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

• Status: Completed
• Conditions: Muscle Weakness
• Intervention / Treatment: Device: FES cycling

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Saint-Étienne, France, 42055
    • CHU Saint-Etienne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Experimental; Patients with FES Cycling	Device: FES cycling; 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.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Collaborators: Laboratoire de Physique ENS de Lyon

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 24, 2018
• Primary Completion (ACTUAL): June 18, 2019
• Study Completion (ACTUAL): June 18, 2019

Study Registration Dates

• First Submitted: March 28, 2018
• First Submitted That Met QC Criteria: May 3, 2018
• First Posted (ACTUAL): May 16, 2018

Study Record Updates

• Last Update Posted (ACTUAL): July 15, 2019
• Last Update Submitted That Met QC Criteria: July 12, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: Neuromuscular electrical stimulation; Intensive care unit acquired muscle weakness; Cycloergometer; FES Cycling
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Weakness; Paresis
• Other Study ID Numbers: 18CH005; 2018-A00541-54 (OTHER: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No