Electrical Muscle Stimulation (EMS), a Preventive and Therapeutic Tool for Critical Illness Polyneuromyopathy (CIPNM)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Serafim Nanas, University of Athens
ClinicalTrials.gov Identifier:
NCT00882830
First received: April 16, 2009
Last updated: January 17, 2013
Last verified: January 2013

April 16, 2009
January 17, 2013
September 2007
June 2009   (final data collection date for primary outcome measure)
Diagnosis of CIPNM [ Time Frame: June 2009 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00882830 on ClinicalTrials.gov Archive Site
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 ]
Duration of weaning, time to ICU discharge, muscle mass preservation, muscle strength, muscle properties and structure. [ Time Frame: December 2009 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Electrical Muscle Stimulation (EMS), a Preventive and Therapeutic Tool for Critical Illness Polyneuromyopathy (CIPNM)
Electrical Muscle Stimulation (EMS), a Preventive and Therapeutic Tool for Critical Illness Polyneuromyopathy (CIPNM)- A Randomized Controlled Parallel Intervention Trial.

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.

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).

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Critical Illness Polyneuromyopathy (CIPNM)
  • ICU Acquired Weakness (ICUAW)
Procedure: EMS
EMS sessions on both lower extremities (quadriceps and peroneus longus) simultaneously.
Other Name: Electrical muscle stimulation
  • Experimental: EMS group
    Intervention: Procedure: EMS
  • No Intervention: control group

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
52
September 2013
June 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • all patients admitted in ICU of Evaggelismos Hospital

Exclusion Criteria:

  • age < 18 years
  • pregnancy
  • pre-existing neuromuscular disease (e.g. Gravis)
  • connective tissue disease
  • fractures or skin lesions that do not allow the implementation of EMS
  • BMI > 35 kg/m2
  • brain death
  • terminal disease
  • length of stay < 48 hours
  • presence of pacemaker
Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
Greece
 
NCT00882830
SNCT050253
No
Serafim Nanas, University of Athens
University of Athens
Not Provided
Principal Investigator: Serafim Nanas, MD University of Athens
University of Athens
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP