MyokinE100 System: Closed Loop Electrical Muscle Stimulation to Mitigate ICU Acquired Weakness in Medical ICU Patients

Safety and Feasibility of the MyokinE100 System in ICU Settings to Mitigate ICU Acquired Weakness

The goal of this clinical trial is to learn if a new medical device that sends electrical signals to the thigh muscles is safe and easy to use for people in the ICU (Intensive Care Unit) who are at risk of losing muscle strength. It will also explore whether this treatment can help slow down muscle weakening.

The main questions this study aims to answer are:

• Do participants develop medical problems when receiving electrical muscle stimulation in the ICU?
• Is electrical muscle stimulation a practical way to help reduce muscle weakness in critically ill patients?

Researchers will compare the control group (standard of care) to the intervention group (standard of care plus 60-minute sessions of electrical muscle stimulation daily during the ICU stay) to see if the device is safe and easy to use.

Participants will:

• Receive either standard of care or standard of care plus electrical muscle stimulation of the thigh muscles
• Have their muscle strength checked during the study
• Complete a survey three months after ICU discharge to check on their recovery

Inclusion Criteria:

• Admitted to ER or ICU within the previous 48 hours
• APACHE II score ≥ 13
• Meets the criteria for sepsis or severe sepsis

Exclusion Criteria:

• Anticipated transfer to an ICU not participating in this study
• Myopathies (e.g. congenital)
• Acquired myopathies with CK levels 5-times above the upper limit of normal
• Unable to transfer from bed to chair at baseline
• Moribund
• Comfort care
• New onset deep vein thrombosis within the previous 6-months
• Malignancy in lower limb
• Technical obstacles - fracture, burns, amputation
• Open wound or skin abrasion at the garment application site
• Pregnancy
• Pacemaker and implantable cardioverter-defibrillator