Myopathy, Neuropathy
Conditions
Keywords
ICU,, MYOPATHY,, NEUROPATHY,, PNEUMONIA
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.
Interventions
OTHERPatients will receive daily sessions of electro-neuro-stimulation in the quadriceps muscle for 10 days
Sponsors
University of Thessaly
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| incidence of myopathy | 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
| Measure | Time frame | Description |
|---|---|---|
| NEUROPATHY | 12 days | presence of peripheral neuropathy after 12 days of hospitalization in the ICU |
Other
| Measure | Time frame | Description |
|---|---|---|
| ventilator associated pneumonia | 28 days | presence of ventilator associated pneumonia during 28 days of stay in the ICU |
Countries
Greece
Outcome results
None listed