Title: A novel endotracheal tube to reduce incidence of post-intubation stenosis and ventilator associated pneumonia in children and adults requiring artificial ventilation.
Funder: Department of Health (England)

Abstract: The project is planned in 5 distinct phases of which the first (described as phase 0) is already complete Phase 0: Proof of concept Objectives (all complete) Project outline. Assemble research team Construction of first prototype and data gathering in volunteers (Appendix) Significant PPI (Appendix) IP searches Market research (Apppendix) Phase 1: IP, system refinement and human evaluation (ethics approval) (0-9 months) Objectives Secure IP. We Have made disclosures via the Technology Transfer Office of the University of Nottingham, and, once funding is secure, we intend to file for patents. Finalisation of optical configuration to optimise the choice of fibres, frequencies, modalities, and signal return Refining pressure measurement. In this project we are exploring novel use of optical fibres to measure pressures inside the cuff of an endotracheal tube in addition to contact pressures between the tube cuff and the tracheal wall. Investigation of modulation of air pressure. This innovative aspect involves small modulation of the cuff pressure in order to monitor the capillary refill rate of the mucosal circulation. We believe this also has the potential for a therapeutic effect via reduction in ischaemic injury Exploration of manufacturing options. The Medical Engineering Unit and P3 Medical will manufacture an advanced prototype. Develop hardware to interface with disposable device, display the output, and allow user interaction. Design our protocol for evaluation in a small volunteer group Obtain ethics approval The study will be conducted through the University, and ethical approval will be sought through that route, informed by engagement of a combined clinician and lay focus group. Patients and NHS resources are not required Deliverables: 1.1 Patent filed, 1.2 optimum configuration specified, 1.3 sensors bonded to tube 1.4 interfacing hardware developed 1.5 Ethics approval obtained Risks: We foresee no significant risks up to this point. During phase 0 a minimum acceptable level of performance has been surpassed and we are seeking to improve this performance. Phase 2: Prototype manufacture (10-12 months) Objectives. Manufacture of high fidelity prototype for human tracheal use. MEU and P3 Medical will cooperate to establish ease of production and define costs, manufacturing technique and address regulatory issues. Deliverables: 2.1 Confirmation of engineering feasibility, at appropriate cost ( Risks: Low. The Engineering team has extensive experience of manufacture and compliance with medical device regulation. Phase 3: Small-scale evaluation and initial dissemination of findings (13-16 months) Objectives Conduct evaluation in ~10 healthy adult volunteers to confirm Demonstrate ability to reproduce monitoring of the microcirculation, cuff pressure and contact pressures in the human trachea previously demonstrated using oral mucosa (Phase 0) Demonstrate usability Collect initial safety data Deliverables: 3.1 Simultaneous recordings of cuff pressure, contact pressure and capillary refill rate in 10 volunteers, 3.2 Preparation of results for presentation in meetings and publication in high impact academic conferences and journals Risks: Medium. This will be the first volunteer study and there may be potential issues with fibre positioning, signal to noise ratio and motion artefacts. We will produce tubes with different sensor positions and will allow sufficient resource for a further design iteration during phases 3 and 4. Phase 4: Planning for licensing, marketing and follow on products (17-18 months) Objectives Develop funding application for larger clinical study (NIHR or Technology Strategy Board (Biocatalyst)) Agree arrangements for production and marketing of initial product(s) with P3 Medical. Identify areas of improvement for next generation as well as other airway devices including tracheostomy tubes and supraglottic airway devices. Deliverables: 4.1 Future funding application developed 4.2 Licensing agreement in place Risks: Medium. These are contingent on performance of the device in phase 3.


Research activity codes: 5.3 MEDICAL DEVICES
Health categories: RESPIRATORY