Reducing Harm In Ventilated Patients: First In-patient Evaluation Of A Smart Endotracheal Tube

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In health, people can keep their airway open and breathe naturally. Seriously ill or anaesthetised patients however cannot do this, so clinicians often use an endotracheal tube (ETT) in the trachea (windpipe) to maintain an open airway and allow air to be delivered to the lungs via a mechanical ventilator. 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. To minimise injury and illness, it is important that this pressure is balanced correctly to avoid leaks and to protect the lungs from contamination. Unfortunately, due to the need for routine pressure measurements, tracheal injuries and ventilator associated pneumonia are common.If the cuff pressure is too high this can cause injuries that range from moderate to severe sore throat in half of all patients after surgery (500,000 per year in the UK), to lifelong tracheal narrowing (Post Intubation Tracheal Stenosis, PITS) which occurs in around 2,000 patients per year in England. If the cuff pressure is too low this results in fluids leaking into the lungs which can lead to ventilator associated pneumonia (VAP). VAP affects as many as one in five people in intensive care, increases hospital stay by 6 days, costs the NHS £12,000 per episode and increases the likelihood of death. We aim to benefit intubated patients worldwide by creating a new medical device based on this world first technology.iTraXS (intra tracheal multiplexed sensing) is a new endotracheal tube which uses fine optical fibre sensors in the cuff. The sensors use light to measure the pressure and blood flow at the interface between the cuff and trachea. Maintaining the correct cuff pressure can help to reduce tracheal injury and ventilator associated pneumonia. The sensors measure vital signs such as heart rate and oxygen saturation. The sensors can also identify when the ETT is incorrectly placed in the oesophagus, a potentially fatal situation. We think iTraXS is capable of improving the everyday experience of surgery for patients worldwide and will significantly reduce the suffering caused by VAP or PITS Within this project we will conduct the first clinical evaluation of this new technology with 40 adult participants undergoing elective surgery.