Publications

Publications

Title

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

Abstract

Henry, CShipley, LWard, C, et al.

Acta Paediatr2020001– 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 Grubb1J Carpenter1J A Crowe1J Teoh1N Marlow2C Ward3C Mann3D Sharkey3 and B R Hayes-Gill1

Physiological MeasurementVolume 35Number 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.

Link

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