Treatment of Muscle Weakness in Critically Ill Patients

NCT02247895 | Terminated DMC FDA Device

• 2 other identifiers: 06201414-0237-F3R
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Illness; Respiratory Failure; Myopathy; Weakness

Keywords

ICU Acquired weakness; Critical illness; Mechanical ventilation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Total ICU length of stay

  Discharge from ICU, Average 7-10 days

• Hospital Length of Stay

  Hospital discharge, Average 14-21 days

• Functional Status Score for ICU

  ICU discharge, Average 7-10 days after study entry

• Duration of mechanical ventilation after study entry

  Until patient is successfully weaned from mechanical ventilation, Average 4-10 days

• Change in quadriceps twitch force generation

  Baseline (prior to Treatment) and Day 8

Other Outcomes (1)

• Rectus Femorus thickness

  Day 8

Study Arms (2)

Sham Treatment

SHAM COMPARATOR

Sham stimulation twice daily

Device: Sham Treatment

Active Treatment

ACTIVE COMPARATOR

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

Interventions

Sham Treatment DEVICE

Subjects will undergo the same protocol as the treatment group except no electrical stimulation will be applied.

Also known as: Sham treatment without electrical stimulation

Sham Treatment

Electrical stimulation DEVICE

Two thirty minute sessions of neuromuscular electrical stimulation applied to both quadriceps for seven days for a total of 14 treatments

Active Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Acute respiratory failure requiring mechanical ventilation

You may not qualify if:

• 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

Sponsors & Collaborators

• Gerald Supinski: lead

Study Sites (1)

University of Kentucky Medical Center

Lexington, Kentucky, 40586, United States

Location

MeSH Terms

Conditions

Critical Illness; Respiratory Insufficiency; Muscular Diseases; Asthenia

Interventions

Electric Stimulation

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Stimulation; Investigative Techniques

Study Officials

• Gerald S. Supinski, MD

  Professor of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Staff Physician, Division of Pulmonary, Critical Care and Sleep Medicine, Principal Investigator, Professor of Medicine

Study Record Dates

• First Submitted: September 2, 2014
• First Posted: September 25, 2014
• Study Start: December 1, 2016
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2018
• Last Updated: June 22, 2020

Record last verified: 2020-06

Locations

US (1)