2016/17 by speciality

The value of clinical negligence claims received in 2016/17 by specialty

A comparison of the number and total value of claims for cerebral palsy and neonatal brain damage claims over time

A comparison of the number and total value of claims for cerebral palsy and neonatal brain damage claims over time

Supporting optimal neonatal care

If you want to learn how SurePulse VS may help mitigate neonatal risks and enhance family integrated care, please contact us.

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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