Electrical Muscle Stimulation (EMS), a Preventive and Therapeutic Tool for Critical Illness Polyneuromyopathy (CIPNM)

Study Overview
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Brief Summary
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The purpose of this study is to investigate the role of EMS as a preventive and therapeutic tool of CIPNM. The investigators hypothesized that EMS will prevent the development of CIPNM or have a beneficial role as a therapeutic means in case of CIPNM appearance.

Detailed Description
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CIPNM is one of the most frequent clinical problems encountered in a general ICU. Inflicted patients are characterized by generalized muscle weakness, areflexia, delayed weaning from mechanical ventilation and subsequent increased duration of ICU stay. So far, no therapeutic or preventive tool has been proposed for CIPNM. Electrical muscle stimulation (EMS) has been proposed as an alternative exercise modality in patients with severe chronic obstructive pulmonary disease and chronic heart failure, who cannot perform active exercise. The role of EMS in ICU patients has not been evaluated so far. We designed a randomized intervention study to assess the efficacy of EMS, as a preventive or therapeutic tool in CIPNM. The study consists of two cohorts. In the preventive cohort, patients with Apache II admission score ≥ 13, after stratified (age, gender) randomization, are assigned on the second day after admission to the EMS group or to the control group. In the observation cohort, patients with Apache II < 13 are followed clinically until interruption of sedation. Patients who regain consciousness and are cooperative are assessed clinically for CIPNM. If they are diagnosed with CIPNM, they undergo stratified randomization (age, gender, diabetes mellitus, malignancy) to EMS group or to the control group. EMS will be applied to both lower extremities of the EMS-group simultaneously (quadriceps femoris muscle and peroneus longus) on a daily basis. EMS sessions will continue until patient discharge or death. EMS sessions are supplementary to standard physiotherapy practice applied to all ICU patients. Primary end point is the diagnosis of CIPNM. Secondary end points are 1) the duration of weaning from the ventilator, 2) time to ICU discharge, 3) muscle mass preservation, 4) muscle strength, 5) muscle properties and structure. The primary and secondary endpoints will be assessed as follows: medical research scale (MRC) for clinical evaluation of muscle strength, handgrip dynamometry, muscle mass evaluation with ultra-sonography, muscle biopsies, maximal inspiratory pressure, tissue oxygen saturation assessed with near infrared spectroscopy (NIRS), muscle microdialysis, electromyography (EMG).

Official Title
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Electrical Muscle Stimulation (EMS), a Preventive and Therapeutic Tool for Critical Illness Polyneuromyopathy (CIPNM)- A Randomized Controlled Parallel Intervention Trial.

Conditions
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Critical Illness Polyneuromyopathy (CIPNM), ICU Acquired Weakness (ICUAW)

Intervention / Treatment
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* Procedure: EMS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: all patients admitted in ICU of Evaggelismos Hospital Exclusion Criteria: age < 18 years pregnancy pre-existing neuromuscular disease (e.g. Gravis) connective tissue disease fractures or skin lesions that do not allow the implementation of EMS BMI > 35 kg/m2 brain death terminal disease length of stay < 48 hours presence of pacemaker

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EMS group<br> | Procedure: EMS<br>* EMS sessions on both lower extremities (quadriceps and peroneus longus) simultaneously.<br>* Other names: Electrical muscle stimulation;|
| No Intervention: control group<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnosis of CIPNM |  | June 2009 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of weaning, time to ICU discharge, muscle mass preservation, muscle strength, muscle properties and structure. |  | June 2011 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ICU, myopathy, neuropathy, EMS, critical illness polyneuromyopathy, NIRS, muscle biopsy, microdialysis, CIPNM