MICA: iTraXS (intra Tracheal Multiplexed Sensing): an optical sensor equipped endotracheal tube

MICA：iTraXS（气管内多重传感）：配备气管插管的光学传感器

• 批准号: MR/T025638/1
• 负责人: Stephen Morgan
• 金额: $ 108.32万
• 依托单位: University of Nottingham
• 依托单位国家: 英国
• 项目类别: Research Grant
• 财政年份: 2020
• 资助国家: 英国
• 起止时间: 2020 至 无数据
• 项目状态: 已结题
• 来源: https://gtr.ukri.org/projects?ref=MR%2FT025638%2F1
• 关键词: MICA; iTraXS; intra; Tracheal; Multiplexed

In health, people keep their airway clear by coughing and keeping a resting "tone" in the muscles of the throat and tongue. Seriously ill or anaesthetized patients however cannot do this, so clinicians often use an endotracheal tube (ETT) in the trachea (windpipe) to maintain an open airway. The tube has an inflatable "cuff", which sits inside the trachea and forms a gas-tight seal preventing gas leaks and protecting the lungs from soiling by vomit or blood which can lead to ventilator associated pneumonia. The cellular lining (mucosa) of the trachea is easily injured when pressure from the cuff squeezes oxygen carrying blood out of the tissues. To minimize injury, it is important that this pressure is kept at the minimum necessary to avoid leaks and to protect the lungs from contamination. Unfortunately, clinical staff don't routinely measure pressure, and dangerously high readings are commonplace, resulting in a range of tracheal injuries. Injuries 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 2000 patients per year in England. Our survey of PITS patients revealed a pattern of delayed diagnosis and significantly reduced physical activity from breathlessness.Our group recently developed a new prototype tube (iTraXS- intra Tracheal Multiplexed Sensing) which uses fine optical fibre sensors in the cuff. In addition to blood flow, oxygenation and temperature measurement, contact pressure with the tracheal wall is measured by the change in wavelength (colour) of light reflected from the sensor. This enables the cuff to be inflated to the most appropriate pressure in order to achieve a gas seal but not to occlude blood flow in the mucosa. This project aims to extend the sensing ability and make clinically compliant versions of our laboratory hardware and software which measure the wavelength changes. We will test the new system in preclinical studies at the University of Nottingham. At the end of this project the device will be ready for clinical trials. We think iTraXS is capable of improving the everyday experience of surgery for patients worldwide and significantly reduce the suffering and costs associated with PITS at low cost to purchasers. In addition, we think that iTraXS will demonstrate the potential of emerging optical sensor technology to enable sensing of the internal environment of patients in real time, providing previously unavailable data to aid clinical decision making. In addition to standard academic dissemination, our partners P3 Medical and Gill Research and Development will provide valuable manufacturing experience and trade exposure. The iTraXS prototype was runner up at the 2018 Innovation Awards of the Association of Anaesthetists of Great Britain and Ireland, which we expect will help us with industry and clinician awareness. Activities conducted in this project such as end user engagement, health economic modelling and market research will help to support the business case.

在健康的情况下，人们通过咳嗽和保持喉咙和舌头肌肉的静止“音调”来保持呼吸道畅通。然而，重病或麻醉的患者不能这样做，因此临床医生经常在气管（气管）中使用气管内插管（ETT）来维持气道开放。气管内有一个可充气的“袖口”，形成气密密封，防止气体泄漏，保护肺部不被呕吐物或血液污染，从而导致呼吸机相关的肺炎。当来自袖带的压力将携带氧气的血液挤出组织时，气管的细胞内膜（粘膜）很容易受伤。为了尽量减少伤害，重要的是要将压力保持在最低限度，以避免泄漏和保护肺部免受污染。不幸的是，临床工作人员不定期测量血压，危险的高读数是司空见惯的，导致一系列气管损伤。一半的术后患者（英国每年有50万例）的损伤范围从中度到重度喉咙痛到终身气管狭窄（插管后气管狭窄- PITS），在英国每年约有2000例患者发生。我们对pit患者的调查揭示了一种延迟诊断的模式，并因呼吸困难而显著减少了身体活动。我们的团队最近开发了一种新的原型管（iTraXS-气管内多路复用传感），它在袖带中使用了精细的光纤传感器。除了测量血流、氧合和温度外，还可以通过传感器反射的光的波长（颜色）变化来测量与气管壁的接触压力。这使袖带能够膨胀到最合适的压力，以实现气体密封，但不会阻塞粘膜中的血液流动。本项目旨在扩展传感能力，使我们的实验室测量波长变化的硬件和软件符合临床要求。我们将在诺丁汉大学的临床前研究中测试新系统。在这个项目结束时，该设备将准备好进行临床试验。我们认为iTraXS能够改善全球患者的日常手术体验，并以较低的成本显著减少与pit相关的痛苦和成本。此外，我们认为iTraXS将展示新兴光学传感器技术的潜力，能够实时感知患者的内部环境，提供以前无法获得的数据，以帮助临床决策。除了标准的学术传播外，我们的合作伙伴P3医疗和Gill研发将提供宝贵的制造经验和贸易机会。iTraXS原型在英国和爱尔兰麻醉师协会的2018年创新奖中获得亚军，我们希望这将有助于我们提高行业和临床医生的意识。在这个项目中开展的活动，如终端用户参与、卫生经济建模和市场研究，将有助于支持商业案例。

项目成果

Intra-tracheal multiplexed sensing of contact pressure and perfusion.

• DOI: 10.1364/boe.442165
• 发表时间: 2022-01-01
• 期刊: Biomedical optics express
• 影响因子: 3.4
• 作者: Correia R;Gadsby B;Korposh S;Norris AM;Hayes-Gill BR;Sinha R;Hardman JG;Gardner DS;Talbot S;Harvey D;McGlashan J;Morgan SP
• 通讯作者: Morgan SP