RosProx: Preventing muscle wasting in critically ill patients by repetitive occlusive stimulus (ROS): a feasibility study

Study code 
CTU-8
Disease 
Critical Care (ICU)
Recruitment 
Open
Date 
04/09/2017 to 31/12/2018

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:

Trial processes:

  • 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?

Assess outcomes:

  • 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?

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