LONDON Toumaz Technology Ltd. has begun clinical trials of its Sensium 'digital plaster' wireless body monitor 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 quality of physiological data that can be continuously acquired by wireless, unobtrusive Sensium-enabled devices. Initial results are expected by the end of December this year.
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 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.
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).
“This is a very significant step on the path towards pervasive deployment of Sensium-enabled monitoring devices across a range of healthcare settings,” said Keith Errey, co-founder of Toumaz Technology. “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.”