Clinical trial NCT03526211: Safety Evaluation of Functional Electrical Stimulation (FES) Cycling in Intensive Care Unit Patients
Official title: Study of Feasibility and Safety of Functional Electrical Stimulation (FES) Cycling in Intensive Care Unit Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle Weakness
Keywords: Intensive care unit acquired muscle weakness
Cycloergometer
Neuromuscular electrical stimulation
FES Cycling
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
Collaborators: name: Laboratoire de Physique ENS de Lyon
First posted: 2018-05-16
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Intensive care unit acquired muscle weakness (ICUAW), is a common disease which influence rehabilitation, extend mechanical ventilation and length of stay in intensive care unit, and affect quality of life at hospital discharge.

To prevent ICUAW, different strategies of early mobilization are recommended. But all cannot be applied in all ICU patients. Some of them benefit from heavy therapies like circulatory assistance or renal replacement therapy for example, that limit mobilization.

Cycloergometer is a tool that allows continuous passive mobilization in bedridden and even unconscious patients.

Neuromuscular electrical stimulation (NMES) is an alternative that helps preserve muscle mass and limit muscle atrophy.

Early bedside cycle exercise coupled with NMES is an interesting new approach where application of an electrical stimulation along specific motor nerves on each lower limb, generates muscles contractions and pedaling on cycloergometer.

The aim of this study is to evaluate safety and feasibility of this coupled technique called Functional Electrical Stimulation (FES) Cycling, in ICU patients.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Deeply sedated (Riker 1-2) patients, admitted in intensive care unit B of ST-Etienne hospital
* Without curare since 12 hours
* Normothermic or with a controlled fever (central temperature between 36 and 38°C)
* Without haemodynamic instability (mean arterial pressure \> 65mmHg and \< 120mmHg, systolic arterial pressure \> 90mmHg and \< 200mmHg, Norepinephrine \< 4mg/h)
* Without respiratory instability (respiratory rate \< 35/min, pulse oxymetry \> 90%, inspired oxygen fraction \< 60%, PaO2/FiO2 ratio \> 250, Peep \< 10cmH2O, with invasive mechanical ventilation)
* Without neurological instability (diastolic velocities in mean cerebral artery \> 30cm/s, mean velocities \> 50cm/s, pulsatility index \< 1.2, intracranial pressure \< 20mmhg, brain tissue oxygenation tension \> 15mmHg)
* Patient whose family has given informed and written consent to the patient's participation in the study

Exclusion Criteria:

* Pregnant woman,
* Patients with peripheral nerve damage prior to or at the time of measurement
* Curarized patients (non-efficacy of neurostimulation)
* Presence of a catheter in the stimulation zone (femoral artery or vein)
* Patients with lower limb, pelvic or spine fracture
* Patients with continuous renal replacement therapy
* Patients with circulatory assistance
* Patients with wounds in electrodes placement area
* Morbidly obesity with Ideal Body Weight \> 40kg/m2
* Patients with pacemaker
* Lower limb deep vein thrombosis without treatment

Primary outcomes:
measure: Tolerance
timeFrame: During the FES Cycling session (day 1)
Secondary outcomes:
measure: Systolic blood pressure
timeFrame: During the FES Cycling session (day 1)
measure: Haemodynamic tolerance Heart rate
timeFrame: During the FES Cycling session (day 1)
measure: Cardiac output measured
timeFrame: During the FES Cycling session (day 1)
measure: Fick equation
timeFrame: During the FES Cycling session (day 1)
measure: Arterial lactates
timeFrame: During the FES Cycling session (day 1)
measure: Venous oxygen
timeFrame: During the FES Cycling session (day 1)
measure: Amine dosage
timeFrame: During the FES Cycling session (day 1)
measure: Respiratory tolerance Oxygen saturation
timeFrame: During the FES Cycling session (day 1)
measure: Respiratory tolerance
timeFrame: During the FES Cycling session (day 1)
measure: Respiratory rate
timeFrame: During the FES Cycling session (day 1)
measure: Diastolic cerebral artery
timeFrame: During the FES Cycling session (day 1)
measure: Pulsatility index
timeFrame: During the FES Cycling session (day 1)
measure: Intracranial pression
timeFrame: During the FES Cycling session (day 1)
measure: Cerebral perfusion pressure
timeFrame: During the FES Cycling session (day 1)
measure: Cerebral tissue oxygen pressure
timeFrame: During the FES Cycling session (day 1)
measure: FES cycling installation
timeFrame: After the FES Cycling session (day 1)
measure: FES Cycling technical feasibility
timeFrame: After the FES Cycling session (day 1)
measure: Duration of FES Cycling session
timeFrame: After the FES Cycling session (day 1)
measure: Failure FES Cycling session
timeFrame: After the FES Cycling session (day 1)
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: Chu Saint-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Jérôme MOREL, MD
role: PRINCIPAL_INVESTIGATOR
References: