Treatment of Muscle Weakness in Critically Ill Patients

The basic study design is to:

1. Obtain informed consent from patient or the patients LAR

2. Randomize subjects to treatment with either:

1. Sham therapy, consisting of bilateral placement of Niveus Medical Muscle
Stimulation System 110 electrodes for 30 minutes twice daily without activation of
the electrical circuitry of the unit, or

2. Active therapy, using the Niveus Medical Muscle Stimulation System 110 electrodes
to actively produce a rhythmic quadriceps contraction for 30 minutes twice daily

3. Measure magnetic stimulated quadriceps twitch (QuadTw) strength bilaterally as well as
ultrasound assessment of quadriceps size

4. Continue sham or active treatment daily for 7 days for a total of 14 sessions

5. Repeat measurements of magnetic stimulated QuadTw strength and ultrasound assessment of
quadriceps size on Day 8 or before Day 8 if the subject is to be discharged from the
hospital prior to the allotted duration of sham or active treatment

6. Functional measurement of the patient using the Functional Status Score for the ICU
(FSS-ICU) at the end of the treatment period or upon discharge

7. A member of the research team will visit the subject until hospital discharge and will
record total duration (days) of mechanical ventilation, duration (days) of mechanical
ventilation following study entry, duration of ICU stay, ventilator weaning time (days
measured from time of first spontaneous breathing trial to extubation), and total
duration (days) of hospitalization

8. We will also review each subject's medical record on entry into the study to obtain
demographic information including the following: age, sex, diagnoses, medications,
reason for institution of mechanical ventilation, vital signs at the time of the initial
visit, bedside parameters of mechanical ventilation use (including mode of ventilation,
duration of ventilation, level of oxygen, breath volume and rate, % triggered breaths),
most recent arterial blood gas values, and chest radiograph readings at the time of the
initial visit. We will also record the subject's weight, BMI and total intake and output
values since admission to the ICU. In addition, we will monitor each subject's progress
in the ICU daily by reviewing the subject's medical record and recording the clinical
parameters as well as recording daily weights and total intake and output. These
parameters will also be assessed until the time that the patient is discharged from the
ICU. In addition, we will record and note all physical therapy and occupational therapy
sessions that the subject receives as part of the standard of care in the ICU and in the
hospital up until the time of discharge. In the University of Kentucky hospital,
occupational therapy records the Barthel Index at each session which uses a scale of
0-100 to assess an individual's functional independence when performing activities of
daily living (ADLs). Physical therapy assesses functional status using Kansas University
Hospital Physical Therapy Acute Care Functional Outcomes, which also assesses functional
status in the categories of bed mobility, transfer, gait and walking distance.

Inclusion Criteria:

- Acute respiratory failure requiring mechanical ventilation

Exclusion Criteria:

- Attending physician on service determines that patient too unstable to tolerate
measurements

- Patient requires > 15mcg/min norepinephrine or > 15mg/kg/min of dopamine.

- Fraction of inspired oxygen > 80% or positive end expiratory pressure > 15 cm H20
requirements.

- Cardiac pacemaker or implanted defibrillator.

- Neuromuscular blocking agents delivered within 48 hours of preceding testing.

- Existing neuromuscular disease.

- Profound uncorrectable hypokalemia (< 2.5) OR hypophosphatemia (< 1.0)

- Acute lower extremity deep vein thrombosis

- Pregnancy

- Prisoner

- Institutionalized patient

- If primary attending determines that patient is terminal and will likely have care
withdrawn within 7 days

- Do not resuscitate order

- Body mass index > 40

- Patients requiring mechanical ventilation more than 4 days prior to study entry