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