Respiratory rate is expected to offer an early warning for the subsequent deterioration of hospitalized COVID-19 patients. Outside the ICU, it is typically assessed in a manual exam by hospital staff. But infection control measures and a high patient burden can make it difficult to assess these indicators often enough and to analyze that data in a useful way.

Amsterdam-based Royal Philips NV has launched a five-day, wearable biosensor patch that monitors respiratory and heart rates once every minute, as well as assesses contextual information such as posture, activity level and ambulation. The wearable, disposable patch, dubbed the Philips Biosensor BX100, has received FDA clearance and a CE mark and is intended for use in lower acuity hospital care.

That data can then be fed into an analytics software system, known as Intellivue Guardian, that integrates it with other patient monitors and electronic medical record information to implement an early warning scoring system designed to identify patients about to deteriorate. It offers customizable alerts to health care providers and a modular software approach that can enable variable levels of systematic integration.

Predictive monitoring

“Respiratory rate changes manifest well before many of the other things such as blood pressure and oxygen saturation do, which means that it's a leading indicator,” Ravi Kuppuraj, general manager of General Care within the Philips Monitoring Analytics Business and Connective Care, told BioWorld. “Unfortunately, traditionally it's also one of those vital signs that has been measured very poorly because it's very manual. It's kind of awkward for nurses to do consistently, so it's been measured poorly as well.”

“We built an entire solution including a sensor that measures respiratory rate continuously and accurately, along with heart rate, etc. Then we actually looked at how can that be integrated, not just a sensor by itself, but really how can that be part of a complete workflow and solution,” he continued. “COVID manifests as a respiratory disease. Respiratory rate is a great indicator for not just actual confirmation of COVID, it is actually a significant component of a predictor of COVID deterioration along with other parameters.”

The system has been in development for years, but the regulatory process was accelerated to enable its use with the COVID-19 patient population as the ranks encompassed by the pandemic continue to swell. The disposable, five-day patch is intended specifically for use on adults.

Vital sign wireless wearables have been advancing rapidly over the last decade with significant uptake, particularly in at-home care and bridging from hospital to home. But hospital adoption has lagged, as institutions have substantial training and investment in existing wired vital sign monitoring systems that are difficult and costly to replace. COVID-19 seems to have the potential to shift that dynamic, as remote monitoring in the hospital becomes much more of a necessity rather than a luxury.

The Philips Biosensor BX100 is expected to prove useful for monitoring patients who have moved out of the ICU and into the general care area of the hospital. Relapse is common at this stage, so prevention is key. Various interventions can be helpful if deterioration is expected to be imminent including medication. But the point is to prevent an emergent situation in which a recovering COVID-19 patient suddenly has a collapse in vital signs.

“If the score is a certain number, the caregiver has an option to actually drill down and look at what are the parameters that are contributing to it. They can look to see for the patient what is what is most needed right now,” said Kuppuraj. “The other valuable thing with this is that they then have the option to call the physician or sometimes a rapid response team.”

“Now they have a system where they can point to and provide some very credible kind of background, context and the trending that has led to this event, which really provides the physician the ability to take the appropriate action with the correct level of urgency,” he added. “This means you really reduce the chances of the patient going into a code because you have intervened at an earlier point – and made the right intervention.”

Supply and demand

Philips is planning to disclose a couple of additional remote monitoring products for COVID-19 in the next few weeks. The company declined to comment on global production and distribution plans, beyond noting that the Philips Biosensor BX100 was developed and will be manufactured in the U.S. It aims to ramp up production through the year-end.

Hospitals in the Benelux nations, which consist of Belgium, the Netherlands, and Luxembourg, as well as those in Singapore already have indicated significant interest in acquiring the patch monitor with several moving to integrate the BX100 into their wards.

“During this unprecedented time of COVID-19, the Philips Biosensor BX100 helps provide rapid deployment for clinical surveillance to help decrease risk of exposure of health care workers while acquiring frequent patient vitals, and easing the demand for personal protective equipment (PPE),” said Peter Ziese, general manager monitoring and analytics at Philips. “The biosensor is an integral component in our Patient Deterioration Detection solution which helps aid in the identification of the subtle signs of deterioration in a patient’s condition at the point of care, hours before a potential adverse event would occur.”

Philips has a large footprint with a number of hospital and health care system customers, including in the ICU, imaging and patient monitoring. BX100 demand is coming both from existing Philips customers, who can integrate it with existing Philips systems, as well as from new customers.

The Patient Deterioration Detection Solution consists of the BX100 wearable sensors, other patient monitors and the Intellivue Guardian Software. Amsterdam hospital OLVG has already implemented the system for remote monitoring of diagnosed or suspected COVID-19 patients who don’t need ventilation and have been placed in isolation.

“With the help of this new biosensor, we can continuously and remotely monitor patients, which is especially important on the COVID-19 wards,” said Florian van der Hunnik, chief nursing information officer and team leader of the COVID-19 ward at OLVG. “Because we cannot walk in and out of the patient rooms without protective gear, we welcome this innovation as it helps improve how we can do our jobs better.”