The University of Nottingham has secured £1.1 million in funding from the Medical Research Council to undertake human trials for the world's first optical fibre sensor-equipped endotracheal tube (iTraXS).
Seriously ill or anaesthetised patients are unable to breathe naturally, so clinicians often use endotracheal tubes (ETTs), which are placed in the trachea (windpipe) to maintain an open airway and allow the patient to breathe through a mechanical ventilator. To do this, the tube is placed into the airway and a cuff (balloon) is inflated at the trachea to create a gas seal that allows air to be delivered to the lungs effectively. However, incorrect cuff inflation pressure can cause two main problems.
If pressure is too low, it can risk fluid getting past the cuff and causing ventilator-associate pneumonia (VAP). VAP increases the likelihood of death, affecting up to 20% of people in intensive care, and costs the NHS between £10,000 and £20,000 per patient. Conversely, if pressure is too high it can cause a pressure injury in the trachea, ranging from moderate to severe sore throats through to permanent scarring and narrowing of the windpipe.
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.
The concept has already received widespread support from the industry, including an award from the Association of Anaesthetists of Great Britain and Ireland in 2018.
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.
David continued: "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."
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.
Dr Andrew Norris, Anaesthetist, Honorary Associate Professor at the University of Nottingham and now based at King Abdullah bin Abdulaziz University Hospital, said: "This project has been a collaborative effort since we received the initial NIHR funding in 2014.2
Now we're at the point of beginning to coordinate in-person trials, we're engaging with key opinion leaders to amplify our research. Once the trial is complete, we aim to get the tube CE-marked so that it can be brought to market in the near future.
To read the latest research paper published about iTraXS in Biomedical Optics Express, please click here.
