Title: The ACoUSTiC study – Exploring the potential benefits of Above CUff VocaliSation in TraCheostomy: communication, swallowing, decannulation and cost savings
Funder: Health Education England

Abstract: Background: Approximately 12,000 patients per year in the UK (excluding Scotland) have a tracheostomy inserted to provide respiratory support1. These tubes prevent vocalisation2 which results in difficulty communication which often leads to frustration for the patient3. It can also cause difficulty swallowing saliva and oral intake4 which can result in higher risk of ventilator associated pneumonia (VAP)5. Patients who develop VAP have increased intensive care unit (ICU) and hospital length of stay6 resulting in greater NHS treatment costs7. Patients who receive tracheostomy generally have more severe underlying disease and a high risk of mortality during their stay which continues to rise post-discharge8. VAP carries a 13% mortality rate which contributes to this high mortality rate9. Tracheostomised patients are also likely to have reduced short- and long-term quality of life10.Tracheostomy weaning and decannulation, or tracheostomy removal, is complex process that varies widely both within and between hospitals in the UK and internationally1115. Impaired swallowing, and difficulties swallowing saliva because of the tracheostomy, can result in delayed weaning and decannulation and consequently increased length of stay in ICU and in hospital16,17.Recent research has investigated utilising the sub-glottic port of the tracheostomy tube to deliver an airflow into the trachea, and through the larynx, to enable vocalisation and improve communication in this patient group 18. This technique has been termed Above Cuff Vocalisation (ACV). As well as improving communication function, this technique has also been shown to improve swallow frequency and reduce the amounts of aspirated saliva18,19. These research findings suggest that regular use of ACV may help to bring about various potential benefits for patients and the NHS.Hypothesis: Regular use of ACV can result in improved swallow function, improved ability to communicate, reduced length of time to decannulation, reduced length of stay and cost savings, compared with usual care, indicating the need for a full definitive randomised controlled trial (RCT).Aims: To investigate current ACV practice and current tracheostomy weaning practice in the UK and internationally To evaluate current opinions of ACV: the patient, carers and healthcare professionals. To determine the feasibility of conducting a full definitive RCT which will investigate whether ACV results in improvements in swallowing, communication, tracheostomy weaning and cost savings Methods: Qualitative study using an online questionnaire distributed to multi-disciplinary professionals internationally to explore current ACV and tracheostomy weaning practice. Qualitative study utilising focus groups to investigate the opinions of patients, carers and multi-disciplinary professionals regarding ACV. Single-centre, prospective randomised controlled feasibility study with an exploratory micro-costing and time in motion study to determine the feasibility of conducting a definitive RCT. Potential benefits: Improved quality of life for patients Improved communication and swallowing function Earlier commencement of oral intake Earlier decannulation Earlier discharge from ICU and hospital Reduced NHS costs by reducing length of stay and reducing pneumonia rates

Lay abstract: Background: Patients that need to be on a machine to help them breathe often require a breathing tube. A tracheostomy tube is a type of breathing tube that is inserted through the front of the neck, into the windpipe. Approximately 12,000 patients per year in the UK (excluding Scotland) have a tracheostomy tube inserted. Patients with tracheostomy are at high risk of chest infection which can be a serious complication, leading to a longer stay in the intensive care unit, longer hospital stay, and in the worst case prevent recovery altogether.Around the outside of a tracheostomy tube is a soft inflatable cuff which helps prevent saliva from trickling down from the mouth into the windpipe and lungs. The down side of this cuff is that the individual is unable to speak, because when they breathe out, air does not pass through the voice box (larynx). Individuals can mouth words, but not make a sound; this means it can be difficult for them to make themselves understood, which can be distressing and very frustrating. The absence of airflow through the throat can also affect sensation. This may lead to difficulties swallowing saliva, food and drink. Swallowing difficulties can also result in chest infections, and further prolong the need for the tracheostomy tube. Some tracheostomy tubes are specially adapted to allow saliva that has collected in the throat above the cuff to be sucked out with a syringe; this can help prevent chest infection. Using this special type of tracheostomy tube, air can be blown into the windpipe, and up through the voice box, allowing the voice to return. This technique of blowing air into the throat is called Above Cuff Vocalisation (ACV).Recent research has shown that as well as enabling speech and communication, this technique may lead to improved swallowing. These findings suggest regular use of ACV could benefit many more patients than at present.Clinical Question: Does the regular use of ACV (blowing air into the throat) in patients with a tracheostomy tube lead to improved swallowing, earlier eating and drinking, better communication, earlier tracheostomy removal, earlier discharge from intensive care or the hospital and cost savings for the NHS?What we plan to do: This research is made up of three work streams: To use questionnaires to find out whether patients in intensive care units in the UK, and internationally, are receiving ACV and to find out more about how it is being used, including differences in processes for tracheostomy tube removal. To find out more about what patients, families and clinicians think about ACV, by carrying out focus groups to discuss their experiences. Work streams 1 and 2 will be used to help to develop an ACV intervention programme. This intervention will then be compared with usual tracheostomy care to see if patients who have ACV have better swallowing, communication and earlier tracheostomy removal. We will also look at the ACV intervention impact on NHS costs. This work stream will help us to determine whether a larger trial is feasible to answer the clinical question definitively. Patient, Carer and Public Involvement (PCPI): Patients and carers have been involved in the development of this research proposal and application. Two patients discussed their experience of having a tracheostomy in critical care and made comments on the research proposal. One patient with a tracheostomy who received ACV provided feedback on the intervention and the assessment procedure. This feedback has resulted in a change to the intervention protocol to improve patient comfort and tolerability. Funding for PCPI has been obtained from the Research Design Service Yorkshire and the Humber; this will enable a PCPI session to take place to obtain further feedback on the research proposal. It will also enable the formation of an ongoing PCPI steering group for the research in line with the INVOLVE guidelines. This steering group will provide input into the ongoing modification of the research proposal, and will also review all questionnaires, patient information and any reports targeted towards patients or the public. The group will help design the strategy for dissemination of research findings. Two of the PCPI steering group members will be invited to form part of the research advisory group.Dissemination: Dissemination of research findings will occur via publication in peer reviewed journals and profession specific publications and by presentation at national and international conferences. Research will also be disseminated to patients and the public using written summaries, presentations and via social media.

Research activity codes: 6.3 MEDICAL DEVICES
Health categories: RESPIRATORY