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

在健康的情况下，人们可以保持呼吸道畅通，自然呼吸。然而，重病或麻醉的患者无法做到这一点，因此临床医生通常在气管（气管）中使用气管内导管（ETT）来维持开放的气道，并允许通过机械呼吸机将空气输送到肺部。将导管放入气道中，并在气管处对气囊（气囊）充气，以形成气体密封，从而使空气有效地输送到肺部。为了最大限度地减少伤害和疾病，正确平衡压力以避免泄漏并保护肺部免受污染非常重要。不幸的是，由于需要进行常规压力测量，气管损伤和呼吸机相关性肺炎很常见。如果袖带压力过高，可能会导致一半的手术后患者出现中度至重度咽喉痛的损伤（英国每年500，000例），至英国每年约2，000例患者发生的终身气管狭窄（插管后气管狭窄，PITS）。如果袖带压力太低，这会导致液体泄漏到肺部，这可能导致呼吸机相关性肺炎（VAP）。VAP影响了重症监护室中多达五分之一的人，增加了6天的住院时间，每次发作花费NHS 12，000英镑，并增加了死亡的可能性。我们的目标是通过创造一种基于这一世界首创技术的新医疗设备来造福全球插管患者。iTraXS（气管内多路复用传感）是一种新型气管内插管，在套囊中使用精细光纤传感器。传感器使用光来测量袖带和气管之间界面处的压力和血流。保持正确的袖带压力有助于减少气管损伤和呼吸机相关性肺炎。传感器测量生命体征，如心率和血氧饱和度。传感器还可以识别ETT何时被错误地放置在食管中，这是一种潜在的致命情况。我们认为iTraXS能够改善全球患者的日常手术体验，并将显著减少VAP或PITS造成的痛苦。在该项目中，我们将对40名接受择期手术的成人参与者进行这项新技术的首次临床评估。

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.