Clinical Trials Directory

Trials / Unknown

UnknownNCT02298114

Mobilization With Neuromuscular Electrical Stimulation in Critical Care Patients

The Effects of Early Mobilization With Neuromuscular Electrical Stimulation in Critical Care Patients

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
24 (estimated)
Sponsor
Hospital de Clinicas de Porto Alegre · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

Neuromuscular electrical stimulation in pectoral muscles (fibres of the pectoralis major muscle bilaterally) and rectus abdominis muscles (bilaterally) preserves / decreases the loss of muscle mass.

Detailed description

Introduction: Neuromuscular electrical stimulation (NMES) has recently began to be used as an early treatment method for Intensive Care Unit (ICU) patients on invasive mechanical ventilation (IMV) to compensate for or reduce muscle mass losses and muscular atrophy. Objective: To evaluate the effects of early mobilization with neuromuscular electrical stimulation in critical care patients on invasive mechanical ventilation. Methods: Randomized clinical trial to be conducted in the ICU at the hospital de clínicas of Porto Alegre, RS, Brazil, with two groups, one intervention group (conventional physiotherapy and NMES) and one placebo group (conventional physiotherapy and placebo NMES). Patients on mechanical ventilation who meet the inclusion criteria will be recruited and the intervention will be administered using a 4-channel Ibramed® Neurodyn Functional Electrical Stimulation (FES) machine, every day for thirty minutes until extubation or death. Outcomes will be muscle thickness of pectoral and abdominal muscles and diaphragm excursion measured with ultrasound, before intervention, on the seventh day of intervention and soon after extubation. Additionally, blood lactate and heart rate variability will be assessed. Statistical analysis will be conducted using the Statistical Package for the Social Sciences (SPSS) 20.0 and the significance level will be p\<0.05.

Conditions

Interventions

TypeNameDescription
DEVICENEUROMUSCULAR ELECTRICAL STIMULATIONNeuromuscular electrical stimulation will be applied Functional Electrical Stimulation (FES) machine.
OTHERConventional physiotherapyThe control group will receive conventional physiotherapy associated the placebo electrical stimulation

Timeline

Start date
2013-08-01
Primary completion
2015-12-01
Completion
2015-12-01
First posted
2014-11-21
Last updated
2015-12-22

Locations

1 site across 1 country: Brazil

Source: ClinicalTrials.gov record NCT02298114. Inclusion in this directory is not an endorsement.