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Original research
Functionality and acceptability of a novel non-invasive neonatal heart rate monitoring device: a qualitative study of healthcare professionals
  1. Oana Anton1,
  2. Ramon Fernandez1,2,
  3. Elizabeth Rendon-Morales3,
  4. Rodrigo Aviles-Espinosa3,
  5. Christina J Jones4,
  6. Heike Rabe1,2
  1. 1 Trevor Mann Baby Unit, Brighton and Sussex University Hospitals NHS Trust, Brighton, UK
  2. 2 Academic Department of Paediatrics, Brighton and Sussex Medical School, Brighton, Brighton and Hove, UK
  3. 3 Robotics and Mechatronics Systems Research Center, School of Engineering and Informatics, University of Sussex, Brighton, Brighton and Hove, UK
  4. 4 Department of Psychology, Faculty of Health and Medical Sciences, University of Surrey, Guildford, Surrey, UK
  1. Correspondence to Dr Oana Anton, Department of Neonatology, Brighton and Sussex University Hospitals NHS Trust, Brighton BN25BE, UK; o.anton{at}nhs.net

Abstract

Background Detecting neonatal heart rate rapidly and accurately at birth is essential if resuscitation is required. The Neo-Sense prototype provides a quick, non-invasive method to measure neonatal heart rate at birth based on electric potential sensing technology. The study aimed to inform the prototype design process by exploring the required features and usability of this novel device among healthcare professionals.

Methods Face-to-face, semistructured interviews were conducted with healthcare professionals involved in the immediate care of babies at birth: paediatricians, midwives and neonatal nurses. Interviews were audio-recorded and subsequently transcribed verbatim. Two independent researchers coded and extracted the emerging categories and performed a thematic content analysis.

Results In total, 21 participants were interviewed, 7 from each professional group. Participants expressed a positive attitude towards the novel prototype. The three main themes extracted were anticipated limitations, advantages and suggestions for development and usage. Participants preferred a device that is easy to use and attach, one which is positioned in a mattress or pad, maintaining also the option of being mobile. Education was considered to have a key role in addressing staff anxiety. The ideal features most frequently mentioned were speed of assessment, reliability and accuracy.

Conclusions The study enabled a better understanding of the perceived barriers and facilitators to developing a new heart rate monitoring device. The development of a quick and accurate device would have immense implications for clinical practice and the potential to improve neonatal mortality and morbidity.

  • neonatology
  • diagnostics
  • monitoring
  • heart rate

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Background

Heart rate is the most important clinical indicator to evaluate the cardiorespiratory status of a newborn and is used to guide resuscitation efforts.1 Heart rate during the first minutes of life in infants needing resuscitation may be a predictor of neonatal mortality and moderate to severe brain injury in those who survive.2

The literature describes several established methods to determine heart rate at birth, such as palpation, auscultation, pulse oximetry and electrocardiography (ECG). ECG remains the gold standard to continuously monitor an infant’s heart rate in the neonatal intensive care unit (NICU).3 Both ECG and pulse oximetry are considered to be more precise than auscultation and palpation,3 4 but studies have shown that the time from birth to successful heart rate display using these devices often exceeds 1–2 min.5 6

Novel techniques are increasingly mentioned in the literature, but each modality has its own limitations, most commonly movement artefacts.4 7

Special consideration is given in the literature to non-invasive methods which minimise noxious stimuli and infection pathways, especially for vulnerable preterm infants.4

Our research group is collaborating to offer a quick and accurate technological solution to detecting heart rate at birth. The Neo-Sense prototype is based on electric potential sensing technology. This technology was invented at the University of Sussex as a non-invasive sensing technology.8 The sensor is a feedback-enhanced and stabilised electrometer-based amplifier that operates on displacement current measurements.

We considered different options when building the prototype, such as embedding the sensors into a neonatal mattress or imprinting them on a textile in a pad or a strap. Figure 1 is a diagram of the proposed prototype incorporated into a mattress.

Figure 1

Schematic of the smart-mattress (top) and the sensor design implementing the EPS (bottom). Ag, silver; Ce, capacitance; Cin, capacitance in; EPS, electric potential sensor; Id, inductance; Rin, resistance in; RG1 and RG2, resistance; Vin, input voltage; Vs, voltage sample.

