Ignite Creation Date:
2025-12-24 @ 2:17 PM
Ignite Modification Date:
2026-02-02 @ 8:22 AM
Study NCT ID:
NCT02247895
Status:
TERMINATED
Last Update Posted:
2020-06-22
First Post:
2014-09-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Muscle Weakness in Critically Ill Patients
Sponsor:
Gerald Supinski
Organization:
Study Overview
Official Title:
Effect of Treatment With the Niveus Medical Muscle Stimulation System 110 on Quadriceps Strength In Mechanically Ventilated Patients
Status:
TERMINATED
Status Verified Date:
2020-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
difficulty meeting enrollment goals
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 14-0237-F3R | OTHER | University of Kentucky | View |