Toumaz Technology conducts clinical trial of Sensium-enabled wireless body monitor
3 November 2009
Toumaz Technology Limited has announced that it has begun clinical trials of its Sensium 'digital plaster' wireless body monitor.
The trial of the ultra-low power, ultra-small size body monitoring system is being conducted by a specialist clinical research team at Imperial College London.
The study, which is being funded by global healthcare corporation CareFusion (a recent spin-out of Cardinal Health) and conducted at St Mary’s Hospital (part of Imperial College Healthcare NHS Trust) is expected to demonstrate the high quality physiological data that can be continuously acquired by wireless, unobtrusive Sensium-enabled devices. Initial results are expected by the end of December this year.
In the milestone trial, volunteers and patient groups will be provided with a wearable Sensium digital 'plaster' or patch that can continuously monitor multiple vital signs, including temperature, heart rate and respiration.
The focus of the trial will be to verify that the physiological data acquired by the digital plaster system within a clinical setting is equivalent to that acquired using current gold-standard monitors in use in hospitals — equipment that is often bulky, expensive and fixed, such that patient mobility is impaired.
The Sensium digital plaster is wireless and unobtrusive, meaning that patients can remain ambulatory in hospital while still being monitored. This flexibility allows continuous vital sign monitoring to be extended to patients who would not normally be monitored, thereby offering the potential to increase patient safety.
The Sensium digital plaster is a disposable device with a working lifetime of several days, after which the plaster is disposed of in the appropriate waste receptacle.
The trial is being conducted in three phases, an initial phase with non-patient volunteers followed by two patient study groups: patients recovering from surgery, and patients with specific medical conditions in the general wards.
The digital plaster is based on Toumaz’s new generation AMx semiconductor IP platform, which enables Sensium wireless technology that has been specifically designed for Medical body area networks (MBANs) and non-intrusive physiological monitoring.
Sensium provides the complete wireless infrastructure to allow healthcare providers to monitor the human body continuously, wirelessly and intelligently and at low-cost, with the robustness and medical compliance normally associated with considerably more expensive capital equipment. Sensium technology has already been validated and CE marked in Toumaz’s Life Pebble non-disposable body worn monitoring devices.
The Sensium digital plaster is targeted for use in clinical monitoring applications such as acute care, general ward environments, tele-care, chronic disease monitoring, and in care home settings. For all these applications, disposability provides convenience, simplicity and patient comfort while ensuring infection control is maintained to the highest standards.
Powered by thin batteries, body-worn Sensium-enabled monitors deliver clinical-quality data and intelligently integrate it into an electronic medical record via a network built on Toumaz’s power-optimised wireless operating and networking system, Nano Sensor Protocol (NSP).
Dr Stephen Brett, a Consultant in Intensive Care Medicine at Imperial College Healthcare NHS Trust and an Honorary Senior Lecturer at Imperial College London, who is leading the trial, explains: “This technology has the potential to improve the capturing of patient’s vital signs within all areas of the hospital — enabling key physiological data to be acquired at an increased frequency, with the minimum of inconvenience to patients, and without the requirement to connect patients to immobile pieces of equipment.
"This raises the possibility of technology: improving hospital safety systems; enhancing the efficiency of adding vital sign data to patient records: and potentially freeing valuable nursing staff time for other patient care responsibilities.”
Toumaz Technology Co-Founder Keith Errey commented, “This is a very significant step on the path towards pervasive deployment of Sensium-enabled monitoring devices across a range of healthcare settings.
“Current patient data acquisition systems are mostly hospital-based, expensive, generally wired, and non-mobile. Even so-called portable equipment is still large, and prohibitively expensive for widespread use.
"Our Sensium technology platform is the step change that enables the development of clinical grade yet low-cost and unobtrusive wireless body monitoring solutions for the first time. We are tremendously excited with the success so far of this important trial in partnership with Imperial College London.”
Professor Chris Toumazou FRS, CEO and Founder of Toumaz Holdings, and Director of the Institute of Biomedical Engineering at Imperial College London, added: “It is fantastic to see the Sensium technology coming to commercial fruition, and for us to be launching this study at Imperial College Healthcare NHS Trust.
"This is a key stage in our commercial journey and one that opens the door to some very exciting applications of our technology in clinical environments next year.
“The business case is simple: by using the disposable digital plaster to monitor on a 24-7 basis, critical medical information can be monitored that would not otherwise have been detected. This preventative form of medicine will mean that less people could require intensive care in the future, saving lives and at the same time providing greater efficiencies and cost savings to the NHS. Once proven in a hospital setting then the digital plaster can be deployed in the home in the same way.”