For all options, the baby would be placed in close contact but without the need to attach the sensor to the baby’s skin. If the sensors are incorporated into the mattress, the baby will be placed on top of the sensor. Neo-Sense has the potential to improve clinical practice in a resuscitation scenario by eliminating the considerable delay caused by the time to attach a heart rate monitoring sensor.

Aims of the study

The study aims were to inform the Neo-Sense prototype design process by exploring healthcare professionals’ perspectives on the required features and usability of this novel device. This would enable us to ascertain the most important requirements for the Neo-Sense sensor.

Methods

Recruitment and consent

The qualitative study was conducted in a level 3 NICU and a labour ward. As advised by the Hospital Trust Research and Development Department, the study was considered a service evaluation project as it explores the opinions of healthcare professionals, in an effort to improve heart rate monitoring in newborn babies. The project was registered with the Trust Clinical Governance Department as per hospital policy. The study was exempt from ethical approval and this decision was supported by the UK Health Research Authority tool kit.9 All participants provided written consent to be interviewed. Data from the interviews were anonymised and stored securely on a password-protected computer. Participants were healthcare professionals involved in the immediate care of babies at birth: paediatricians, midwives and neonatal nurses.

Interviews

Using purposeful sampling for face-to-face, semistructured interviews, we explored the features of the novel sensor.9 Interviews were held in a quiet and private environment away from clinical areas. The interview guide was designed based on the exploratory literature review on heart rate detection methods in neonates (online supplementary e-Table 1).10

Supplemental material

To stimulate discussion, participants were presented with a series of pictures of term and preterm manikins having attached ECG, pulse oximetry and the proposed Neo-Sense prototype in incipient stages. Participants were offered several options regarding positioning. Different possibilities such as having the sensor incorporated into a mattress, in textile pad or a strap around the baby were discussed. The researcher summarised the main features of the prototype and its functions. Each interview was audio-recorded, anonymised and transcribed verbatim.

Data analysis

Thematic content analysis using Burnard’s framework was conducted on the interview transcripts.11 12 This stage-by-stage process of analysing qualitative data enables the researcher to initially extract as many categories as possible.11 12 These categories are then used to generate themes and subthemes that are further explored in subsequent interviews. Microsoft Excel was used for data management. Two independent researchers coded and extracted the emerging categories, with several peer debriefing sessions to agree on categorisation and the final themes.

Results

Participants’ characteristics

In total 21 participants were interviewed, 7 from each professional group: paediatricians, midwives and neonatal nurses. Both junior and senior members of staff were included (table 1).

Table 1

Participants’ characteristics

Three major themes emerged from the interviews: perceived limitations, advantages of the novel sensor and suggestions for further development and usability. Each of these themes had several subthemes (figure 2).

Figure 2

Major themes and subthemes emerging from the interviews.

Perceived limitations of Neo-Sense sensor

Size

Some participants were concerned that the prototype looks big on the preterm manikin and that it would cover the baby’s chest for the pad option. This ultimately could affect the visual cues during a resuscitation scenario.

At the moment it looks quite thick but as you say it is a prototype. (1A)

It looks good, but it is big and it will cover a lot of area on the baby’s body. (4A)

It looks big and bulky compared with ECG. (20A)

When it is on the baby, I am worried that it covers the chest. (5A)

Placement and positioning

The second subtheme referred to perceived difficulties with positioning and placement. This subtheme has its own subcategories which were based on the different placement options. Among the most frequently mentioned disadvantages were movement artefact and the possibility of causing discomfort (table 2).

Table 2

Anticipated limitations due to placement of Neo-Sense

Staff anxiety with unfamiliar device

Apart from limitations due to size and placement, there were perceived difficulties linked to staff anxiety. These were subdivided into different categories. The main concerns were aimed at the babies’ comfort and safety, but some participants were intrigued by the device utilisation features, placement and connectivity (table 3).

Table 3

Anticipated difficulties related to staff anxiety

To address staff anxiety, most of the participants suggested targeted education and the use of visual aids such as instruction sheets on the resuscitaire or a set of instructions preattached to the device:

I am sure after training we should be ok. It might be ideal to have a little instruction sheet on the resuscitaire so people learn how to do it. Having little cards on resuscitaires with instructions, because a lot of people come to labour ward after a long time, so having instructions will help. (12A)

Cost

One of the participants considered the cost of Neo-Sense:

Having the sensor in a textile, it gets wet and you will have to change it very often. I am not sure how cost-effective that would be; I worry about the cost, disposability and cleanliness. (3A)

Several participants also discussed whether the sensor should be single use or reusable, which has a direct impact on cost. Opinions were divided, with some participants opting for reusable sensors, as these are better for the environment, and others single use or single sensor per baby for longer monitoring.

