Neuropathy Clinical Trial
Official title:
Electro-Neuro-Muscular Stimulation in Hospitalized Intensive Care Patients
Verified date | August 2014 |
Source | University of Thessaly |
Contact | n/a |
Is FDA regulated | No |
Health authority | Greece: Ministry of Health and Welfare |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 25 |
Est. completion date | March 2015 |
Est. primary completion date | March 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 85 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Greece | Icu University Hospital Larissa | Larissa | Thessaly |
Lead Sponsor | Collaborator |
---|---|
University of Thessaly |
Greece,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | ventilator associated pneumonia | presence of ventilator associated pneumonia during 28 days of stay in the ICU | 28 days | No |
Primary | 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 | No |
Secondary | NEUROPATHY | presence of peripheral neuropathy after 12 days of hospitalization in the ICU | 12 days | No |
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