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Electro-Neuro-Muscular Stimulation in ICU

U

University of Thessaly

Status

Completed

Conditions

Myopathy
Neuropathy

Treatments

Other: Patients will receive daily sessions of electro-neuro-stimulation in the quadriceps muscle for 10 days

Study type

Interventional

Funder types

Other

Identifiers

NCT02011282
CIM-TRIAL

Details and patient eligibility

About

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.

Enrollment

25 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

25 participants in 2 patient groups

Electro-Neuro-Muscular Stimulation
Experimental group
Description:
Patients will receive daily sessions of electrostimulation with a commercially available device (En-Stimulation 4, Netherlands) in the quadriceps muscle for 10 days
Treatment:
Other: Patients will receive daily sessions of electro-neuro-stimulation in the quadriceps muscle for 10 days
Control
No Intervention group
Description:
Patients in this arm will receive the usual standard treatment

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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