The clinical and cost effectiveness of advanced airways protection device versus conventional endotracheal tubes in Intensive care unit patients requiring mechanical ventilation: a multicentre, pragmatic randomised clinical trial.

RESEARCH QUESTION: In mechanically ventilated adults on intensive care units (ICU), does an advanced airways protection device reduce the duration of invasive mechanical ventilation and is it cost effective? BACKGROUND: In the UK, 184,000 patients are admitted to NHS ICUs annually, of which one-third require invasive mechanical ventilation. Patients receiving invasive mechanical ventilation are at high-risk of developing a ventilator associated pneumonia (VAP), which is associated with prolonged ventilation and death. New tracheal tube devices have been developed which may reduce the risk of VAP. NICE have identified the urgent need for research to evaluate the clinical and cost-effectiveness of these advanced airway devices in the NHS AIM: To conduct a multi-centre, pragmatic, individually randomised, open-label, parallel group trial, and economic evaluation to determine the clinical- and cost-effectiveness of an advanced airways protection device , compared with conventional endotracheal tube (with or without basic subglottic suction and standard cuff) in hospitalised patients requiring mechanical ventilation. OBJECTIVES: (1) Conduct an internal pilot study to confirm the feasibility of the large-scale multi-centre trial; (2) Determine the clinical effectiveness of an advanced airways protection device in ICU patients requiring mechanical ventilation. (3) Through an integrated economic evaluation, determine the benefits and overall cost-effectiveness of an advanced airways device. METHODS: Setting: At least 44 NHS adult ICU centres, including geographical areas with high disease burden to maximise generalisability across the NHS. Randomisation: Allocation concealed, randomisation (1:1 ratio), stratified by hospital site. Inclusion criteria: Adult (age=18), hospitalised needing mechanical ventilation, likely to remain ventilated 24 hours following randomisation. Health technologies being assessed: An advanced airways protection device versus conventional endotracheal tube (with or without basic subglottic suction and standard cuff). Primary outcome: Duration of mechanical ventilation (from randomisation to liberation from ventilation). Secondary outcomes: all-cause mortality, (28 days, 3 & 6 months) ICU/hospital stay, duration of intubation, re-intubation rates, extubation rates, tracheostomy rates, VAP; (safety): adverse events; utilisation of cost of NHS resources; quality-adjusted life years; incremental cost per quality-adjusted life year gained; incremental cost per VAP avoided. Sample size: 2194 patients (90% power, 5% alpha, to detect 1 day difference in median duration of mechanical ventilation). TIMELINE OF DELIVERY: 63 months: 6-months set-up; 9-months internal pilot; 39-months recruitment; 6-months follow-up; 3-months data analysis, reporting and dissemination. ANTICIPATED IMPACT AND DISSEMINATION: The study will provide definitive evidence for the most effective airway protection device for patients who require mechanical ventilation. The findings will define future NHS and international practice. We will publish lay and professional summaries in written, audible and infographic styles. We will promote at public engagement events and develop informative, patient facing website material and leaflets. We will disseminate to clinicians through peer-reviewed publications, podcasts, blogs, conference presentations and social media. We will engage policy makers through our membership of key organisations.