Title: Safe and Effective Above Cuff Tracheostomy Vocalisation in Tracheostomised Patients: A device development study. (SEA CtV)
Funder: Department of Health and Social Care

Abstract: Tracheostomies are 'artificial airways' most commonly used in the Intensive Care Unit (ICU) for patients requiring prolonged mechanical ventilatory support, or for patients with altered or dysfunctional upper airway anatomy. Around 20,000 new tracheostomies are inserted in the UK annually, with around two-thirds in ICU patients and the rest in head and neck surgical practice. Awake, tracheostomised patients often cannot vocalise as the tubes have a balloon, or cuff, which 'seals off' the upper airway to prevent aspiration and/or facilitate ventilation. Alternative communication strategies are complicated by weakness, leading to frustration, anxiety and disengagement from care and rehabilitation. Furthermore, laryngeal disuse atrophy makes swallowing, coughing, talking and liberation from the ventilator more difficult, and the process takes longer. Our pilot research demonstrated that early restoration of trans-laryngeal airflow had a positive effect on laryngeal function, as well as giving back patients the gift of speech. This project aims to get patients with new tracheostomies talking earlier in their treatment, by developing a safe and effective system to deliver trans-laryngeal gas flows 'above the cuff' of the tube, and out via the mouth. Above Cuff Vocalisation (ACV) is currently possible using basic delivery of unregulated, continuous flow, dry gas. We hypothesise that by delivering ACV more safely, using heated, humidified and timed gas flows, this will allow greater tolerability and therefore prolonged use of ACV, leading to demonstrable improvements in vocalisation and laryngeal function. Our primary research question is; Can we design and develop a device to deliver ACV that is safe, well tolerated and effective at producing a voice in tracheostomised patients in the Intensive Care Unit? We also wish to evaluate whether more effective delivery of ACV has a significant impact on laryngeal function and recovery following new tracheostomy in ICU patients. We aim to address these questions in four conceptualised phases addressing safety, tolerability, effectiveness and the impact on the patient journey. The first two years of this project involves designing and testing a prototype with University Engineers and external design expertise to safely deliver warm, moist gas for ACV, with delivery timed for when patients want to speak, and ensuring patient comfort. Following initial bench and clinical safety testing, a 2x2 factorial design trial will assess device performance, rated subjectively by patients, objectively by multidisciplinary bedside staff, and invasively by assessing laryngeal function in real time using Fibreoptic Endoscopic Evaluation of Swallow (FEES) and determining sensory stimulation thresholds. The third year involves a randomised controlled trial of the final prototype, building the technical file for future CE marking or follow on investment, and strengthening the case for clinical utility and efficacy. Our intended output is to develop and clinically validate a prototype medical device able to safely and effectively deliver ACV, helping patients to communicate and enhancing laryngeal rehabilitation. Such a device could benefit all patients managed with a tracheostomy worldwide, whilst generating new knowledge and intellectual property for the NHS and Engineering Sciences, disseminated widely through our global clinical, scientific and patient & family group connections.

Lay abstract: Tracheostomies are small plastic tubes inserted into the neck. These 'artificial airways' are used most commonly in the Intensive Care Unit (ICU) for patients who are weak, or who need breathing support from a ventilator. Some Head & Neck surgical operations also need a tracheostomy. Around 20,000 new tracheostomies are inserted in the UK each year, with around two-thirds in ICU patients. Patients tell us when they wake up with a tracheostomy, the worst thing is not being able to speak. Tubes have a balloon or cuff which 'seals off' the upper airway (nose and mouth) meaning that gas breathed in and out does not flow through the larynx (voice-box). Patients can be fully awake and yet unable to speak, lasting for days or weeks. Other communication is made worse by weakness, making it hard for patients to tell staff or loved ones how they are feeling, causing stress and worry and makes caring for patients more difficult. Our research shows that if the voice-box is not used for several days, the muscles become weak. As patients start to recover, the weakened voice-box makes swallowing, coughing, talking and getting off the ventilator more difficult and the process takes longer. Our research demonstrated that making the voice-box work by getting patents talking earlier had a positive effect on voice-box function, as well as giving patients back the gift of speech. Our project aims to get patients with new tracheostomies talking earlier in their treatment, by developing a safe and effective system to deliver gas flows 'above the cuff' of the tube, and out of the mouth via the voice-box. We call this technique 'Above Cuff Vocalisation' or ACV. We can only currently deliver ACV using a continuous flow of cold, dry gas, without safety features. The first two years of this project involves designing and testing a new product to safely deliver warm, moist gas for ACV, delivered when the patient wants to speak, and ensuring patient comfort. The final year of the project involves conducting a study where we use the device we have developed and compare it to tracheostomy patients who do not use it. We will work with patients, doctors, nurses and speech and language therapists to record the effect that our device has on: Talking: can patients talk earlier and with a better voice? Eating: can patients swallow earlier? Stress and worry Time spent in ICU or in hospital By the end of this project, we aim to have developed a carefully tested (clinically validated) prototype medical device that is able to safely and effectively deliver ACV, helping patients to communicate and speeding up their recovery. Thank you for considering our proposal.

Research activity codes: 6.3 MEDICAL DEVICES;5.3 MEDICAL DEVICES
Health categories: RESPIRATORY