Electrical Muscle Stimulation in the Development of Acquired Weakness in Patients With Severe Sepsis and Septic Shock

Study Overview
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Brief Summary
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The aim of this study is to compare the effect of EMS and conventional physical therapy on strength and muscle mass and development in adult patients with severe sepsis and septic shock.

Detailed Description
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Septic patients are at high risk of developing intensive care unit acquired weakness (ICUAW). Electrical muscle stimulation (EMS) has become an alternative exercise for critical and non-cooperative patients.

Official Title
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Electrical Muscle Stimulation in the Development of Acquired Weakness in the Intensive Care Unit in Adult Patients With Severe Sepsis and Septic Shock at the Clinic Hospital of the Univerisity of Chile: Results of a Pilot Randomized Study

Conditions
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Polyneuropathies, Septic Shock, Muscle Weakness

Intervention / Treatment
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* Device: electrical muscle stimulation
* Procedure: conventional physical therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects admitted to the ICU of the HCUCH in the period between November 2016 to August 2017 and January to June 2018 Diagnosis of severe sepsis or septic shock More than 48 hours in VMI With sedation and / or neuromuscular blockade Autovalent prior to admission to the ICU Exclusion Criteria: Subjects from other hospitals / clinics or units of the hospital Multiple trauma Previous neuromuscular pathology Pacemaker users Pregnant women BMI> 35 Epilepsy Those who have refused to sign informed consent

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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Accepts Healthy Volunteers

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: electrical muscle stimulation<br>conventional physical therapy according to the adaptation of the Start to move protocol of Gosselink et al. plus electrical muscle stimulation: The parameters used in biceps were: 35 Hz, 250 μs and in quadriceps were: 50 Hz, 400 μs. In both, biphasic wave was used, 45 minutes of total work, 5 seconds of contraction and 10 seconds of relaxation and the intensity was adjusted to present a visible contraction | Device: electrical muscle stimulation<br>* electrical muscle stimulation: The parameters used in biceps were: 35 Hz, 250 μs and in quadriceps were: 50 Hz, 400 μs. In both, biphasic wave was used, 45 minutes of total work, 5 seconds of contraction and 10 seconds of relaxation and the intensity was adjusted to present a visible contraction<br>Procedure: conventional physical therapy<br>* conventional physical therapy according to the adaptation of the Start to move protocol of Gosselink et al<br>|
| Active Comparator: conventional physical therapy<br>conventional physical therapy according to the adaptation of the Start to move protocol of Gosselink et al | Procedure: conventional physical therapy<br>* conventional physical therapy according to the adaptation of the Start to move protocol of Gosselink et al<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intensive care unit acquired weakness | Medical research council sum score: Bilateral testing of 6 muscle groups (shoulder abduction, elbow flexion, wrist extension, hip flexion, knee extension, and ankle dorsiflexion). Ranges from 0 (total paralysis) to 60 (normal strength). Score under 48 points indicates intensive care unit acquired weakness | at awakening of the subject, an average of 8 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| muscle strength | Medical research council sum score: Bilateral testing of 6 muscle groups (shoulder abduction, elbow flexion, wrist extension, hip flexion, knee extension, and ankle dorsiflexion). Ranges from 0 (total paralysis) to 60 (normal strength). | at awakening of the subject, an average of 8 days | 
| muscle mass | ultrasonography | at ICU admission of the subjet, at 48 hours post admission and at awakening of the subject, an average of 8 days | 
| maximum inspiratory pressure | maximum inspiratory pressure | at awakening of the subject, an average of 8 days | 
| days of mechanical ventilation | number of days wirh mechanical ventilation | an average of 11 days | 
| Number of Participants with weaning failure | Number of Participants who presented reintubation | 48 hours post extubation day | 
| days of ICU stay | number of days in ICU | at ICU discharge, an average of 18 days | 
| mortality at 28 days | mortality | at 28 days post ICU admission | 
| gait ability at hospital discharge | presence or not of gait ability | at hospital discharge, an averange of 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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polyneuropathies, muscle weakness, sepsis, septic shock, electrical stimulation, intensive care unit