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Electro-Neuro-Muscular Stimulation in ICU

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02011282
Recruitment Status : Completed
First Posted : December 13, 2013
Last Update Posted : March 30, 2015
Sponsor:
Information provided by (Responsible Party):
DEMOSTHENES MAKRIS, University of Thessaly

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Myopathy Neuropathy Other: Patients will receive daily sessions of electro-neuro-stimulation in the quadriceps muscle for 10 days Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Electro-Neuro-Muscular Stimulation in Hospitalized Intensive Care Patients
Study Start Date : October 2013
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Muscle Disorders

Arms and Interventions
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Arm Intervention/treatment
Experimental: Electro-Neuro-Muscular Stimulation
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
No Intervention: Control
Patients in this arm will receive the usual standard treatment


Outcome Measures
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Primary Outcome Measures :
  1. incidence of myopathy [ Time Frame: 12 days ]
    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)


Secondary Outcome Measures :
  1. NEUROPATHY [ Time Frame: 12 days ]
    presence of peripheral neuropathy after 12 days of hospitalization in the ICU


Other Outcome Measures:
  1. ventilator associated pneumonia [ Time Frame: 28 days ]
    presence of ventilator associated pneumonia during 28 days of stay in the ICU


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02011282


Locations
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Greece
Icu University Hospital Larissa
Larissa, Thessaly, Greece, 41110
Sponsors and Collaborators
University of Thessaly
Investigators
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Study Director: EPAMINONDAS ZAKYNTHINOS, PROF University of Thessaly
More Information
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Responsible Party: DEMOSTHENES MAKRIS, ASS. Professor in Critical Care Medicine, University of Thessaly
ClinicalTrials.gov Identifier: NCT02011282    
Other Study ID Numbers: CIM-TRIAL
First Posted: December 13, 2013    Key Record Dates
Last Update Posted: March 30, 2015
Last Verified: August 2014
Keywords provided by DEMOSTHENES MAKRIS, University of Thessaly:
ICU,
MYOPATHY,
NEUROPATHY,
PNEUMONIA
Additional relevant MeSH terms:
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Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases