The iTraXS device has been developed in a collaboration involving Nottingham University, which has secured £1.1m in funding from the Medical Research Council to undertake the trials.
An option for patients who are unable to breathe naturally is the insertion of an endotracheal tube (ETT), which is placed in the trachea (windpipe) to maintain an open airway and allow the patient to breathe through a mechanical ventilator. The tube is placed into the airway and a cuff is inflated at the trachea to create a seal that allows air to be delivered to the lungs.
Incorrect cuff inflation pressure can cause two problems: if pressure is too low, it can risk fluid getting past the cuff and causing ventilator-associate pneumonia (VAP), but if the pressure is too high it can cause a pressure injury in the trachea. This can range from moderate to severe sore throats through to permanent scarring and narrowing of the windpipe.
In a statement, Professor Steve Morgan, co-director of the Centre for Healthcare Technologies and Professor of Biomedical Engineering at the university, said: “Currently, there’s no medical device on the market that can safely and accurately measure and monitor the contact pressure of the cuff and the blood flow in the tracheal lining.
“iTraXS aims to solve this real-world challenge by preventing pressure injuries to the airway and assisting with monitoring these vital signs. The sensors can identify when the ETT has been incorrectly placed, which if undetected could be potentially fatal. This is an incredibly exciting time for the project as we’re now able to turn our research into reality as we prepare to conduct the first clinical evaluation in 40 adult participants undergoing planned surgery next year.”
iTraXS has been developed in collaboration with P3 Medical Ltd, a Bristol-based manufacturer of endotracheal tubes, and Nottingham University Hospitals NHS Trust (NUH) as well as CHEATA, Bluefrog Design Ltd and Derby Clinical Trials Support Unit.
David Hewson, Associate Professor of Anaesthesia and Perioperative Medicine, Faculty of Medicine and Health Sciences at Nottingham University, said: “There is a plethora of advantages to introducing technology like this. Not only will it aid those already in hospital, but it could also help when it comes to pre-hospital conditions. For example, it could remove the need for other devices such as oxygen saturation monitors attached to the finger, which can be inconvenient when travelling in an ambulance as well as inaccurate if a patient has low blood pressure. These technologies have the potential to be a real step change in the way we will be able to monitor patients moving forwards.”
A paper detailing the iTraXS has been published in Biomedical Optics Express.