To observe and identify determinants of recovery from intensive care unit-acquired weakness (ICUAW) following a severe cardiorespiratory failure requiring extra-corporeal membrane oxygenation (ECMO). Additionally, to discover the effects of ICUAW on physical function and health-related quality of life (HRQoL) after critical illness. CLEVERER is a clinical observational pilot study.
Above the age of 18
Adults with severe cardio-respiratory failure requiring ECMO.
Adults who have had personal and professional consultees agree to enrol them in the trial.
Previous Stroke
Neuromuscular disease
Malignancy
Underlying neuromuscular disease
Adults with severe cardiac or respiratory failure requiring extra-corporeal membrane oxygenation with no pre-existing muscle weakness or wasting.
Cohort
Prospective
Not listed
To observe the change in cross sectional area of the Rectus Femoris (RFcsa, measured in cm2) during critical illness and recovery.
RFcsa will be calculated using B-mode ultrasound (US) at pre-determined time points. Additionally, the images acquired will have histogram analysis in adobe photoshop software. The RFcsa will be correlated with indices of muscle strength and HRQoL. A larger RFcsa with reduced pixel density suggests greater muscle quality and function.
To Observe a change in Hand Held Dynamometry strength and correlate this with RFcsa, function and HRQoL during critical illness and recovery.
Hand-held dynamometry will be calculated using the JAMAR hand-held hydraulic dynamometer. We will assess both hands and take the mean of 3 trials, producing a maximal grip result. A higher score indicates better global strength and function.
To observe a change in Knee straightening dynamometry, strength and joint moment (torque) and correlate this with RFcsa, function and HRQoL during critical illness and recovery.
The test will be conducted using a Lafayette Manual Muscle Tester. Joint knee moment (torque) and strength will be measured. A higher result from joint knee moment and strength indicates a greater global strength and function.
To test the Medical Research Council Sum Score (MRC-SS). MRC-SS measures global strength and ambulation
This test will be conducted once to reaffirm whether patients' have ICUAW. A score can range from 0 (paralysis) to 60 (normal strength). A score of less than 48 indicates the patient has ICUAW. Therefore, a lower score is associated with worse outcomes.
The secondary aim is to understand the molecular profile (bloods).
Blood analysis will contain and analyse but not limited to markers of oxidative stress injury, inflammation, MiRNA and injury to multiple organs will be quantified. We will collect, store and analyse buffy coat and plasma to understand these profiles.
Urine Analysis
Urine analysis measures albumin-creatinine ratio (ACR).
Muscle Biopsy
A muscle biopsy will be taken from patients whilst under anaesthesia. The biopsy observes pathways relevant to muscle homeostasis using biochemical and molecular techniques.
Vascular endothelial cell sampling
Cell samples will be acquired from insertion of the central line.
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Barts & The London NHS Trust
Lead sponsor
Queen Mary University of London
Collaborator