I would worry about cost, disposability and cleanliness because if it is the mattress the cleaning it might be a complex process. (14A)

Perceived advantages of Neo-Sense sensor

Overall positive attitudes towards Neo-Sense were observed due to all the perceived advantages. These were further explored under the second major theme and its related subthemes (figure 2).

Neo-Sense appearance

The Neo-Sense appearance made a significant impact on participants. The anticipated advantages were attributed to its non-obtrusive, simple nature and the lack of visible wires.

It looks much nicer probably for the baby as well he doesn’t have anything attached. (1A)

It is not like a scary medical device. (11A)

It looks tidy and simple; it looks good on the mattress. (4A)

It is fairly unobtrusive there isn’t much in the way. (8A)

It is quite small and non-invasive; it doesn’t look that it can cause any harm. (9A)

The material textile one looks nicer. (13A)

Healthcare professionals acknowledged that the Neo-Sense appearance was also likely to have a positive impact on parents:

I think as a parent going to see your child that is in a scary place anyhow it looks better than having all these wires. They are doing the same thing but visually it makes them think that their baby is very sick. (10A)

It doesn’t look scary from parents’ point of view. It doesn’t have that many wires. It can be hidden. (18A)

Usability and placement features

In terms of utilisation, participants perceived it to be easy to use, to set up and beneficial in case of emergency situations. Positioning of the device in the mattress but also having the option of being mobile is considered an advantage of this proposed novel device (table 4).

Table 4

Perceived advantages of Neo-Sense

One of the participants considered having the sensor strapped to the baby as an advantage.

It is the easiest as you can customise the size for each baby and wrap it around with Velcro you can get a snug fit. (11A)

Comfort

Two of the biggest anticipated advantages would be not affecting the preterm skin and reducing the stress and painful stimuli on babies.

The advantages will be that it will be quicker to move baby and transfer into a transport incubator. (3A)

Another advantage is that for very preterm babies we tend not to use ECG because they are so tiny so if they have an arterial line and a saturation probe, we use that for their HR [heart rate] and we don’t bother with ECG. This sensor could get a decent ECG trace with a rhythm for those babies that we can’t use ECG leads. (5A)

As Neo-Sense does not have to attach to the baby’s skin, it does not have to be removed during further investigations such as X-rays.

That probably is quite nice when babies are having X-rays you would not have to take ECG leads off. So, I think that would be really good, all you have to do it is just slip it off. If it is not sticky like ECG leads it would not affect the smaller babies, because you sometimes injure the skin when you do that. That is a good point. (8A)

Ideal features for Neo-Sense

The further aim of our study was to ascertain the most important requirements for the proposed device. After describing the perceived limitations and advantages, participants were prompted to offer suggestions for further development to improve uptake and usage.

Functionality

Participants reported a preference for a device that is “easy to use,” “easy to attach,” “self-explanatory” and “easy to maintain” (13A). At the same time, it should “have instructions for me to know exactly how to use it in an emergency situation as easy to understand as possible” (5A). Another important point raised was that it should not need changing position all the time and be “the least disruptive to the care of the baby” (1A).

When asked about its ideal features, participants mainly mentioned baby’s comfort, ease of use, reliability, speed of assessment, flexibility to go anywhere on the body and accessibility (online supplementary e-Table 2).

Supplemental material

Placement and positioning

The preferred placement was underneath the baby. Two participants suggested anterior placement in the case of premature babies or if the device was very small. Strapping was largely considered with the sensor mainly posteriorly especially for term babies, ongoing monitoring and to facilitate skin to skin with parents. Using a pad was mentioned by two participants, ideally a single pad slipped posteriorly.

To help with positioning, participants have made several suggestions especially if the sensor was to be incorporated into the mattress (online supplementary e-Table 2).

Participants were asked to give a rationale behind their choice of placement (online supplementary e-Table 3).

Supplemental material

Design preferences

Participants had other practical suggestions to improve the Neo-Sense device with regard to its material, aspect, connectivity and time to display. These categories spanned from improved features in terms of comfort for the baby, immediacy of results to improve clinical reporting as well as aesthetic improvements. They preferred a soft material with a child-friendly pattern that connects via Bluetooth to a monitor and as quick as possible to display a result (online supplementary e-Table 4).

