Physiological sensing capabilities of a novel IntraTRAcheal multipleXed Sensing tube: a pilot clinical trial with feasibility assessment (iTraXS 1)
Surgery
All participants will undergo an identical trial treatment regime. There are no group-specific allocations or treatments. All participants will be anaesthetised by anaesthetists who are members of their usual NHS care team. Participants will undergo surgery as part of their usual NHS care. All treating anaesthetists must undergo trial training provided by designated trial trainers who can demonstrate placement of the iTraXS tube. Training by participating anaesthetists will be documented in training logs. As per routine clinical practice: following pre-oxygenation of the lungs for 3 minutes via non-invasive facemask, induction of general anaesthesia will be performed by target-controlled intravenous infusion of agents of general anaesthesia. The choice and dose of agents will be at the discretion of the treating usual clinical anaesthetist. After administration of a non-depolarising neuromuscular blocking drug (rocuronium 0.5 mg per kg) and confirmation of loss of muscle tone by qualitative neuromuscular monitoring device, visualisation of the glottis will be undertaken using a videolaryngoscope (Glidescope system). The iTraXS tube will then be placed into the trachea instead of a conventional NHS tracheal tube. As per routine practice tube placement will be confirmed with exhaled carbon dioxide monitoring and positive pressure ventilation commenced. Data collection from the tracheal sensors will commence from entry of the tube into the trachea and continue until removal of the tube from the patient at the end of surgery and general anaesthesia. Following successful tracheal intubation, a second iTraXS device will be placed into the upper oesophagus to obtain oesophageal signals. This device will not be connected to a mechanical ventilator. Data collection will commence from entry of that tube into the oesophagus. After acquisition of data from the oesophagus, this tube will be removed, leaving only the tracheal tube in place for the rest of anaesthesia and surge
1. Age 18 - 70 years 2. Undergoing elective surgery with planned tracheal intubation and arterial catheterisation as part of routine NHS clinical care 3. Able to provide informed written consent
1. Known or predicted difficult facemask ventilation or tracheal intubation 2. Previous and planned laryngeal, tracheal or oesophageal surgery 3. History of dysphagia or achalasia 4. History of uncontrolled gastro-oesophageal reflux or known hiatus hernia 5. History of pharyngeal pouch 6. Risk of pulmonary aspiration of gastric contents necessitating awake or rapid sequence tracheal intubation 7. Pregnancy