Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00882830
Recruitment Status : Unknown
Verified March 2015 by Serafim Nanas, University of Athens.
Recruitment status was:  Active, not recruiting
First Posted : April 17, 2009
Last Update Posted : March 13, 2015
Sponsor:
Information provided by (Responsible Party):
Serafim Nanas, University of Athens

Tracking Information
First Submitted Date  ICMJE April 16, 2009
First Posted Date  ICMJE April 17, 2009
Last Update Posted Date March 13, 2015
Study Start Date  ICMJE September 2007
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 16, 2009)
Diagnosis of CIPNM [ Time Frame: June 2009 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 17, 2013)
Duration of weaning, time to ICU discharge, muscle mass preservation, muscle strength, muscle properties and structure. [ Time Frame: June 2011 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 16, 2009)
Duration of weaning, time to ICU discharge, muscle mass preservation, muscle strength, muscle properties and structure. [ Time Frame: December 2009 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Electrical Muscle Stimulation (EMS), a Preventive and Therapeutic Tool for Critical Illness Polyneuromyopathy (CIPNM)
Official Title  ICMJE Electrical Muscle Stimulation (EMS), a Preventive and Therapeutic Tool for Critical Illness Polyneuromyopathy (CIPNM)- A Randomized Controlled Parallel Intervention Trial.
Brief Summary 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.
Detailed Description

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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Critical Illness Polyneuromyopathy (CIPNM)
  • ICU Acquired Weakness (ICUAW)
Intervention  ICMJE Procedure: EMS
EMS sessions on both lower extremities (quadriceps and peroneus longus) simultaneously.
Other Name: Electrical muscle stimulation
Study Arms  ICMJE
  • Experimental: EMS group
    Intervention: Procedure: EMS
  • No Intervention: control group
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: January 17, 2013)
52
Original Estimated Enrollment  ICMJE
 (submitted: April 16, 2009)
80
Estimated Study Completion Date  ICMJE September 2015
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Greece
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00882830
Other Study ID Numbers  ICMJE SNCT050253
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Serafim Nanas, University of Athens
Study Sponsor  ICMJE University of Athens
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Serafim Nanas, MD University of Athens
PRS Account University of Athens
Verification Date March 2015

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