Trial Outcomes & Findings for Use of Neuromuscular Electrostimulation (NMES) for Treatment or Prevention of ICU-Associated Weakness (NCT NCT00709124)

3 medical and surgical ICUs at Johns Hopkins Hospitals screened for recruitment from 2008-2009 and 2010-2013 (39 months in total). Recruitment suspended for 17 consecutive months between 2009-2010 due to lack of staffing

2 patients (both randomized to the intervention group) were withdrawn PRIOR to any initiation of intervention due to new data arising after randomization (and before intervention initiation) that indicated the subject met the pre-existing exclusion criteria.

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

Range 0 to 30 with higher score better. The composite score is a simple sum of the individual scores from the 3 bilateral muscle groups

Strength (in pounds) - measured via handheld dynamometry of tibialis anterior, gastrocnemius, and quadriceps

Measuring strength of 6 muscle groups in arms and legs using Medical Research Council composite score (each muscle group scored from scale of 0 \[no visible or noticeable contraction\] to 5 \[maximum strength\] and the sum of the scores for the 6 muscle groups equate to a composite score ranging from 0 to 60, higher score is better).

Hand grip strength measured using a dynamometer (measured in kilograms, then compared to age- and sex-matched population norms to yield % predicted)

Measured using maximal inspiratory pressure (MIP) measurements that is then compared to predicted values for each participant (i.e., % predicted)

Evaluates a patient's physical function in the ICU setting. Each task is scored, ranging from 0 (unable to perform) to 7 (complete independence).The total score ranges from 0-35, with higher scores indicating better physical functioning.

The number of days the patient was on mechanical ventilation.

The number of days that the patient was in the ICU and hospital, respectively.

The number of patients who died in the ICU and those who died by hospital discharge.

The total dollar amount of charges from hospital stay

Discharge location after hospital stay.

Measured via manual muscle strength test using a composite Medical Research Council (MRC) score with each muscle group rated with score ranging from 0 (no visible or noticeable contraction of the muscle) to 5 (maximum strength). The sum of the scores for the lower limb muscle groups can range from 0 to 30 (higher score is better)

The mean change of the sum of the lower limb strength scores between awakening and ICU discharge and between ICU discharge and hospital discharge. Three lower limb muscle groups are assessed bilaterally (each muscle group scored from scale of 0 \[no visible or noticeable contraction\] to 5 \[maximum strength\]). The scores are then summed for each patient at each time point (range 0 -30, higher score is better).

Proportion of ICU days the patient had delirium

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 whole body muscle strength score from baseline to ICU discharge, mean change in whole body muscle strength score from baseline to hospital discharge, and whole body muscle strength score at ICU discharge and at hospital discharge. Each muscle group is assessed bilaterally (scale of 0 \[no visible or noticeable contraction\] to 5 \[maximum strength\]). There are three muscle groups assessed bilaterally for lower extremity (hip flexion, knee extension, and ankle dorsiflexion) (score range 0-30, higher score is better i.e. stronger); while for whole body strength assessment (score range 0-360, higher score is better), the following additional muscles are assessed: shoulder abduction, elbow flexion and wrist extension. The scores are then summed for each patient at each time point.