Facilitating Functional Independence in Patients Receiving Prolonged Mechanical Ventilation
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- RML Specialty Hospital
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Time to reach independence in performing functional activity
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Neuro-muscular electrical stimulation
Intervention:Neuromuscular electrical stimulation (NMES)
NMES stimulation will be applied to lower extremity muscle groups up to 5 days a week until discharge. Standard physical therapy will also be administered by a therapist distinct from the therapist administering NMES
Intervention: Neuromuscular electrical Stimulation (NMES) (Device)
Sham stimulation
Intervention: sham stimulation
Sham stimulation will be applied to lower extremity muscle groups up to 5 days a week until discharge. Standard physical therapy will also be administered by a therapist distinct from the therapist administering sham-NMES
Intervention: Sham Stimulation (Device)
Outcomes
Primary Outcomes
Time to reach independence in performing functional activity
Time Frame: Hospital discharge, an expected average stay of 5 weeks
Functional activity as measured by functional activity measurement for the ICU (FSS-ICU)
Secondary Outcomes
- The percentage of patients who can perform functional activities independently(Hospital discharge, an expected average stay of 5 weeks)
Investigators
Amal Jubran
Principal Investigator-Staff Physician
RML Specialty Hospital