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OpenTrials
Completed

NCT Number: NCT02011282

Electro-Neuro-Muscular Stimulation in ICU

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Icu University Hospital Larissa

Larissa, Thessaly, 41110, Greece

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other

Primary outcomes

  1. incidence of myopathy

    Time frame: 12 days

    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 outcomes

  1. NEUROPATHY

    Time frame: 12 days

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

Other outcomes

  1. ventilator associated pneumonia

    Time frame: 28 days

    presence of ventilator associated pneumonia during 28 days of stay in the ICU

Sponsors and collaborators

Lead sponsor

University of Thessaly

Other

Registry information

Official study title

Electro-Neuro-Muscular Stimulation in Hospitalized Intensive Care Patients

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Dec 13, 2013
Registry last updated
Mar 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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