Electro-Neuro-Muscular Stimulation in ICU

Study Overview
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Brief Summary
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We will examine whether the application of electro-neuro-muscular stimulation (ENMS) in critical care patients, can decrease the impact or severity of the critical illness myopathy (CIM) or neuropathy. We will also assess whether electro-neuro-muscular stimulation affect the incidence density rate of nosocomial pneumonia in the ICU. Patients will be divided into two groups, Group A and Group B chosen at random. In Group A conventional physiotherapy will be applied while in Group B, ENMS will also be applied additional to physiotherapy, in the quadriceps muscles. The total time of applying ENMS will be 1 hour, it will be applied before the start of the physiotherapy per day of hospitalization and for 10 days in each patient. The definition of CIM will be based on pathology muscular biopsy (quadriceps). Patients will undergo biopsy on the 1st and 11th day after entering the study. The technique of Gomori Trichrome will be used to determine the existence or absence of myopathy. In addition the ATPase technique will be applied at different prices of PH (PH: 9,4, PH: 4,6 and PH : 4.3), thus achieving a separation of myopathy and neuropathy. The primary outcome of the study will be the incidence of myopathy in both groups, at day 12th. Considering that the incidence of myopathy in critically ill patients is 80% reducing this rate by 50% in the intervention group using statistical power equal to 0.80 up to a level of p <0.05, 12 number of patients will be required in each group.

Official Title
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Electro-Neuro-Muscular Stimulation in Hospitalized Intensive Care Patients

Conditions
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Myopathy, Neuropathy

Intervention / Treatment
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* Other: Patients will receive daily sessions of electro-neuro-stimulation in the quadriceps muscle for 10 days


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged>18 years old and <85 years old, hospitalized in the ICU for at least 96 hours Exclusion Criteria: pregnancy, autoimmune disease, pre-existing known neuromuscular diseases, presence of bone fractures on the lower extremities, use of corticoids

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Electro-Neuro-Muscular Stimulation<br>Patients will receive daily sessions of electrostimulation with a commercially available device (En-Stimulation 4, Netherlands) in the quadriceps muscle for 10 days | Other: Patients will receive daily sessions of electro-neuro-stimulation in the quadriceps muscle for 10 days<br> <br> |
| No Intervention: Control<br>Patients in this arm will receive the usual standard treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of myopathy | Presence of myopathy in critical care patients; myopathy will be assessed with biopsy of quadriceps at day 12 after entering the study (17 day of ICU hospitalization) | 12 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NEUROPATHY | presence of peripheral neuropathy after 12 days of hospitalization in the ICU | 12 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ICU,, MYOPATHY,, NEUROPATHY,, PNEUMONIA