Guided Insertion Of Tracheostomy Tubes (GIFT): An Early Feasibility Study

The goal of this clinical trial is to assess the safety, accuracy and practicality of a new guidance system called Guided Insertion for Tracheostomy (GIFT). The study will involve adults in intensive care who need a tracheostomy as part of their usual treatment. A tracheostomy is a procedure that creates an opening in the front of the neck to place a breathing tube into the windpipe (trachea). It is commonly performed in intensive care to help people who need prolonged support from a breathing machine. During the procedure, doctors insert a needle into the windpipe before creating the opening for the breathing tube. Choosing the correct position for the needle is important to avoid injury to nearby structures. GIFT is a new system that uses electromagnetic technology to help doctors guide the needle towards the intended position. Small sensors allow the system to display the position of the needle in relation to the windpipe in real time. The aim is to help doctors place the needle more accurately and potentially make the procedure safer. \*\*The main questions this study aims to answer are:\*\* * Does the System work in the ICU (Is it feasible) * How accurately can doctors position the needle using GIFT? * Can GIFT be used safely during tracheostomy procedures in intensive care? * Does GIFT work reliably during routine clinical procedures? * Do healthcare professionals find GIFT practical and easy to use? Participants will: * Undergo a tracheostomy as part of their usual intensive care treatment. * Have the GIFT system used to guide needle placement during the procedure, alongside the usual camera guidance used to view the inside of the windpipe. * Have information about the procedure, any complications and their subsequent recovery collected by the research team. The study will involve approximately 30-40 participants at Manchester University NHS Foundation Trust. Our aim is to assess the feasibility of the prototype medical device to guide trained clinicians in bronchoscopy-assisted percutaneous tracheostomy needle insertion, and its integration into the existing tracheostomy workflows in the ICU. All participants will receive a tracheostomy because their clinical team considers it necessary. The decision to perform the procedure will be made independently of the research. Researchers will explore a number of safety, usability and performance (accuracy) to evaluate the feasibility of the System. The investigators will measure how close the needle is placed to the intended target and record any problems associated with the procedure or the GIFT system. Investigators will also collect information about participants' recovery in intensive care. Healthcare professionals involved in the procedures will be invited to complete questionnaires about their experience of using GIFT. This is an early clinical evaluation of a new medical device. The study is designed to establish whether GIFT can be used accurately, safely and practically in intensive care. It is not designed to prove that GIFT is safer than current tracheostomy techniques. The findings will help researchers decide whether GIFT should be evaluated in larger clinical trials.

Inclusion Criteria: * Patients managed in one of the critical care units at MFT who require a tracheostomy in the opinion of the parent medical team * Adult patients (age greater-than-or-equal-to 18 years) * Patients are suitable for bedside ICU PDT in the opinion of the parent medical team. Typically, the parent team will consider suitability for ICU PDT based on the following criteria: * No anatomical abnormalities identified * No anterior neck blood vessels identified on pre-procedural ultrasound scan of the neck * Patients are considered clinically stable enough to tolerate the PDT procedure * Patients are considered clinically stable enough to tolerate the bronchoscopy associated with the PDT procedure Exclusion Criteria: * Patients who are not managed in one of the critical care units at MFT * GIFT System contraindications: * An implantable medical device that may be cause interference with GIFT's electromagnetic field, or which GIFT may affect. Practically, these are temporary or permanent pacemakers, implantable cardiac defibrillators, neural stimulators (deep brain, spinal, vagal, sacral), implantable drug delivery systems, cochlear implants)\* * Any clinical conditions that would preclude an MRI scan (based on the presence of a magnetic field) * Patients who have a contra-indication to PDT in the opinion of the parent medical team. Typically, the parent team will consider contra-indications for ICU PDT based on the following criteria: * Anatomical abnormalities identified * Anterior neck blood vessels identified on pre-procedural ultrasound scan of the neck * Patients are not considered clinically stable enough to tolerate the PDT procedure * Patients are not considered clinically stable enough to tolerate the bronchoscopy associated with the PDT procedure