Polyneuropathy, Critical Illness
Conditions
Keywords
Critical illness polyneuropathy, Neuromuscular Electrical Stimulation
Brief summary
The purpose of this study is to determine whether early neuromuscular electrical stimulation is effective in the prevention of neuromuscular weakness in critical ill patients.
Detailed description
Randomized, controlled study of early electrical neurostimulation (vs sham) in critically ill patients.
Interventions
DEVICENeuromuscular electrical stimulation
NEMS is delivered bilaterally to the quadriceps femoris muscle using a portable battery-powered stimulator (Rehab 400, Cefar Compex, France). The electrodes are placed on the motor points of vastus medialis and vastus lateralis muscles. Electrical stimuli of 45Hz (pulse width: 380 µseconds; 6 seconds on with 1.5 second rise time; and 0.75 seconds fall time.; 5 seconds off). The current is adjusted to ensure maximum tolerable muscle contraction The protocol is applied twice daily for 25 minutes, five days a week.
DEVICESham control
No electrostimulation
Sponsors
Fondation Paul Bennetot
Assistance Publique - Hôpitaux de Paris
Institut Mutualiste Montsouris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All patient * Aged of 18 or more * With an intended ICU stay of at least 72 hours * Mechanically ventilated
Exclusion criteria
* Age less than 18 years * Pregnant women * Preexisting neuromuscular disease * Patient bearing a pace maker or an implantable defibrillator. * Poly traumatism and/or leg fracture. * End stage disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Medical resuscitation council (MRC) score | up to 25 months. From date of randomization to the date of ICU discharge |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total duration of mechanical ventilation (days) | up to 25 months. From date of randomization to the date of ICU discharge | — |
| Length of ICU stay and hospital stay. | up to 25 months. From date of randomization to the date of ICU discharge or hospital discharge | — |
| Type of hospital discharge | up to 25 months. From date of randomization to the date of hospital discharge | (alive/deceased/rehabilitation/home...) |
Countries
France
Contacts
Primary ContactChristian Lamer, MD
Backup ContactCeline Menez, PT
Outcome results
None listed