Effect of All-Stim 2 Quadriceps Treatments on Limb Muscle Strength In Mechanically Ventilated Patients

NCT02332187 | Terminated Results DMC FDA Device

• 1 other identifier: Protocol 12-0807-F6A
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Weakness

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Duration of Hospitilization

  Baseline to discharge in weeks, up to five weeks

Study Arms (2)

Sham electrical stimulation

SHAM COMPARATOR

The intervention will consist of sham electrical stimulation using an All Stim stimulator of each quadriceps leg muscle for 30 minutes per day for a total of 7 days.

Device: Sham electrical stimulation using an All Stim stimulator

Active electrical stimulation

ACTIVE COMPARATOR

The intervention will consist of active electrical stimulation using an All Stim stimulator of each quadriceps leg muscle for 30 minutes per day for a total of 7 days.

Device: Active electrical stimulation using an All Stim stimulator

Interventions

Active electrical stimulation using an All Stim stimulator DEVICE

This is an FDA approved stimulator that is used for strengthening the quadriceps muscle.

Active electrical stimulation

Sham electrical stimulation using an All Stim stimulator DEVICE

With this intervention the All Stim unit is turned off and no electrical stimulation is provided.

Sham electrical stimulation

Eligibility Criteria

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

You may qualify if:

• Adult patients requiring mechanical ventilation for more than 48 hours
• Respiratory failure present

You may not qualify if:

• 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

Sponsors & Collaborators

• Gerald Supinski: lead

Study Sites (1)

Chandler Hospital

Lexington, Kentucky, 40536, United States

Location

MeSH Terms

Conditions

Asthenia

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Gerald Supinski, MD, Professor
• Organization: University of Kentucky

gsupi2@email.uky.edu

859-494-3480

Study Officials

• Gerald S Supinski, MD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 30, 2014
• First Posted: January 6, 2015
• Study Start: January 3, 2013
• Primary Completion: May 5, 2017
• Study Completion: May 5, 2017
• Last Updated: March 2, 2022
• Results First Posted: March 2, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: January 2019
• Access Criteria: Any researcher associated with a University or Pharmaceutical company

Locations

US (1)