Electrical Muscle Stimulation (EMS), a Preventive and Therapeutic Tool for Critical Illness Polyneuromyopathy (CIPNM)
Recruitment status was Active, not recruiting
The purpose of this study is to investigate the role of EMS as a preventive and therapeutic tool of CIPNM. The investigators hypothesized that EMS will prevent the development of CIPNM or have a beneficial role as a therapeutic means in case of CIPNM appearance.
Critical Illness Polyneuromyopathy (CIPNM)
ICU Acquired Weakness (ICUAW)
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Electrical Muscle Stimulation (EMS), a Preventive and Therapeutic Tool for Critical Illness Polyneuromyopathy (CIPNM)- A Randomized Controlled Parallel Intervention Trial.|
- Diagnosis of CIPNM [ Time Frame: June 2009 ] [ Designated as safety issue: No ]
- Duration of weaning, time to ICU discharge, muscle mass preservation, muscle strength, muscle properties and structure. [ Time Frame: June 2011 ] [ Designated as safety issue: No ]
|Study Start Date:||September 2007|
|Estimated Study Completion Date:||September 2013|
|Primary Completion Date:||June 2009 (Final data collection date for primary outcome measure)|
|Experimental: EMS group||
EMS sessions on both lower extremities (quadriceps and peroneus longus) simultaneously.
Other Name: Electrical muscle stimulation
|No Intervention: control group|
CIPNM is one of the most frequent clinical problems encountered in a general ICU. Inflicted patients are characterized by generalized muscle weakness, areflexia, delayed weaning from mechanical ventilation and subsequent increased duration of ICU stay. So far, no therapeutic or preventive tool has been proposed for CIPNM.
Electrical muscle stimulation (EMS) has been proposed as an alternative exercise modality in patients with severe chronic obstructive pulmonary disease and chronic heart failure, who cannot perform active exercise. The role of EMS in ICU patients has not been evaluated so far.
We designed a randomized intervention study to assess the efficacy of EMS, as a preventive or therapeutic tool in CIPNM. The study consists of two cohorts. In the preventive cohort, patients with Apache II admission score ≥ 13, after stratified (age, gender) randomization, are assigned on the second day after admission to the EMS group or to the control group. In the observation cohort, patients with Apache II < 13 are followed clinically until interruption of sedation. Patients who regain consciousness and are cooperative are assessed clinically for CIPNM. If they are diagnosed with CIPNM, they undergo stratified randomization (age, gender, diabetes mellitus, malignancy) to EMS group or to the control group. EMS will be applied to both lower extremities of the EMS-group simultaneously (quadriceps femoris muscle and peroneus longus) on a daily basis. EMS sessions will continue until patient discharge or death. EMS sessions are supplementary to standard physiotherapy practice applied to all ICU patients.
Primary end point is the diagnosis of CIPNM. Secondary end points are 1) the duration of weaning from the ventilator, 2) time to ICU discharge, 3) muscle mass preservation, 4) muscle strength, 5) muscle properties and structure. The primary and secondary endpoints will be assessed as follows: medical research scale (MRC) for clinical evaluation of muscle strength, handgrip dynamometry, muscle mass evaluation with ultra-sonography, muscle biopsies, maximal inspiratory pressure, tissue oxygen saturation assessed with near infrared spectroscopy (NIRS), muscle microdialysis, electromyography (EMG).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00882830
|First Critical Care Unit, Evaggelismos Hospital, School of Medicine, University of Athens|
|Athens, Greece, 10676|
|Principal Investigator:||Serafim Nanas, MD||University of Athens|