Facilitating Functional Independence in Patients Receiving Prolonged Mechanical Ventilation

Muscle Weakness Clinical Trial

Official title:

Facilitating Functional Independence in Patients Receiving Prolonged Mechanical Ventilation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02847988
• Other study ID #: AXJ014
• Secondary ID: R01NR016055
• Status: Recruiting
• Phase: N/A
• Start date: July 2016
• Est. completion date: April 2022

Study information

• Verified date: March 2021
• Source: RML Specialty Hospital
• Contact: Lisa A Duffner, B.A.,B.S.
• Phone: 630-286-4149
• Email: lmikolajewski[@]rmlspecialtyhospital.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary aim of this proposal is to test the effectiveness of neuromuscular electrical stimulation (NMES) in improving functional status and muscle function in patients receiving prolonged mechanical ventilation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: April 2022
• Est. primary completion date: November 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Duration of mechanical ventilation >14 days
• Sufficiently awake
• Able to speak and comprehend English
• Willingness to participate

Exclusion Criteria:

• Cardiopulmonary Instability
• Acute-onset neuromuscular disease
• Lower-extremity amputee or paresis
• Open wound at electrode application points
• Pitting edema grade =3
• Presence of pacemaker, implanted defibrillator, or ventricular-assist device
• inability to transfer from sitting to standing before critical illness

Related Conditions & MeSH terms

• Muscle Weakness

Intervention

Device:
• Neuromuscular electrical Stimulation (NMES)
Electrical stimulation of lower extremities will be applied using an electrotherapy stimulator device (Vectra® Neo). The intensity of stimulation will be titrated based on maximal tolerable muscle contraction
• Sham Stimulation
Sham stimulation of lower extremities will be applied using an electrotherapy stimulator device (Vectra® Neo).

Locations

Country	Name	City	State
United States	RML Specialty Hospital	Hinsdale	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
RML Specialty Hospital	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to reach independence in performing functional activity	Functional activity as measured by functional activity measurement for the ICU (FSS-ICU)	Hospital discharge, an expected average stay of 5 weeks
Secondary	The percentage of patients who can perform functional activities independently	Percentage of patients with an FSS-ICU score = 25 at discharge from LTACH	Hospital discharge, an expected average stay of 5 weeks