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
| Type | Name | Description |
|---|---|---|
| DEVICE | NEUROMUSCULAR ELECTRICAL STIMULATION | Neuromuscular electrical stimulation will be applied Functional Electrical Stimulation (FES) machine. |
| OTHER | Conventional physiotherapy | The 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.