Electro-Neuro-Muscular Stimulation in ICU

Neuropathy Clinical Trial

Official title:

Electro-Neuro-Muscular Stimulation in Hospitalized Intensive Care Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02011282
• Other study ID #: CIM-TRIAL
• Status: Completed
• Phase: N/A
• First received: December 9, 2013
• Last updated: March 27, 2015
• Start date: October 2013
• Est. completion date: March 2015

Study information

• Verified date: August 2014
• Source: University of Thessaly
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Ministry of Health and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Myopathy
• Neuropathy

Intervention

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

Locations

Country	Name	City	State
Greece	Icu University Hospital Larissa	Larissa	Thessaly

Sponsors (1)

Lead Sponsor	Collaborator
University of Thessaly

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	ventilator associated pneumonia	presence of ventilator associated pneumonia during 28 days of stay in the ICU	28 days	No
Primary	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	No
Secondary	NEUROPATHY	presence of peripheral neuropathy after 12 days of hospitalization in the ICU	12 days	No