Use of Neuromuscular Electrostimulation (NMES) for Treatment or Prevention of ICU-Associated Weakness

• Lower extremity strength, at hospital discharge, of 3 bilateral muscle groups (pretibial, triceps surae, and quadriceps) measured via MMT using a composite Medical Research Council (MRC) score [ Time Frame: At hospital discharge ] [ Designated as safety issue: No ]
  

• Individual muscle strength: Pretibial, triceps surae, and quadriceps (MRC score) between those who receive NMES vs. sham sessions [ Time Frame: ICU and hospital discharge ] [ Designated as safety issue: No ]
  
• Overall body strength: 6 bilateral muscle groups in arms and legs (MRC composite score) between those who receive NMES vs. sham sessions [ Time Frame: ICU and hospital discharge ] [ Designated as safety issue: No ]
  
• Overall body strength: Hand grip between those who receive NMES vs. sham sessions [ Time Frame: ICU and hospital discharge ] [ Designated as safety issue: No ]
  
• Respiratory muscle strength: Maximum Inspiratory Pressure (MIP) between those who receive NMES vs. sham sessions [ Time Frame: ICU and hospital discharge ] [ Designated as safety issue: No ]
  
• Functional status as measured by modified Functional Independence Measurement (FIM) score between those receiving NMES vs. sham sessions [ Time Frame: ICU and hospital discharge ] [ Designated as safety issue: No ]
  
• Duration of mechanical ventilation [ Time Frame: At hospital discharge ] [ Designated as safety issue: No ]
  
• ICU and hospital length of stay [ Time Frame: Hospital discharge ] [ Designated as safety issue: No ]
  
• ICU and in-hospital mortality [ Time Frame: Hospital discharge ] [ Designated as safety issue: No ]
  
• Total hospital charges [ Time Frame: Hospital discharge ] [ Designated as safety issue: No ]
  
• Hospital discharge destination (e.g., home, rehab facility) [ Time Frame: Hospital discharge ] [ Designated as safety issue: No ]
  
• Lower extremity strength, at hospital discharge, of 3 bilateral muscle groups (pretibial, triceps surae, and quadriceps) measured via MMT using a composite Medical Research Council (MRC) score [ Time Frame: At ICU discharge ] [ Designated as safety issue: No ]
  
• Mean change in subject's lower extremity MRC composite score from baseline [ Time Frame: At ICU and Hospital discharge ] [ Designated as safety issue: No ]
  
• ICU Delirium [ Time Frame: Number of days with delirium in the ICU ] [ Designated as safety issue: No ]
  
• Subgroup analysis [ Time Frame: See description ] [ Designated as safety issue: No ]
  For patients with >= 7 days of mechanical ventilation, we will compare the 2 groups for the following outcomes: Lower extremity muscle strength, mean change in MRC score from baseline to ICU discharge, mean change in MRC score from baseline to hospital discharge, and composite whole body MRC score at ICU dischare and at hospital discharge.
  
  

Survivors of critical illness frequently have significant, debilitating and persistent weakness after discharge from the intensive care unit (ICU). This weakness can persist for up to 4 years after ICU discharge. There are few interventions that have been successful in reducing or preventing weakness. Neuromuscular electrostimulation (NMES) therapy is beneficial in other populations of weak and functionally limited patients, such as those with chronic respiratory failure requiring mechanical ventilation, severe chronic obstructive pulmonary disease and end-stage congestive heart failure. We propose a randomized clinical trial to evaluate the efficacy of 60 minutes of NMES versus sham therapy, applied to the bilateral lower extremities, to reduce ICU-associated weakness in patients with acute respiratory failure. Our specific aims are to determine if NMES therapy will: 1) increase strength of the 3 treated lower extremity muscle groups (i.e., pretibial, triceps surae, and quadriceps), 2) improve important clinical outcomes (i.e., functional status, duration of mechanical ventilation, length of ICU and hospital stay, in-hospital mortality, and total hospital charges), 3) reduce critical illness myopathy as an etiology of weakness in clinically weak ICU patients. We hypothesize that NMES therapy will reduce ICU-associated weakness, and improve clinical and functional outcomes. Additionally, the rates of critical illness myopathy as an etiology of weakness in clinically weak ICU patients will be lower in those receiving NMES versus sham therapy. Since there is no single test that is optimal for measuring muscle strength in the critically ill, we will employ four non-invasive measures: manual muscle testing (MMT), hand held dynamometry (HHD), handgrip dynamometry (HGD), and maximal inspiratory pressure (MIP). With no existing therapeutic options available, our study explores the potential of NMES as a feasible intervention to reduce ICU-associated weakness.