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
  Purpose

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.


Condition Intervention Phase
Critical Illness Polyneuromyopathy (CIPNM)
ICU Acquired Weakness (ICUAW)
Procedure: EMS
Phase 2

Study Type: Interventional
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.

Further study details as provided by University of Athens:

Primary Outcome Measures:
  • Diagnosis of CIPNM [ Time Frame: June 2009 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 52
Study Start Date: September 2007
Estimated Study Completion Date: September 2013
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: EMS group Procedure: EMS
EMS sessions on both lower extremities (quadriceps and peroneus longus) simultaneously.
Other Name: Electrical muscle stimulation
No Intervention: control group

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).

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00882830

Locations
Greece
First Critical Care Unit, Evaggelismos Hospital, School of Medicine, University of Athens
Athens, Greece, 10676
Sponsors and Collaborators
University of Athens
Investigators
Principal Investigator: Serafim Nanas, MD University of Athens
  More Information

Publications:
Responsible Party: Serafim Nanas, MD, University of Athens
ClinicalTrials.gov Identifier: NCT00882830     History of Changes
Other Study ID Numbers: SNCT050253
Study First Received: April 16, 2009
Last Updated: January 17, 2013
Health Authority: Greece: Ethics Committee

Keywords provided by University of Athens:
ICU
myopathy
neuropathy
EMS
critical illness polyneuromyopathy
NIRS
muscle biopsy
microdialysis
CIPNM

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on July 28, 2014