Weakness Clinical Trial
Official title:
Effect of All-Stim 2 Quadriceps Treatments on Limb Muscle Strength In Mechanically Ventilated Patients.
Verified date | February 2022 |
Source | University of Kentucky |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Patients that are on mechanical ventilators in medical intensive care units (MICU) have extremely weak leg muscles. Currently there is no treatment to prevent or reverse this weakness. Treatments with a thigh muscle stimulator, called an All Stim 2, can improve leg muscle strength and help patients regain leg function after knee surgery. The purpose of the present study is to determine if treatments with the All Stim 2 device can also improve leg muscle strength in patients on mechanical ventilation.
Status | Terminated |
Enrollment | 15 |
Est. completion date | May 5, 2017 |
Est. primary completion date | May 5, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Adult patients requiring mechanical ventilation for more than 48 hours - Respiratory failure present Exclusion Criteria: - The physician caring for the patient determines that the patient is too unstable - Use of high dose pressors (more than 15 mcg/min of norepinephrine or more than 15 mg/kg/min of dopamine) - Use of more than 80% FiO2 (fractional concentration of oxygen) or more than 15 cm H2O (water) of PEEP (positive end expiratory pressure) - Presence of a cardiac pacemaker or implanted defibrillator - Use of neuromuscular blocking agents within the 48 hours preceding testing - History of a preexisting neuromuscular disease - Presence of profound and uncorrectable hypokalemia (less than 2.5) or hypophosphatemia (less than 1.0) - Pregnancy - If the patient is a prisoner - If the patient is institutionalized - If it is thought that the patient will have care withdrawn within 7 days |
Country | Name | City | State |
---|---|---|---|
United States | Chandler Hospital | Lexington | Kentucky |
Lead Sponsor | Collaborator |
---|---|
Gerald Supinski |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Quadriceps Muscle Strength | The investigators will measure quadriceps leg strength before and after one week of either sham or active electrical stimulation of the quadriceps muscle. | Baseline and One week | |
Secondary | Duration of Hospitilization | The investigators will record the total time patients remain hospitilized after entry into the study. | Baseline to discharge in weeks, up to five weeks |
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