This is a multi-centre randomised feasibility study to assess the feasibility and safety in the administration of ROS as a means to reduce the loss of muscle mass and strength that is observed in ICU patients. It is being carried out at the Royal Surrey County Hospital, Ashford & St Peters Hospitals NHS Foundation Trust, and other sites are due to open.
The primary objective is:
Is it safe and tolerable to apply ROS to a proximal lower limb of ICU patients allocated to the intervention group?
The secondary objectives are:
- Can we screen ICU patients?
- Can we obtain consent and recruit?
- Can we randomise?
- Can we deliver the intervention as intended?
- Can we retain patients in the study?
- Can we perform assessments as intended?
- Can we collect outcome data into the eCRF as intended?
- What are the characteristics of outcome data? Determine the suitable primary outcome measure for definitive trial for sample size calculation.
- Is the trial experience acceptable for patients, personal consultees (next of kin), and staff?