Electro-Neuro-Muscular Stimulation in ICU

Electro-Neuro-Muscular Stimulation in Hospitalized Intensive Care Patients

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.

Study Overview

• Status: Completed
• Conditions: Neuropathy; Myopathy
• Intervention / Treatment: Other: Patients will receive daily sessions of electro-neuro-stimulation in the quadriceps muscle for 10 days

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Thessaly
    • Larissa, Thessaly, Greece, 41110
      • Icu University Hospital Larissa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
NEUROPATHY	presence of peripheral neuropathy after 12 days of hospitalization in the ICU	12 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
ventilator associated pneumonia	presence of ventilator associated pneumonia during 28 days of stay in the ICU	28 days

Collaborators and Investigators

• Sponsor: University of Thessaly
• Investigators: Study Director: EPAMINONDAS ZAKYNTHINOS, PROF, University of Thessaly

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: December 9, 2013
• First Submitted That Met QC Criteria: December 9, 2013
• First Posted (Estimate): December 13, 2013

Study Record Updates

• Last Update Posted (Estimate): March 30, 2015
• Last Update Submitted That Met QC Criteria: March 27, 2015
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Keywords: PNEUMONIA; ICU,; MYOPATHY,; NEUROPATHY,
• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Muscular Diseases
• Other Study ID Numbers: CIM-TRIAL