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Electro-Neuro-Muscular Stimulation in ICU

Primary Purpose

Myopathy, Neuropathy

Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Patients will receive daily sessions of electro-neuro-stimulation in the quadriceps muscle for 10 days
Sponsored by
University of Thessaly
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Myopathy focused on measuring ICU,, MYOPATHY,, NEUROPATHY,, PNEUMONIA

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Icu University Hospital Larissa

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Electro-Neuro-Muscular Stimulation

Control

Arm Description

Patients will receive daily sessions of electrostimulation with a commercially available device (En-Stimulation 4, Netherlands) in the quadriceps muscle for 10 days

Patients in this arm will receive the usual standard treatment

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

NEUROPATHY
presence of peripheral neuropathy after 12 days of hospitalization in the ICU

Full Information

First Posted
December 9, 2013
Last Updated
March 27, 2015
Sponsor
University of Thessaly
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1. Study Identification

Unique Protocol Identification Number
NCT02011282
Brief Title
Electro-Neuro-Muscular Stimulation in ICU
Official Title
Electro-Neuro-Muscular Stimulation in Hospitalized Intensive Care Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Thessaly

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopathy, Neuropathy
Keywords
ICU,, MYOPATHY,, NEUROPATHY,, PNEUMONIA

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Electro-Neuro-Muscular Stimulation
Arm Type
Experimental
Arm Description
Patients will receive daily sessions of electrostimulation with a commercially available device (En-Stimulation 4, Netherlands) in the quadriceps muscle for 10 days
Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients in this arm will receive the usual standard treatment
Intervention Type
Other
Intervention Name(s)
Patients will receive daily sessions of electro-neuro-stimulation in the quadriceps muscle for 10 days
Primary Outcome Measure Information:
Title
incidence of myopathy
Description
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)
Time Frame
12 days
Secondary Outcome Measure Information:
Title
NEUROPATHY
Description
presence of peripheral neuropathy after 12 days of hospitalization in the ICU
Time Frame
12 days
Other Pre-specified Outcome Measures:
Title
ventilator associated pneumonia
Description
presence of ventilator associated pneumonia during 28 days of stay in the ICU
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
EPAMINONDAS ZAKYNTHINOS, PROF
Organizational Affiliation
University of Thessaly
Official's Role
Study Director
Facility Information:
Facility Name
Icu University Hospital Larissa
City
Larissa
State/Province
Thessaly
ZIP/Postal Code
41110
Country
Greece

12. IPD Sharing Statement

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Electro-Neuro-Muscular Stimulation in ICU

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