Clinical Developments

Developing clinical applications for our core competences

Revolutionary Sensor for Detecting Faecal Incontinence

March 2021

Revolutionary Sensor for Detecting Faecal Incontinence

Oxford Optronix Ltd is delighted to have received a UK government grant from the National Institute of Health Research (NIHR) to help fund the development of the world’s first device for reliably detecting and reporting adult faecal incontinence.

Commenting on the award, Dr Andy Obeid, CEO of Oxford Optronix said, ‘Faecal Incontinence occurs when someone is unable to perform normal toileting behaviour; it is a devastating social and hygiene problem that affects 2-3% of all adults - particularly those living with dementia and other neurodegenerative diseases. Faecal incontinence undermines dignity, damages skin, risks infection and is distressing for individuals, nurses, care-home staff and relatives alike.’

‘Oxford Optronix has developed a unique (and recently patented) technology that can reliably detect when a person has passed a stool in an incontinence pad. It uses an optical sensor to detect small quantities of fluorescent light produced by the bacteria present in faeces. The device distinguishes faeces from urine. The sensing technology can be easily inserted or woven into the manufacture of a standard incontinence pad which is then simply connected to a thin, lightweight, wallet-sized, re-chargeable wearable monitor. When a patient passes stool, the device promptly alerts a nursing station or caregiver’s mobile phone.’

Working with patients directly affected by Faecal Incontinence, their families and other stakeholders including nurses, care home staff and managers, our multi-disciplinary research team will use the NIHR funding to:

  • Refine our existing prototype sensor such that it can be readily integrated into a standard, disposable incontinence pad during manufacture.
  • Develop a thin, wallet-sized, flexible and re-usable wearable monitor with wireless connectivity to a mobile phone or centralised 'nursing base station'.

Andy went on to say,

‘Our proposition is simple; changing soiled pads 'on demand' will radically transform the dignity and care of individuals suffering faecal incontinence.’

Flo-Ox™ - A bedside air stream oxygen monitor for mechanical CPAP devices

April 2020

Flo-Ox™ - A bedside air stream oxygen monitor for mechanical CPAP devices

Flo-Ox™ is a bedside oxygen concentration monitor developed for use alongside the UCL-Ventura continuous Positive Airway Pressure (CPAP) device.

The Flo-Ox™ was developed in response to an emergency COVID-19 call by the UK’s National Health Service (NHS) for continuous Positive Airway Pressure (CPAP) devices and accompanying oxygen monitors. It uses a little bleed-off air from the CPAP patient circuit to continuously sample the oxygen concentration being delivered to the patient. The monitor features user-programmable MIN / MAX alarm thresholds to ensure that oxygen is delivered within set limits.

Flo-Ox™ connects to the patient breathing circuit via a gas sampling line and performs the following functions:

  • Displays the measured oxygen reading as large digits in units of % O2
  • Allows the user to change the Upper Alarm Limit in the range 18 – 100% O2
  • Allows the user to change the Lower Alarm Limit in the range 18 – 100% O2
  • Indicates the status of the oxygen reading in relation to the set alarm limits
  • Allows the user to mute the audio on the alarm for 30 seconds and/or clear the alarm when oxygen is back within set limits

CPAP devices provide respiratory support by applying mild and continuous positive air pressure to keep the airways open in patients who are able to breathe spontaneously, thereby helping them breathe and take up oxygen more easily.

Crucially, CPAP does not require patient sedation or intensive care and is a viable alternative to mechanical ventilation in the majority of patients requiring respiratory support. Its employment has been shown to reduce demand for intensive care beds and to allow mechanical ventilators to be reserved for the most critically ill patients.

While the Flo-Ox™ was developed specifically for the UCL-Ventura device it is a stand-alone oxygen monitor that is theoretically compatible with any CPAP device being used to treat patients with breathing difficulties at the hospital bedside.

Intended Use Statement:

The Flo-Ox™ is intended for the monitoring of the concentration of oxygen output from a mechanical CPAP device. It is intended to be used in the hospital environment in both general and critical/intensive care units. The Flo-Ox™ is not a life supporting device.

Regulatory Statement:

Flo-Ox™ was originally awarded a temporary UK MHRA waiver for patient use and has now received full CE mark approval.

WellBeing™ - A bladder tissue oxygen monitor

April 2019

WellBeing™ - A bladder tissue oxygen monitor

The WellBeing System is a clinical bladder tissue oxygen measuring device that samples the partial pressure of oxygen (ptO2) at the bladder wall.

Patients who are unwell or undergoing major surgery routinely have a Foley type bladder catheter inserted via the urethra in order to allow urine to be continuously drained from the bladder. The WellBeing System uses a specially developed version of the Foley urine drainage catheter to additionally facilitate the positioning of a small, flexible, optical oxygen sensor to make gentle contact with the bladder wall. Once the oxygen sensor is positioned against the bladder wall, the WellBeing System provides continuous monitoring of ptO2 from bladder wall tissue in units of kPa or mmHg.

WellBeing's patented technology provides a continuous assessment of local oxygen supply-demand balance, thus indicating tissue oxygen debt, a major determinant of Multiple Organ Failure (MOF).

Because global haemodynamic markers do not correlate well with microvascular function, WellBeing opens a new window of opportunity for patient resuscitation; based not simply on arterial pressure-based endpoints, but on crucially important organ tissue perfusion-based endpoints.

Oxford Optronix Ltd. has been actively developing the WellBeing System over the last decade. WellBeing’s optical oxygen sensing technology, electronic signal processing algorithms and sensor introducer/urinary drainage catheter are protected by a number of filed and granted world-wide patents.

WellBeing is now in a major, two-year clinical trial in the ITU at University College London Hospital (UCLH) funded jointly by the Department of Health and The Wellcome Trust. Entitled; ‘A single site observational study of tissue oxygen monitoring for detecting impending shock states in the critically ill and those undergoing high risk surgery utilizing the WellBeing system’, this ground-breaking clinical trial is being conducted under the auspices of Professor Meryn Singer1, Dr David Brealey2 and Dr Andrew Obeid3

1Mervyn Singer (Chief Investigator) MB, BSc, MD, FRCP(Lon), FRCP(Edin), FFICM is Professor of Intensive Care Medicine at University College London, an NIHR Senior Investigator and Chair of the International Sepsis Forum.

2David Brealey (Principal Investigator) PhD MRCP FRCA is Consultant in Anaesthesia and Critical Care at University College London Hospital.

3Andrew Obeid BSc, MSc, PhD is CEO of Oxford Optronix Ltd.