Safety Evaluation of Functional Electrical Stimulation (FES) Cycling in Intensive Care Unit Patients

Study Overview
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Brief Summary
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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.

Official Title
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Study of Feasibility and Safety of Functional Electrical Stimulation (FES) Cycling in Intensive Care Unit Patients

Conditions
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Muscle Weakness

Intervention / Treatment
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* Device: FES cycling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>Patients with FES Cycling | Device: FES cycling<br>* On the patient, three pairs of electrodes will be applied on tibial hamstring, quadriceps and gluteal muscles of each lower limb. Cycloergometer will be installed in passive mode. Then, optimal stimulation intensity for each muscle will be defined. During twenty minutes, neuromuscular electrical stimulation will generate a passive pedaling on cycloergometer.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerance | Number of FES Cycling sessions that must be stopped because of the presence of at least 1 following criteria (these criteria are qualitative (presence or absence) and therefore do not add up): Mean arterial pressure <65mmHg or> 120mmHg, Systolic blood pressure <90 mmHg or> 200 mmHg, Heart rate <50 or> 130 / min Occurrence of atrial or ventricular arrhythmia Respiratory rate > 35 / min, Pulse oxygen saturation <90% Intracranial pressure > 20mmHg. Mean mean arterial velocity measured by transcranial Doppler <30 cm / s | During the FES Cycling session (day 1) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systolic blood pressure | Haemodynamic repercussions of a FES Cycling session measured by Systolic blood pressure | During the FES Cycling session (day 1) | 
| Haemodynamic tolerance Heart rate | Haemodynamic repercussions of a FES Cycling session measured by Heart rate | During the FES Cycling session (day 1) | 
| Cardiac output measured | Haemodynamic repercussions of a FES Cycling session measured by Cardiac output measured in transthoracic echocardiography | During the FES Cycling session (day 1) | 
| Fick equation | Haemodynamic repercussions of a FES Cycling session measured by oxygen consumption according to the Fick equation (cardiac output x (arterial content in O2 - venous content in O2)) | During the FES Cycling session (day 1) | 
| Arterial lactates | Haemodynamic repercussions of a FES Cycling session measured Arterial lactates | During the FES Cycling session (day 1) | 
| Venous oxygen | Haemodynamic repercussions of a FES Cycling session measured by Venous oxygen saturation | During the FES Cycling session (day 1) | 
| Amine dosage | Haemodynamic repercussions of a FES Cycling session measured by Amine dosage | During the FES Cycling session (day 1) | 
| Respiratory tolerance Oxygen saturation | Respiratory repercussions of a FES Cycling session measured by Oxygen saturation | During the FES Cycling session (day 1) | 
| Respiratory tolerance | Respiratory repercussions of a FES Cycling session measured by Respiratory rate | During the FES Cycling session (day 1) | 
| Respiratory rate | Respiratory repercussions of a FES Cycling session measured by PaCO2 and PaO2 | During the FES Cycling session (day 1) | 
| Diastolic cerebral artery | Neurological repercussions of a FES Cycling session measured by diastolic average cerebral artery measured by transcranial Doppler | During the FES Cycling session (day 1) | 
| Pulsatility index | Neurological repercussions of a FES Cycling session measured by Average of pulsatility index, measured by transcranial Doppler. | During the FES Cycling session (day 1) | 
| Intracranial pression | Neurological repercussions of a FES Cycling session measured by, If sensors present, Intracranial pression. | During the FES Cycling session (day 1) | 
| Cerebral perfusion pressure | Neurological repercussions of a FES Cycling session measured by, If sensors present, Cerebral perfusion pressure. | During the FES Cycling session (day 1) | 
| Cerebral tissue oxygen pressure | Neurological repercussions of a FES Cycling session measured by, If sensors present, Cerebral tissue oxygen pressure. | During the FES Cycling session (day 1) | 
| FES cycling installation | FES Cycling technical feasibility measured by installation and uninstallation times Cycloergometer, | After the FES Cycling session (day 1) | 
| FES Cycling technical feasibility | FES Cycling technical feasibility measured by number of persons needed. | After the FES Cycling session (day 1) | 
| Duration of FES Cycling session | FES Cycling technical feasibility measured by total duration of FES Cycling session. | After the FES Cycling session (day 1) | 
| Failure FES Cycling session | FES Cycling technical feasibility measured by number of procedural failures. | After the FES Cycling session (day 1) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intensive care unit acquired muscle weakness, Cycloergometer, Neuromuscular electrical stimulation, FES Cycling