Mobilization With Neuromuscular Electrical Stimulation in Critical Care Patients

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Muscular Atrophy

Intervention / Treatment
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* Device: NEUROMUSCULAR ELECTRICAL STIMULATION
* Other: Conventional physiotherapy


Participation Criteria
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Eligibility Criteria
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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: Exclusion criteria will include neuromuscular diseases causing motor deficits, such as strokes, multiple sclerosis, amyotrophic lateral sclerosis, myasthenia gravis and Guillain Barré syndrome. Patients will also be excluded in the event of extubation less than 48 hours after enrolment on the study; complications during the protocol, such as pneumothorax, reintubation or delayed weaning (3 failed spontaneous ventilation tests); body mass index (BMI) > 35 kg/m2; pacemaker use, history of epilepsy; or if a patient has undergone an operation involving abdominal or pectoral incisions.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: neuromuscular electrical stimulation<br>Neuromuscular electrical stimulation will be applied Functional Electrical Stimulation (FES) machine. The electrodes will be placed over the motor points of the following muscles: pectoral muscles (fibres of the pectoralis major muscle) and rectus abdominis muscles (bilaterally) The first training session will have a duration of 30 minutes , which will then be extended by 1 minute for every 2 days of administration. The intensity will be increased until muscle contraction is visible or palpable or, intensity will be adjusted according to tolerance associated conventional physiotherapy. Neuromuscular electrical stimulation will be applied held until extubation end conventional respiratory and motor physiotherapy until discharge from the ICU. | Device: NEUROMUSCULAR ELECTRICAL STIMULATION<br>* Neuromuscular electrical stimulation will be applied Functional Electrical Stimulation (FES) machine.<br>|
| Sham Comparator: Conventional physiotherapy<br>Conventional physiotherapy will be administered by professionals from the physiotherapy department twice a day, for 30 minutes. The protocol will include upper and lower extremity functional diagonals from the proprioceptive neuromuscular facilitation method (two series of 10 repetitions for each bilateral diagonal), manual bronchial hygiene exercises, such as thoracic vibrocompression, manoeuvres with a manual resuscitator (bag squeezing) and aspiration of secretions where necessary. Associated will receive placebo electrical stimulation, in this case the procedure is the same, but intensity is set to a sensory level, not high enough to provoke either visible or palpable muscle contractions. | Other: Conventional physiotherapy<br>* The control group will receive conventional physiotherapy associated the placebo electrical stimulation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in muscle thickness of pectoral and rectus abdominis muscles | 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 | baseline and after seven days of protocol or 24 hours after extubation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change Thickness of Diaphragm | 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 | baseline and after seven days of protocol or 24 hours after extubation . | 
| blood lactate levels | 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. | first day of protocol | 
| Change Excursion of the Diaphragm | 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 | baseline and after seven days of protocol or 24 hours after extubation . | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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electrical stimulation, intensive care unit, muscular atrophy