Overview
PROTECT AIRWAYS
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 (PROTECT Airways)
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The PROTECT Airways trial is looking to see if advanced airway protection systems, that connect critically ill patients to breathing machines, shorten duration of ICU care and are cost effective. The advanced airway protection system being tested is already approved for use in the NHS and available in some hospitals, so no serious risk to participants is anticipated.
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​​​The primary outcome is the duration of mechanical ventilation as measured from time of randomisation to first successful unassisted breathing, measured in days.
Intervention
Intervention An advanced airways protection device consists of a flexible ETT with ports for subglottic suction/irrigation as well as a port to attach to an electronic system to maintain cuff pressure. The Venner PneuX™ device was recommended for testing in a large scale clinical trial by NICE in MTG48.
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The Venner PneuX™ device is a flexible armoured ETT. It has a low-volume, low pressure cuff, that inflates uniformly without folds or creases. The key innovative design is the cuff which does not form microchannels and this prevents micro-aspiration during long term ventilation.
The endotracheal cuff and pilot balloon is connected to an electronic system that continuously maintains, monitors, and regulates the pre-set cuff pressure. It has three sub-glottic suction ports around the circumference to ensure that at least one port is patent for suctioning. Sub-glottic suction ports can facilitate irrigation and aspiration of secretions from the subglottic space.​​​
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INCLUSION CRITERIA
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Adult (age ≥18 years)
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Need for invasive mechanical ventilation
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Likely to remain ventilated for at least 24 hours post randomisation
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EXCLUSION CRITERIA
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​Intubated for more than 24 hours prior to randomisation
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Treatment withdrawal anticipated within next 24 hours post randomisation
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Presence of tracheostomy at screening
