Muscular Atrophy
Conditions
Keywords
electrical stimulation, intensive care unit, muscular atrophy
Brief 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.
Interventions
DEVICENEUROMUSCULAR ELECTRICAL STIMULATION
Neuromuscular electrical stimulation will be applied Functional Electrical Stimulation (FES) machine.
OTHERConventional physiotherapy
The control group will receive conventional physiotherapy associated the placebo electrical stimulation
Sponsors
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Hospital de Clinicas de Porto Alegre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
This will be a randomized clinical trial recruiting patients of both sexes aged ≥ 18 years, no more than 15 days after admission to the intensive care unit at the hospital de clínicas de Porto Alegre, after transfer from the emergency department or wards and put on invasive mechanical ventilation for at least 24 hours \-
Exclusion criteria
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in muscle thickness of pectoral and rectus abdominis muscles | baseline and after seven days of protocol or 24 hours after extubation | The initial examination by ultrasound will be performed on the first day of the individual in the protocol and the final examination on the seventh day of the protocol |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change Thickness of Diaphragm | baseline and after seven days of protocol or 24 hours after extubation . | The initial examination by ultrasound will be performed on the first day of the individual in the protocol and the final examination on the seventh day of the protocol |
| blood lactate levels | first day of protocol | realized only on the first day of the protocol, three measures were evaluated: before starting the session of electrostimulation, in half the time of the session and after logout. |
| Change Excursion of the Diaphragm | baseline and after seven days of protocol or 24 hours after extubation . | The initial examination by ultrasound will be performed on the first day of the individual in the protocol and the final examination on the seventh day of the protocol |
Other
| Measure | Time frame |
|---|---|
| extubation success | baseline and after seven days of protocol or 48 hours after extubation |
| length of stay in the intensive care unit | patients will be followed for the duration of intensive care unit stay, an expected average of two weeks |
| length of time on mechanical ventilation | baseline and after seven days of protocol or 24 hours after extubation or deth. |
Countries
Brazil
Contacts
Primary ContactAna Maria Dall' Acqua
Backup ContactAmanda Sachetti
Outcome results
None listed