Supplemental material

Discussion

In those babies who need significant help with transition after birth, heart rate has an essential role not only in guiding resuscitation efforts but also as a prognostic factor.2 13 14 There is an urgent need for a non-invasive technological solution to offer a quick and accurate heart rate measurement at birth. Furthermore, a flexible, portable device will support other interventions such as placental transfusion. The benefits of delayed cord clamping are well recognised in the literature and better monitoring will encourage its uptake on a global scale.14 15

Ultimately, Neo-Sense has the potential to become a wireless device which will enable using this technology remotely, to include different settings such as community birthing centres and developing countries. Future research studies in these areas could assess the impact on short-term and long-term neonatal health outcomes.

Participants initially commented on appearance and size and recognised that choosing the adequate size would be a key factor. Its minimal contact, non-adhesive features were perceived as an essential advantage. One of the goals of novel technology, as highlighted in multiple studies, is to minimise invasive patient contact and maintain the natural skin barrier. This would reduce skin damage and susceptibility to infection. In addition, these sensors should offer increased comfort by reducing mechanical and painful stimuli.16–20

The preferred placement was underneath the baby incorporated into a mattress, but having the option of a mobile, flexible device was seen as an advantage. Each option of placement has its limitations. Participants expressed careful consideration of the baby’s comfort and offered solutions to counteract these perceived limitations.

Healthcare professionals expressed anxiety towards this unfamiliar device utilisation features, its placement and connectivity. This should be addressed early in the design process and has an essential role in accepting the novel device for wider use. The anticipated limitations are in keeping with those mentioned in the literature. Other studies have suggested that the difficulties with novel sensors were mainly due to movement artefact, bad sensor coupling, intermittent measurement and poor-quality recordings.17–20 The majority of participants suggested addressing limitations and staff anxiety by providing targeted education and the use of visual aids with utilisation instructions.

Despite these anticipated limitations, we had an overall positive attitude towards the proposed novel device. This is due to multiple perceived advantages. Appearance was considered non-invasive, simple and with less visible wires. The potential positive impact on parents due to its non-obtrusive aspect is an important asset. Furthermore, the device is considered “easy to use, set-up and good in emergency situations” (3A).

Using a theoretical framework for acceptability as described by Sekhon et al 21 can guide the design of future comparison studies, from proof of concept, to evaluation and implementation studies. Acceptability would be influenced by the prototype’s ability to accomplish the most frequently mentioned ideal features. Nevertheless, careful considerations should be given to the prospective and retrospective cognitive and emotional responses towards the use of this new device. These can be further explored in future qualitative or quantitative studies.

The strength of this study is that it offers a multidisciplinary healthcare professionals’ perspective on the difficulties and advantages of this proposed method to detect heart rate on babies at birth.

The limitations are due to the influence of the researchers’ reflexivity.22 There is always an element of bias due to researchers’ own opinions of the device, the relationship with the participants and the influence of all these factors on the generated data. Further exploration of the anticipated advantages and limitations of the proposed prototype required a good understanding of the device features. This was enhanced through a continuous collaboration between the research group partners.23

Conclusions

The study enabled a better understanding of the perceived barriers and facilitators to developing a new heart rate monitoring device. Healthcare professionals’ involvement is a key component of this process offering vital information on its acceptability and functionality. For Neo-Sense to be accepted it has to overcome the anticipated limitations and prove its speed of assessment, reliability and accuracy when compared with the current methods, pulse oximetry and ECG. Further studies will be necessary at different stages through the development process. An accurate and quick technological solution to determine heart rate on babies at birth would have immense implications for clinical practice and potential to improve neonatal mortality and morbidity.

References

Footnotes

  • Contributors OA conceptualised the study, conducted the face-to-face interviews and transcribed verbatim. Data extraction and analysis were a collaborative effort. HR, RF and CJJ conceptualised the study, contributed to data analysis, reviewed and revised the manuscript. ER-M and RA-E provided technical advice, reviewed and revised the manuscript. All authors approved the final manuscript as submitted and agree to be accountable for all aspects of the work.

  • Funding The study was partially funded by the Rockinghorse Appeal and The Early Birth Association charities.

  • Competing interests None declared.

  • Patient consent for publication Not required.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data availability statement All data relevant to the study are included in the article or uploaded as supplementary information. Data generated by our research can be made available upon publication of our article.