Critical Illness Clinical Trial
Official title:
Effect of Treatment With the Niveus Medical Muscle Stimulation System 110 on Quadriceps Strength In Mechanically Ventilated Patients
Patients who are admitted to the intensive care unit and require mechanical ventilation frequently develop profound respiratory and limb muscle weakness. Studies show that the development of weakness during the ICU stay results in poor outcomes. Currently there are no treatments for this muscle weakness, but it has been suggested that this weakness might improve with physical therapy. Electrical stimulation is a method to provide direct stimulation to the muscles potentially enhancing function and improving strength. The purpose of this study is to test the hypothesis that neuromuscular electrical stimulation of the quadriceps muscle will improve muscle strength in patients who are critically ill on mechanical ventilation.
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. The investigators 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. The investigators will also record the subject's
weight, BMI and total intake and output values since admission to the ICU. In addition,
investigators 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, the investigators
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.
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