Does in-bed cycling delivered within 48 hours of mechanical ventilation, reduce the occurrence of delirium in critically ill patients: A mixed-methods feasibility randomised controlled trial protocol

Background: Delirium is a severe neuropsychiatric clinical state presenting as an acute onset of cognitive deficits. Patients receiving invasive mechanical ventilation (IMV), have the highest incidence (50%–80%) of delirium amongst patients admitted to intensive care units. Preliminary data indicates that early mobilisation is associated with reduced delirium in critically ill patients. However, definitive evidence is lacking. Current practice varies due to many barriers to patients, who require IMV, receiving early mobilisation interventions. In-bed cycling may address some of these barriers. This research aims to evaluate the feasibility and acceptability of early in-bed cycling to reduce delirium in critically ill patients. Methods: This multi-site feasibility randomised controlled trial will evaluate early (⩽48 h following IMV), in-bed cycling as a method of early mobilisation, to reduce delirium. Eighty-four participants will be randomised across three sites in a 1:1 ratio, to receive either early in-bed cycling in addition to usual care or usual care alone. The primary outcome is feasibility (recruitment, retention, intervention fidelity). Secondary outcomes include different methods of measuring delirium, physical function, length of stay, ventilator free days, sedation free days, Richmond Agitation Sedation Scale, adverse events and mortality. Descriptive statistical analyses will be conducted. Hypothesis testing will be used for exploratory analysis of the mechanistic sub-study outcomes. An embedded qualitative interview study will evaluate the acceptability of this research. Conclusion: This trial has been prospectively registered (ISRCTN74277350) and received full ethical approval (REC reference: 24/SC/0096). The trial opened to recruitment in July 2024. Recruitment will take place across 18-months.