Oxford BioSignals starts clinical trials in US of BioSign patient monitoring technology

3 March 2005

Oxford BioSignals (OBS), a Rolls Royce-backed ‘spin-out’ company from Oxford University, announces the start of clinical studies in Indianapolis, USA, in conjunction with Clarian Healthcare, for its BioSign patient monitoring technology. Biosign combines data from the patient’s five vital signs (heart rate, respiratory rate, temperature, blood pressure and blood oxygen saturation) to produce a BioSign Index by applying complex signal processing and intelligent algorithms. The clinical studies are targeted at using the technology to provide early warning of severe patient deterioration in advance of traditional methods.

A two year ‘blind’ trial at the John Radcliffe Hospital in Oxford, UK, is due to complete in June 2005. Matthew Walls, Chief Executive Officer of Oxford BioSignals, explains, The trials at the John Radcliffe Hospital are targeted at demonstrating that the early warning of patient deterioration provided by BioSign places it ahead of current patient monitoring practices says Walls. This early warning has significant implications for patient care a fact that has encouraged Clarian Healthcare in the US to undertake this trial.

Walls continues, Not only will the technology provide early warning of patient deterioration enabling timely intervention, but it is intended that BioSign also maintains a full audit trail from the time the alarm sounds to the time the patient is treated, automatically, says Walls.

The potential impact for the healthcare Industry is considered to be highly significant. Not only is this new technology seen as raising the standards of automated monitoring, but importantly it also provides an opportunity to reduce Intensive Care Unit (ICU) and High Dependency Unit (HDU) costs. The automated system and wireless alarm also enable care to be prioritised and promote the cost-effective deployment of valuable clinical resources.

Oxford BioSignals’ expertise is already being utilised within the industrial engineering market. In 2003 Rolls-Royce took a 30 percent share of the company and is incorporating Oxford BioSignals’ technology within the latest generation of its engines which will be powering the recently launched Airbus A380 and new Boeing ‘Dreamliner’ 7E7.

The signal processing technology is however particularly suited to medical patient monitoring. By using data fusion and advanced signal processing techniques, BioSign is able to integrate a patient’s vital signs including heart rate, respiration rate, body temperature, oxygen saturation, and non-invasive blood pressure, in order to present an overall picture of a patient’s status and to identify the early onset of deterioration.

By combining the five vital signs second by second, BioSign delivers a full representation of the patient wellbeing, the BioSign Index™ providing a composite assessment of a patient’s condition as opposed to the more limited assessment provided by a single physiological parameter.

Walls explains, “The BioSign monitor is also expected to require little additional training for nursing staff. When a Patient’s BioSign Index moves out of the normal range, indicating a deterioration in patient condition, BioSign will alarm and provide the attending nurse with a trend and index of a patient’s condition based on the current vital sign values.”

The US outcome trial is being conducted in conjunction with the US-based Clarian healthcare group. The three phase trial is taking place in Indianapolis within three trauma units at the Methodist Hospital, enabling the technology to be deployed across a range of patient types from emergency admissions to post operative care. During the first phase, the patient will simply undergo standard nurse-based monitoring; in the second, the patient will be monitored with a multi-parameter bedside monitor and, in the third, BioSign will be used, connected to the bedside monitor to provide a BioSign Index™.

This US trial will include between 250 to 350 patients and will be conducted over the next 10 months. It will also include the use of telemetry to alert nursing staff to patient alarms: i.e. when BioSign alarms a wireless call is immediately placed to the nursing staff to ensure rapid response.

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