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Treatment of Muscle Weakness in Critically Ill Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02247895
Recruitment Status : Terminated (difficulty meeting enrollment goals)
First Posted : September 25, 2014
Last Update Posted : May 29, 2019
Information provided by (Responsible Party):
Gerald Supinski, University of Kentucky

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Critical Illness Respiratory Failure Myopathy Weakness Device: Sham Treatment Device: Electrical stimulation Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Device Feasibility
Official Title: Effect of Treatment With the Niveus Medical Muscle Stimulation System 110 on Quadriceps Strength In Mechanically Ventilated Patients
Study Start Date : December 2016
Actual Primary Completion Date : February 2018
Actual Study Completion Date : February 2018

Arm Intervention/treatment
Sham Comparator: Sham Treatment
Sham stimulation twice daily
Device: Sham Treatment
Subjects will undergo the same protocol as the treatment group except no electrical stimulation will be applied.
Other Name: Sham treatment without electrical stimulation

Active Comparator: Active Treatment
The active treatment group will receive neuromuscular electrical stimulation to both quadriceps muscle for 30 minutes twice daily for a total of 14 treatments.
Device: Electrical stimulation
Two thirty minute sessions of neuromuscular electrical stimulation applied to both quadriceps for seven days for a total of 14 treatments

Primary Outcome Measures :
  1. Technical Feasibility [ Time Frame: Discharge from ICU, Average 7-10 days ]
    Percentage of patients who completed treatment with the device (technical feasibility)

Secondary Outcome Measures :
  1. Total ICU length of stay [ Time Frame: Discharge from ICU, Average 7-10 days ]
    Average 7-10 days

  2. Hospital Length of Stay [ Time Frame: Hospital discharge, Average 14-21 days ]
    Average 14-21 days

  3. Functional Status Score for ICU [ Time Frame: ICU discharge, Average 7-10 days after study entry ]
    Average 7-10 days after study entry

  4. Duration of mechanical ventilation after study entry [ Time Frame: Until patient is successfully weaned from mechanical ventilation, Average 4-10 days ]
    Average 4-10 days

  5. Change in quadriceps twitch force generation [ Time Frame: Baseline (prior to Treatment) and Day 8 ]
    Quadriceps twitch force generation will be measured using magnetic stimulation of each femoral nerve and compared to measurements obtained at the time of study entry (baseline-prior to randomization)

Other Outcome Measures:
  1. Rectus Femorus thickness [ Time Frame: Day 8 ]
    Rectus femorus thickness will be measured using ultrasound at baseline (study entry) and on Day 8 of study after either sham treatment or neuromuscular stimulation

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02247895

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United States, Kentucky
University of Kentucky Medical Center
Lexington, Kentucky, United States, 40586
Sponsors and Collaborators
Gerald Supinski
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Principal Investigator: Gerald S. Supinski, MD Professor of Medicine

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Responsible Party: Gerald Supinski, Professor of Medicine, Division of Pulmonary, Critical Care and Sleep Medicine, University of Kentucky Identifier: NCT02247895     History of Changes
Other Study ID Numbers: 062014
14-0237-F3R ( Other Identifier: University of Kentucky )
First Posted: September 25, 2014    Key Record Dates
Last Update Posted: May 29, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Gerald Supinski, University of Kentucky:
ICU Acquired weakness
Critical illness
Mechanical ventilation
Additional relevant MeSH terms:
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Respiratory Insufficiency
Critical Illness
Respiration Disorders
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes