Advice
The technology
The technology
The Patient Status Engine (PSE; Isansys Lifecare Ltd) is a wireless patient monitoring system that provides automatic and continuous real-time monitoring. It is indicated for people who need frequent or constant vital signs monitoring.
The system uses wireless wearable biosensors to collect vital signs data. These include:
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The Lifetouch sensor. This single-use sensor captures real-time electrocardiogram (ECG) signals and information about heart rate, heart rate variability and respiratory rate. It has a 3‑axis accelerometer that gives data on a person's position, activity, and motion. It can be used continuously for 4 to 5 days.
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The Lifetemp sensor. This is a continuous real-time clinical thermometer. It is placed in the armpit to measure core body temperature. The single-use sensor takes temperature readings every 10 seconds and updates every minute. The company states it accurately tracks temperature for approximately 10 days or more and can detect rapid temperature changes.
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The Nonin WristOx2 3150 oxygen saturation monitor. This is a wireless pulse oximeter with Bluetooth connectivity and PPG waveform capability.
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A choice of 2 blood pressure monitors: a standard manually operated inflatable cuff device or an automated ambulatory blood pressure monitor. For both devices, blood pressure readings are automatically uploaded.
The company states other sensors can be integrated into the system. These include a tympanic temperature sensor for people who only need occasional temperature readings. Another third-party pulse oximeter is also being integrated into the system.
Lifetouch and Lifetemp sensors are stuck to the body using a repositionable medical-grade silicone gel adhesive. The company also produces paediatric sensors in different sizes for newborns, babies, and children.
Sensors are paired with an Android tablet with Isansys apps by scanning a QR code on each sensor. Data is transmitted wirelessly by encrypted Bluetooth from the sensors to the tablet and viewed in the Patient Gateway. The Patient Gateway provides a real-time display of vital signs like a wireless bedside monitor. The PSE converts vital signs data into early warning scores, which alert healthcare professionals to a person's physiological deterioration. Healthcare professionals can use the Patient Gateway to set early warning thresholds and to enter patient data. The default early warning score for adults is the National Early Warning Score (NEWS) 2. This is calculated from a person's continuous vital signs data plus manually entered data for air or oxygen and consciousness level.
The Patient Gateway is connected by secure Wi-Fi, 3G or 4G to the Lifeguard Server. This is the IT system that connects to electronic medical records and hospital information systems. Vital signs data can be viewed in real time by healthcare professionals at the central monitoring unit. This is a centralised computer on site that lets healthcare teams monitor vital signs data and alert ward staff should a person need care. Alerts from the PSE can also be sent directly to care teams through connections to nurse call systems and SMS gateways. Healthcare professionals can also view PSE data on authorised mobile devices. Healthcare teams can set the system to let patients view their own vital signs data.
The PSE will generally be used for continuous monitoring for a few days to about a month. The company states that batteries typically last 4 to 5 days.
Innovations
The PSE automates the taking of continuous vital signs measurements. The company claims this may lead to better nurse efficiency, fewer errors from incorrect data entry, and fewer adverse events. The PSE aims to replace wired bedside monitors, which may limit movement because of cables and leads. It would let people move more easily while still being closely monitored.
Current care pathway
The PSE is for people who need frequent or continuous monitoring of their vital signs. It is not limited to specific medical conditions.
Adults in acute hospital settings have physiological measurements taken during their initial assessment or admission. This should include heart rate, respiratory rate, systolic blood pressure, level of consciousness, oxygen saturation, and body temperature. These vital signs should then be monitored at least every 12 hours unless decided otherwise based on the person's needs.
Early warning score 'track and trigger' systems are used to alert healthcare professionals to any deterioration in a person's health. The NEWS is endorsed by NHS England and NHS Improvement and is currently used in all ambulance trusts and 76% of acute trusts. Vital signs monitoring may also be done in babies and children using the appropriate early warning scoring system for their age.
Physiological measurements are usually taken by healthcare professionals who manually enter the data into electronic health records. A person may also be continuously monitored using a wired bedside monitor which is connected to them by cables and leads. There should be a clear written monitoring plan of which vital signs measurements should be taken and how often.
The following publications have been identified as relevant to this care pathway:
Population, setting and intended user
The company describes the PSE as a universal patient monitoring system. It can be used by most patients and particularly people who need more monitoring than others. The technology can be used in secondary, tertiary, and social care settings including:
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postoperative care
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home care when intensive monitoring is needed
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care homes
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paediatric and neonatal care.
It is not indicated for use in intensive care units because the PSE has not been fully tested and validated with the other equipment in this setting. The PSE is also not intended to be used by people in high isolation wards or people with diseases caused by prions. The device's quick start guide states that the PSE has not been tested:
So, it should not be used by these people or in these circumstances.
Healthcare professionals should read and follow the safety information in the quick start guide that comes with the device before use.
The PSE can be used by doctors and nurses. Training is needed on how to set up and use the technology. The company states that this could be done with 2 hours of formal training. Training can be delivered in person or online through the company's training platform. This includes video and written training materials, and self-learning modules. Training is included in the technology costs.
Costs
Technology costs
The company states the costs of the PSE depend on the size of the installation, including how many people and which vital signs are being monitored. The technology is estimated to cost £10 to £30 (excluding VAT) per person per day. This includes the costs of the technology, setup, training, support, and integration into the site's electronic medical records or hospital information system. The company recycles used Lifetouch and Lifetemp sensors and claims there are no costs to clean the devices or change batteries. The company claims the technology costs less than standard care and is cheaper to scale. There is no published evidence to support this.
Costs of standard care
Costs of multiparameter patient monitors listed on NHS supply chain range from around £800 to £15,000 (excluding VAT). The number of vital signs measured varies depending on the monitor used. The costs of single use sensors are approximately £30 to £550 (excluding VAT) while multiuse sensors range £40 to £1,500 (excluding VAT). There may be additional costs for replacement cables and leads. Locally agreed prices may differ.
Resource consequences
In the UK, the PSE has been used for the continuous monitoring of people with advanced cirrhosis, people with cancer having chemotherapy, people with COVID‑19 in hospital, people in care homes, children admitted for elective procedures or emergency care, and premature babies. The PSE is also being used to explore new care pathways, such as the development of a new standard care pathway for paediatric wards using continuous monitoring. The company believes continuous monitoring using wireless technology and data-driven clinical decision support tools will become standard care for all patients.
The company believes using the PSE will lead to benefits, including:
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fewer avoidable adverse events
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shorter hospital stays with an increase in home care
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fewer nurse shortages because time taking vital signs can be used elsewhere.
Imperial College Healthcare NHS Trust described resource benefits from the use of digital bedside vital signs monitors to generate NEWS. These were not the PSE, but the trust's experiences provide information about the resource consequences of using digital monitors instead of standard care. Using digital bedside monitors resulted in standardised patient assessment and automatic entry of vital signs data to the medical record. Improved outcomes included more accurate information, increased referrals and patient safety, and decision-making support for healthcare professionals. The technology also led to more streamlined and integrated care.
For full system connectivity, the PSE needs secure and reliable Wi-Fi to connect the Patient Gateway to the Lifeguard Server. For home care, good 3G or 4G connectivity is preferred but Wi-Fi can also be used. Loss of wireless connectivity will not cause data loss as the data is stored in the sensors and the Patient Gateway until connectivity returns.