Status:
COMPLETED
Electrical Muscle Stimulation and Bicycling Combined to Early Standard Rehabilitation in the ICU
Lead Sponsor:
Centre Hospitalier Régional d'Orléans
Conditions:
ICU-acquired Muscle Weakness
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Early mobilization (from the first day if possible), first passive and then passive and active, is recommended for critically ill patients in whom it reduces the duration of mechanical ventilation, th...
Eligibility Criteria
Inclusion
- age over 18 yrs
- expected length of stay in the ICU higher than 72 hours
- motor autonomy sufficient for independent ambulation (ass assessed by patient/family/familial practitioner interview
Exclusion
- Opposition expressed by the patient, his/her legal representative or a member of his/her family
- Pregnant woman
- Resuscitated cardiac arrest before inclusion
- Patient carrying a pacemaker or an implantable defibrillator
- Patient under extracorporeal membrane oxygenation
- Severe acute cerebral disease requiring deep sedation
- Brain death
- Guillain-Barré syndrome
- Myasthenia gravis
- Known Dementia than can affect the main endpoint assessment
- Deep venous thrombosis or pulmonary embolism treated for less than 48 hours, or floating clot in femoral, iliac of inferior vena cava veins
- Unstable traumatic injuries of the spine
- Severe skin disease or surgical reasons that either prevent performing electrostimulation or bicycling in the next 2 days, or prevent patient's verticalization or transfer to chair in the next 5 days
- Amputation of a lower limb at the trans-metatarsal level or higher
- Inclusion in another interventional study with muscle strength assessment as the primary endpoint
- Moribund patient
Key Trial Info
Start Date :
July 15 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 24 2016
Estimated Enrollment :
314 Patients enrolled
Trial Details
Trial ID
NCT02185989
Start Date
July 15 2014
End Date
November 24 2016
Last Update
April 13 2017
Active Locations (1)
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1
Centre Hospitalier Régional d'Orléans
Orléans, France, 45000