- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03526211
Safety Evaluation of Functional Electrical Stimulation (FES) Cycling in Intensive Care Unit Patients (FES Cycling)
Study of Feasibility and Safety of Functional Electrical Stimulation (FES) Cycling in Intensive Care Unit Patients
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.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Saint-Étienne, France, 42055
- CHU SAINT-ETIENNE
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: Experimental
Patients with FES Cycling
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tolerance
Time Frame: During the FES Cycling session (day 1)
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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):
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During the FES Cycling session (day 1)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Systolic blood pressure
Time Frame: During the FES Cycling session (day 1)
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Haemodynamic repercussions of a FES Cycling session measured by Systolic blood pressure
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During the FES Cycling session (day 1)
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Haemodynamic tolerance Heart rate
Time Frame: During the FES Cycling session (day 1)
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Haemodynamic repercussions of a FES Cycling session measured by Heart rate
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During the FES Cycling session (day 1)
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Cardiac output measured
Time Frame: During the FES Cycling session (day 1)
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Haemodynamic repercussions of a FES Cycling session measured by Cardiac output measured in transthoracic echocardiography
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During the FES Cycling session (day 1)
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Fick equation
Time Frame: During the FES Cycling session (day 1)
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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))
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During the FES Cycling session (day 1)
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Arterial lactates
Time Frame: During the FES Cycling session (day 1)
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Haemodynamic repercussions of a FES Cycling session measured Arterial lactates
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During the FES Cycling session (day 1)
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Venous oxygen
Time Frame: During the FES Cycling session (day 1)
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Haemodynamic repercussions of a FES Cycling session measured by Venous oxygen saturation
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During the FES Cycling session (day 1)
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Amine dosage
Time Frame: During the FES Cycling session (day 1)
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Haemodynamic repercussions of a FES Cycling session measured by Amine dosage
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During the FES Cycling session (day 1)
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Respiratory tolerance Oxygen saturation
Time Frame: During the FES Cycling session (day 1)
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Respiratory repercussions of a FES Cycling session measured by Oxygen saturation
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During the FES Cycling session (day 1)
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Respiratory tolerance
Time Frame: During the FES Cycling session (day 1)
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Respiratory repercussions of a FES Cycling session measured by Respiratory rate
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During the FES Cycling session (day 1)
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Respiratory rate
Time Frame: During the FES Cycling session (day 1)
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Respiratory repercussions of a FES Cycling session measured by PaCO2 and PaO2
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During the FES Cycling session (day 1)
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Diastolic cerebral artery
Time Frame: During the FES Cycling session (day 1)
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Neurological repercussions of a FES Cycling session measured by diastolic average cerebral artery measured by transcranial Doppler
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During the FES Cycling session (day 1)
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Pulsatility index
Time Frame: During the FES Cycling session (day 1)
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Neurological repercussions of a FES Cycling session measured by Average of pulsatility index, measured by transcranial Doppler.
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During the FES Cycling session (day 1)
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Intracranial pression
Time Frame: During the FES Cycling session (day 1)
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Neurological repercussions of a FES Cycling session measured by, If sensors present, Intracranial pression.
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During the FES Cycling session (day 1)
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Cerebral perfusion pressure
Time Frame: During the FES Cycling session (day 1)
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Neurological repercussions of a FES Cycling session measured by, If sensors present, Cerebral perfusion pressure.
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During the FES Cycling session (day 1)
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Cerebral tissue oxygen pressure
Time Frame: During the FES Cycling session (day 1)
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Neurological repercussions of a FES Cycling session measured by, If sensors present, Cerebral tissue oxygen pressure.
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During the FES Cycling session (day 1)
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FES cycling installation
Time Frame: After the FES Cycling session (day 1)
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FES Cycling technical feasibility measured by installation and uninstallation times Cycloergometer,
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After the FES Cycling session (day 1)
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FES Cycling technical feasibility
Time Frame: After the FES Cycling session (day 1)
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FES Cycling technical feasibility measured by number of persons needed.
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After the FES Cycling session (day 1)
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Duration of FES Cycling session
Time Frame: After the FES Cycling session (day 1)
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FES Cycling technical feasibility measured by total duration of FES Cycling session.
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After the FES Cycling session (day 1)
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Failure FES Cycling session
Time Frame: After the FES Cycling session (day 1)
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FES Cycling technical feasibility measured by number of procedural failures.
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After the FES Cycling session (day 1)
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Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18CH005
- 2018-A00541-54 (OTHER: ANSM)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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