Treatment of Muscle Weakness in Critically Ill Patients

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.

Study Overview

• Status: Terminated
• Conditions: Critical Illness; Respiratory Failure; Myopathy; Weakness
• Intervention / Treatment: Device: Sham Treatment; Device: Electrical stimulation

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. 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.

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40586
      • University of Kentucky Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical Feasibility, that is ability to complete therapy sessions	Percentage of patients who completed treatment with the device	Discharge from ICU, Average 7-10 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total ICU length of stay	Average 7-10 days	Discharge from ICU, Average 7-10 days
Hospital Length of Stay	Average 14-21 days	Hospital discharge, Average 14-21 days
Functional Status Score for ICU	Average 7-10 days after study entry	ICU discharge, Average 7-10 days after study entry
Duration of mechanical ventilation after study entry	Average 4-10 days	Until patient is successfully weaned from mechanical ventilation, Average 4-10 days
Change in quadriceps twitch force generation	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)	Baseline (prior to Treatment) and Day 8

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rectus Femorus thickness	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	Day 8

Collaborators and Investigators

• Sponsor: Gerald Supinski
• Investigators: Principal Investigator: Gerald S. Supinski, MD, Professor of Medicine

Study record dates

Study Major Dates

• Study Start: December 1, 2016
• Primary Completion (Actual): February 1, 2018
• Study Completion (Actual): February 1, 2018

Study Registration Dates

• First Submitted: September 2, 2014
• First Submitted That Met QC Criteria: September 23, 2014
• First Posted (Estimate): September 25, 2014

Study Record Updates

• Last Update Posted (Actual): June 22, 2020
• Last Update Submitted That Met QC Criteria: June 18, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Critical illness; Mechanical ventilation; ICU Acquired weakness
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Disease Attributes; Respiratory Insufficiency; Critical Illness; Asthenia
• Other Study ID Numbers: 062014; 14-0237-F3R (Other Identifier: University of Kentucky)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No