Electro-Neuro-Muscular Stimulation in ICU

NCT02011282 | Completed DMC

• 1 other identifier: CIM-TRIAL
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Myopathy; Neuropathy

Keywords

ICU,; MYOPATHY,; NEUROPATHY,; PNEUMONIA

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• NEUROPATHY

  12 days

Other Outcomes (1)

• ventilator associated pneumonia

  28 days

Study Arms (2)

Electro-Neuro-Muscular Stimulation

EXPERIMENTAL

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

Control

NO INTERVENTION

Patients in this arm will receive the usual standard treatment

Interventions

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

Electro-Neuro-Muscular Stimulation

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged\>18 years old and \<85 years old, hospitalized in the ICU for at least 96 hours

You may not qualify if:

• pregnancy, autoimmune disease, pre-existing known neuromuscular diseases, presence of bone fractures on the lower extremities, use of corticoids

Sponsors & Collaborators

• University of Thessaly: lead

Study Sites (1)

Icu University Hospital Larissa

Larissa, Thessaly, 41110, Greece

Location

MeSH Terms

Conditions

Muscular Diseases; Pneumonia

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• EPAMINONDAS ZAKYNTHINOS, PROF

  University of Thessaly

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ASS. Professor in Critical Care Medicine

Study Record Dates

• First Submitted: December 9, 2013
• First Posted: December 13, 2013
• Study Start: October 1, 2013
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: March 30, 2015

Record last verified: 2014-08

Locations

GR (1)