A randomised crossover trial of staff time with proned patients in the ICU using the 'BathMat'

BACKGROUND: The technique of turning a ventilated patient into the prone position is one which has a strong evidence base for improving both oxygenation and patient survival in the intensive care unit (ICU). As such, proning is advocated in national and international guidance. To mitigate the risk of complications, national guidance recommends repositioning proned patients every 2-4 h. The current process of repositioning is associated with risk and requires multiple staff members recurrently during the period of prone therapy. There is therefore an urgent need to explore safer and more efficient techniques. To address these issues, a multi-vessel inflatable pillow (the 'BathMat') has been developed which aims to improve the safety and ease of repositioning, whilst reducing the number of staff and the time required. Inflation of the BathMat, which is placed beneath a proned patient, allows easy repositioning of the head and arms, before deflation returning the patient to the resting position. The device requires clinical testing to assess its benefits outside of simulated scenarios.

METHODS: The BathMat trial is a randomised, multicentre, single-blind crossover study of repositioning in ventilated proned patients in ICU using the BathMat vs conventional care. Ventilated patients who require proning will be randomised to be repositioned with standard care or the BathMat. The same repositioning method will be used throughout each proning session, but will alternate on subsequent proning sessions between BathMat and standard care. The primary outcome is the difference in total staff time (number of staff × total time taken) required to reposition a patient with the BathMat compared with standard care. Secondary outcomes are the number of repositioning exercises performed, the number of adverse incidents associated with repositioning, the ease of manual handling, and the health economic costs of the complications of proning.

DISCUSSION: This is the first clinical trial of a device specifically designed to improve the quality of patient care delivered and improve the staffing resources required to care for proned ICU patients. The impact potential for patients and staff is significant, through liberation of staff, improved manual handling, and risk mitigation for proned patients. Trial registration ClinicalTrials.gov NCT06844617. Registered on Jan. 19, 2025. https://clinicaltrials.gov/study/NCT06844617.