Award Title: A feasibility study examining the use of Mechanical Insufflation-Exsufflation to prevent extubation failure in adult intensive care (The MERIT study)
Funder: Health Education England

Abstract: BackgroundIn the United Kingdom approximately 230,000 adults are admitted to intensive care unit (ITU) each year (ICNARC, 2016) many requiring respiratory support (40-50%), commonly invasive ventilation (40.5%) (ICNARC 2015-16). Most adults successfully extubate in less than 5 days (mean ITU stay 4.8 days) however, 10-40% fail extubation (defined as requiring re-intubation within 48 hours) (ICNARC 2015-2016; Boles et al., 2007; Salam et al., 2004; Glover and Glossop, 2017; Terzi et al., 2018).Extubation failure causes significant problems, which can be associated with a failure to cough effectively. Respiratory physiotherapists use a number of treatment techniques to aid secretion clearance and support coughing; one such device is the Mechanical Insufflation-Exsufflation (MI-E). If this device can improve secretion clearance, used as part of treatment, it may reduce extubation failure. Aims and objectivesTo complete a feasibility study to determine whether it is possible to conduct a larger randomised controlled trial, of implementing MI-E as part of a weaning protocol in an adult ITU setting. MethodsPhase 1 (Year 1): A systematic review of the literature of mechanical insufflation-exsufflation as an airway clearance and/or cough augmentation technique in adult (>18 years) patients. Following up from my recent UK survey, I will explore UK physiotherapists' perceptions and views around current MI-E use within ITU, through semi-structured interviews. Phase 2 (Year 2): A pilot randomised controlled trial feasibility study (n=50) in a single large adult ITU will be undertaken. The study will determine whether it is possible to undertake a larger UK trial, including our ability to recruit and follow-up patients, optimal outcomes and the measurement of these. It will also establish the safety of MI-E in the ITU population. Phase 3 (Year 2 - midyear 3): Concurrently, a qualitative exploration of physiotherapists, patient and family experiences of the MI-E device in an ITU setting and any trial issues that were encountered. This will be by semi-structured interviews. A focus group of adult ITU healthcare professionals will occur to gain further perspective on study findings. Phase 4 (Mid-Year 3)To analyze, write up and actively disseminate study findings. The study will provide information on the safety and feasibility of using MI-E in an ITU population. It will also inform development of a training package tailored to meet the needs of the population (adult ITU physiotherapists) to use the device with both intubated and extubated patients. In addition to conference presentation and publications, dissemination will be achieved with the aid of a study website and Twitter account which will optimize engagement with patients, clinicians and key stakeholders throughout the study.

Lay Abstract: BackgroundThere are about 230,000 adult intensive care (ITU) admissions each year. Many of these patients require breathing support from a machine and breathing tube. Most adults are successfully removed from the breathing machine (extubation). However 10-40% of patients are unable to breathe by themselves once the tube has been removed and it needs to be put back in. One of the main reasons for this is because the patients are unable to cough well enough to clear mucus from their airway.Having to have the breathing tube put back in leads to worse outcomes for the patient, including prolonging their length of hospital stay and increasing their risk of death.To help with successful extubation, physiotherapists can use a device to help patients cough and clear phlegm from their lungs. The cough device works by blowing air into the patients lungs followed by quickly sucking it out. This device can be used before and after extubation. The cough device has only recently been used in the ITU setting and there are no studies exploring patients and/or healthcare professional's experiences of its use. AimsThe aim of this research is to find out if it is possible to carry out a large study to see whether using a cough device in ITU can help patients be successfully removed from breathing support. Design and methodsThere will be 4 stages:1-Year 1. A detailed review of published work examining the role of the cough device to help patients cough and clear secretions. Interviews with ITU clinicians to explore their thoughts about using the MI-E device with ITU patients.2-Year 2. A small (feasibility) study of 50 patients to see if it is possible to carry out a larger trial of the cough device. The study will tell us whether it is possible to recruit patients and whether they remain in the study. It will also look at the safety of the cough device (most existing safety data is from other hospital settings).Permission (consent) for the study will need to be from family members as patients will still be using the breathing machine when they join the study. Patients will be asked for consent for ongoing study participation once they are able.3- Mid year 2 - mid year 3. Interviews with some of the patients and clinicians involved in the feasibility study will seek their experiences of using the cough device. Separate patient consent will be sought for this. Physiotherapists will be specifically approached for inclusion. Findings will be discussed with groups of professionals from other hospitals to inform future work.4- Mid year 3. Completion of data analysis, write up and dissemination. PPIPatients, carers and a patient support charity 'ICU Steps' have been actively involved in the development of this application through a PPI meeting, informal discussions and reading the plain English summary. The chosen methods reflect these discussions. ICU Steps have agreed to contact patients who have been on ITU and have used a breathing machine to identify at least two people to join the study advisory group. As the study progresses, their views will continue to be sought. DisseminationThere will be a study specific website and social media page. Findings will be submitted to academic journals and professional conferences. ICU Steps have agreed to help share study findings at their regional meetings, and on their website. The patient partners will help to ensure that the findings are accessible to patients. Findings will also be shared with healthcare professionals through newsletters, website articles, presentations at relevant short courses and conferences.

Research Activity Codes: 6.3 MEDICAL DEVICES
Health Categories: GENERIC HEALTH RELEVANCE