The University of Nottingham, UK, has secured more than £800,000 (~€893,000) in funding from the Medical Research Council to accelerate development of the world's first optical fibre sensor-equipped endotracheal tube (iTraXS).
iTraXS aims to prevent pressure injury to the airway and to assist with monitoring vital signs.
Worldwide, approximately 120 million surgical and intensive care patients a year rely on Endotracheal tubes (ETTs). The tube has an inflatable, balloon-like cuff, which sits inside the trachea forming a gas-tight seal to prevent leaks of oxygen-rich air and maintain effective ventilation. The seal also protects the lungs from contamination by vomit or blood which can lead to ventilator-associated pneumonia (VAP).
At present there is no medical device on the market to accurately and safely measure and monitor the contact pressure of the inflated cuff and the blood flow in the tracheal lining (mucosa). iTraXS uses thin, flexible, optical fibre sensors incorporated into a standard disposable ETT, which is linked to an optoelectronic monitoring and display unit.
The device successfully monitors both the contact pressure and the blood supply at the cuff-trachea interface. The concept has won widespread support including an award from the Association of Anaesthetists of Great Britain and Ireland in 2018.
Steve Morgan, Professor of Biomedical Engineering and Co-Director at the Centre for Healthcare Technologies, said: “iTraXS demonstrates the potential of emerging optical sensor technology to enable real-time monitoring inside patients, providing previously unavailable data to aid clinical decision making and improving the surgical experience of patients worldwide.”
University of Nottingham researchers aim to develop regulatory compliant software and hardware and expand the number and functionality of sensors built into iTraXS. At the end of the current project the device will be ready for clinical trials and could be CE-marked and brought to market within three years.
ITraXS has been developed in partnership with P3 Medical Ltd, a Bristol-based manufacturer of endotracheal tubes and Nottingham University Hospitals NHS Trust (NUH).
Dr David Hewson, Consultant Anaesthetist at NUH and one of those involved in delivering the research, said, "This substantial award from the Medical Research Council means this innovative smart medical device is one step closer to being used in patients. This project is about new ways to monitor the health of patients in ICU and reduce their risk of pneumonia and damage to their trachea while on life support ventilators.”