Muscular Electrostimulation of the Sedated and Mechanically Ventilated Critically Ill Patient. Analysis of the Effect on Acquired Muscular Weakness and Its Clinical Consequences.

Study Overview
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Brief Summary
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Even 20-50% of patients under sedation and mechanical ventilation develops myopathy and / or neuropathy which difficulties both the process of extubation and the functional recovery. The objective of this project is to analyze the effect of muscle electrostimulation (ESM) on muscle weakness acquired in Intensive Care Unit (ICU) and its consequences. Study design: a single center, prospective, randomized trial to be held in the ICU of  Universitarian hospital La Fe in collaboration with the service of Neurophysiology of the hospital. All patients undergoing sedation and mechanical ventilation (with an expected duration longer than 48h) and without any of the exclusion criteria detailed in the Methodology section will be included in the study. The intervention will consist of a muscular electrostimulation with the Super Pro Excel 70,UltratoneTM. The stimulation will be performed in 10 muscle groups (5 per side) following established protocols, at least 5 days a week. We will evaluate muscle strength by Medical Research Council scale, functional capacity by Barthel scale and Neurophaty Disability Scale, all clinical events will be collected and electrophysiologic, echographic and histologic parameters will be measured. The process of extubation will be performed following an established protocol, the duration will be collected as the same manner as ICU.

Official Title
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Muscular Electrostimulation of the Sedated and Mechanically Ventilated Critically Ill Patient. Analysis of the Effect on Acquired Muscular Weakness and Its Clinical Consequences.

Conditions
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Polyneuropathy

Intervention / Treatment
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* Procedure: Muscular electrostimulation and percutaneus muscular biopsy.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients older than 18 years. Sedated and mechanically ventilated critically ill patients, more than 48 hours. Exclusion Criteria: Body mass index > 45 or < 20 kg/m2. Pregnant. Epilepsia. Use muscular blocks.

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: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Muscular electrostimulation.<br>The interventions is muscular electrostimulation. | Procedure: Muscular electrostimulation and percutaneus muscular biopsy.<br>* Muscular electrostimulation everyday and percutaneus muscular biopsy weekly.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| muscular weakness | We measure the muscular weakness, with the medical research council scale. | at the time of weaning, 30 days after extubation and one year after extubation. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time of weaning |  | everyday | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Muscular electrostimulation, mechanically ventilated, critically ill patients, muscular weakness.