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)

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.

A breathing tube is the pathway through which air flows into the lungs. Intensive care units (ICU) are specialist hospital wards that provide treatment and monitoring for people who are very ill. Close to 184,000 patients annually are admitted to NHS ICUs and 33% require help with a breathing machine. Treatment involves placing a plastic tube through the mouth into the windpipe and attaching the person to a breathing machine. A serious complication of this life-saving treatment is a chest infection or Ventilator Associated Pneumonia (VAP) and affects 20% of people on breathing machines. It occurs when infected mucus drip down the back of the throat past the plastic tube into the lungs.

Whilst VAP can be treated with antibiotics, some people will die, and others will spend much longer on a breathing machine. Advanced airway protection aims to improve the windpipe seal and reduce the risk of infective mucous passing down to the lung, by maintaining the inflation of the protective cuff.

Patient studies suggest that these systems are safe, effective at removing mucous and preventing lung infection. Some hospitals are using advanced airway protection systems. However, we do not know if the positive findings seen in a few hospitals would be seen in the wider NHS, and whether the new tube is cost effective, resulting in benefit to patients. NICE have therefore recommended a large-scale research study to see if this equipment is needed.

We aim to recruit 2194 patients

The primary outcome is the duration of mechanical ventilation as measured from time of randomisation to first successful unassisted breathing, measured in days.