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

Critical Illness Polyneuromyopathy (CIPNM) Clinical Trial

Official title:

Electrical Muscle Stimulation (EMS), a Preventive and Therapeutic Tool for Critical Illness Polyneuromyopathy (CIPNM)- A Randomized Controlled Parallel Intervention Trial.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00882830
• Other study ID #: SNCT050253
• Status: Active, not recruiting
• Phase: Phase 2
• First received: April 16, 2009
• Last updated: March 12, 2015
• Start date: September 2007
• Est. completion date: September 2015

Study information

• Verified date: March 2015
• Source: University of Athens
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 52
• Est. completion date: September 2015
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Critical Illness
• Critical Illness Polyneuromyopathy (CIPNM)
• ICU Acquired Weakness (ICUAW)

Intervention

Procedure:
• EMS
EMS sessions on both lower extremities (quadriceps and peroneus longus) simultaneously.

Locations

Country	Name	City	State
Greece	First Critical Care Unit, Evaggelismos Hospital, School of Medicine, University of Athens	Athens

Sponsors (1)

Lead Sponsor	Collaborator
University of Athens

Country where clinical trial is conducted

Greece, 

References & Publications (5)

Gerovasili V, Stefanidis K, Vitzilaios K, Karatzanos E, Politis P, Koroneos A, Chatzimichail A, Routsi C, Roussos C, Nanas S. Electrical muscle stimulation preserves the muscle mass of critically ill patients: a randomized study. Crit Care. 2009;13(5):R16 — View Citation

Gerovasili V, Tripodaki E, Karatzanos E, Pitsolis T, Markaki V, Zervakis D, Routsi C, Roussos C, Nanas S. Short-term systemic effect of electrical muscle stimulation in critically ill patients. Chest. 2009 Nov;136(5):1249-56. doi: 10.1378/chest.08-2888. E — View Citation

Karatzanos E, Gerovasili V, Zervakis D, Tripodaki ES, Apostolou K, Vasileiadis I, Papadopoulos E, Mitsiou G, Tsimpouki D, Routsi C, Nanas S. Electrical muscle stimulation: an effective form of exercise and early mobilization to preserve muscle strength in — View Citation

Routsi C, Gerovasili V, Vasileiadis I, Karatzanos E, Pitsolis T, Tripodaki E, Markaki V, Zervakis D, Nanas S. Electrical muscle stimulation prevents critical illness polyneuromyopathy: a randomized parallel intervention trial. Crit Care. 2010;14(2):R74. d — View Citation

Tzanis G, Vasileiadis I, Zervakis D, Karatzanos E, Dimopoulos S, Pitsolis T, Tripodaki E, Gerovasili V, Routsi C, Nanas S. Maximum inspiratory pressure, a surrogate parameter for the assessment of ICU-acquired weakness. BMC Anesthesiol. 2011 Jun 26;11:14. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnosis of CIPNM		June 2009	No
Secondary	Duration of weaning, time to ICU discharge, muscle mass preservation, muscle strength, muscle properties and structure.		June 2011	No