Bed Rest and Muscle Strength in ICU: Interest in the Early Association of NEMS With Cyclo-ergometer Mobilization (AFMPR)

Direction Centrale du Service de Santé des Armées

Status

Unknown

Conditions

Weakness, Muscle

Treatments

Device: Early association of electrical muscle stimulation with cyclo-ergometer

Study type

Interventional

Funder types

Other

Identifiers

NCT03987997

2016RC02

2018-A01330-55 (Registry Identifier)

Details and patient eligibility

About

Muscles atrophy and weakness are common in intensive care units, their origin is multifactorial. Passive then active mobilization with cyclo-ergometer have shown to improve functional abilities and limit muscle weakness among intensive care unit patients. Electrical muscle stimulation should limit the atrophy and muscle weakness in intensive care unit associated with early mobilization.

This study aims to compare the association early cyclo-ergometer mobilization with electrical muscle stimulation versus cyclo-ergometer mobilization only to prevent muscle atrophy and weakness in intensive care unit.

Enrollment

55 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patient affiliated to a social security scheme
Patient hospitalized in intensive care unit for medical or surgical reasons, under assisted ventilation (invasive, non-invasive ventilation or oxygen-therapy at high speed via the Optiflow(r) system delivering a flow between 30 and 60 L.min and a FiO2 between 30 and 100%)
State of the patient deemed stable buy the doctor responsible for the care and allowing the action of the physiotherapist (acts on medical prescription)
Age more than 18 years old (major patient) and less than 75 years old
Duration of mechanical ventilation (invasive or not) less than or equal to 72 hours at the beginning of the inclusion
Predicable duration of stay greater than or equal to 3 days

Exclusion criteria

Impossibility to know the consent of the patient, his legal representative or the person of trust
Patient under safeguard of justice, tutorship or curatorship
Legionnaire not rectified
Cardiac stimulator or defibrillator
Cardiorespiratory state clinically not compatible withe early mobilization
Neurological problems: intracranial pressure > 20 mmHg, presence of ICU acquired neuropathy, pre-existing diagnosis of neuromuscular disease (MS, ALS...), acute stroke, epilepsy
Orthopedic problems: even partial amputation of a lower limb, unstable fracture, suspicion of fracture, non-fixed spinal cord injury, use of a technique that does not allow to comply with postoperative surgical instructions (range of motion, discharge...), untreated deep vein thrombosis, traumatic sequelae to the origin of disabling manifest muscle weakness of a lower limb at admission
Dermatological problems: severe lesions or complex dressing in the lower limbs
Morphological criteria : size < 1.5m, BMI > 35
Confirmed psychiatric illness or severe agitation
Abdominal surgery without protection by compression belt (medical prescription), or too fragile (medical opinion)
Pregnant or lactating women (postpartum is not an exclusion criterion)
Patients over 75 years old
Hemiplegia / sequential hemiparesis
Impossibility to practice electrostimulation on at least one lower limb (manifest muscle weakness of a lower limb at admission (e. g. related to a traumatic sequelae)