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

Primary Purpose

Muscle Weakness

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
FES cycling
Sponsored by
Centre Hospitalier Universitaire de Saint Etienne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Muscle Weakness focused on measuring Intensive care unit acquired muscle weakness, Cycloergometer, Neuromuscular electrical stimulation, FES Cycling

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chu Saint-Etienne

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental

Arm Description

Patients with FES Cycling

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Systolic blood pressure
Haemodynamic repercussions of a FES Cycling session measured by Systolic blood pressure
Haemodynamic tolerance Heart rate
Haemodynamic repercussions of a FES Cycling session measured by Heart rate
Cardiac output measured
Haemodynamic repercussions of a FES Cycling session measured by Cardiac output measured in transthoracic echocardiography
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))
Arterial lactates
Haemodynamic repercussions of a FES Cycling session measured Arterial lactates
Venous oxygen
Haemodynamic repercussions of a FES Cycling session measured by Venous oxygen saturation
Amine dosage
Haemodynamic repercussions of a FES Cycling session measured by Amine dosage
Respiratory tolerance Oxygen saturation
Respiratory repercussions of a FES Cycling session measured by Oxygen saturation
Respiratory tolerance
Respiratory repercussions of a FES Cycling session measured by Respiratory rate
Respiratory rate
Respiratory repercussions of a FES Cycling session measured by PaCO2 and PaO2
Diastolic cerebral artery
Neurological repercussions of a FES Cycling session measured by diastolic average cerebral artery measured by transcranial Doppler
Pulsatility index
Neurological repercussions of a FES Cycling session measured by Average of pulsatility index, measured by transcranial Doppler.
Intracranial pression
Neurological repercussions of a FES Cycling session measured by, If sensors present, Intracranial pression.
Cerebral perfusion pressure
Neurological repercussions of a FES Cycling session measured by, If sensors present, Cerebral perfusion pressure.
Cerebral tissue oxygen pressure
Neurological repercussions of a FES Cycling session measured by, If sensors present, Cerebral tissue oxygen pressure.
FES cycling installation
FES Cycling technical feasibility measured by installation and uninstallation times Cycloergometer,
FES Cycling technical feasibility
FES Cycling technical feasibility measured by number of persons needed.
Duration of FES Cycling session
FES Cycling technical feasibility measured by total duration of FES Cycling session.
Failure FES Cycling session
FES Cycling technical feasibility measured by number of procedural failures.

Full Information

First Posted
March 28, 2018
Last Updated
July 12, 2019
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Collaborators
Laboratoire de Physique ENS de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT03526211
Brief Title
Safety Evaluation of Functional Electrical Stimulation (FES) Cycling in Intensive Care Unit Patients
Acronym
FES Cycling
Official Title
Study of Feasibility and Safety of Functional Electrical Stimulation (FES) Cycling in Intensive Care Unit Patients
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
July 24, 2018 (Actual)
Primary Completion Date
June 18, 2019 (Actual)
Study Completion Date
June 18, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Collaborators
Laboratoire de Physique ENS de Lyon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Weakness
Keywords
Intensive care unit acquired muscle weakness, Cycloergometer, Neuromuscular electrical stimulation, FES Cycling

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
Patients with FES Cycling
Intervention Type
Device
Intervention Name(s)
FES cycling
Intervention Description
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.
Primary Outcome Measure Information:
Title
Tolerance
Description
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
Time Frame
During the FES Cycling session (day 1)
Secondary Outcome Measure Information:
Title
Systolic blood pressure
Description
Haemodynamic repercussions of a FES Cycling session measured by Systolic blood pressure
Time Frame
During the FES Cycling session (day 1)
Title
Haemodynamic tolerance Heart rate
Description
Haemodynamic repercussions of a FES Cycling session measured by Heart rate
Time Frame
During the FES Cycling session (day 1)
Title
Cardiac output measured
Description
Haemodynamic repercussions of a FES Cycling session measured by Cardiac output measured in transthoracic echocardiography
Time Frame
During the FES Cycling session (day 1)
Title
Fick equation
Description
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))
Time Frame
During the FES Cycling session (day 1)
Title
Arterial lactates
Description
Haemodynamic repercussions of a FES Cycling session measured Arterial lactates
Time Frame
During the FES Cycling session (day 1)
Title
Venous oxygen
Description
Haemodynamic repercussions of a FES Cycling session measured by Venous oxygen saturation
Time Frame
During the FES Cycling session (day 1)
Title
Amine dosage
Description
Haemodynamic repercussions of a FES Cycling session measured by Amine dosage
Time Frame
During the FES Cycling session (day 1)
Title
Respiratory tolerance Oxygen saturation
Description
Respiratory repercussions of a FES Cycling session measured by Oxygen saturation
Time Frame
During the FES Cycling session (day 1)
Title
Respiratory tolerance
Description
Respiratory repercussions of a FES Cycling session measured by Respiratory rate
Time Frame
During the FES Cycling session (day 1)
Title
Respiratory rate
Description
Respiratory repercussions of a FES Cycling session measured by PaCO2 and PaO2
Time Frame
During the FES Cycling session (day 1)
Title
Diastolic cerebral artery
Description
Neurological repercussions of a FES Cycling session measured by diastolic average cerebral artery measured by transcranial Doppler
Time Frame
During the FES Cycling session (day 1)
Title
Pulsatility index
Description
Neurological repercussions of a FES Cycling session measured by Average of pulsatility index, measured by transcranial Doppler.
Time Frame
During the FES Cycling session (day 1)
Title
Intracranial pression
Description
Neurological repercussions of a FES Cycling session measured by, If sensors present, Intracranial pression.
Time Frame
During the FES Cycling session (day 1)
Title
Cerebral perfusion pressure
Description
Neurological repercussions of a FES Cycling session measured by, If sensors present, Cerebral perfusion pressure.
Time Frame
During the FES Cycling session (day 1)
Title
Cerebral tissue oxygen pressure
Description
Neurological repercussions of a FES Cycling session measured by, If sensors present, Cerebral tissue oxygen pressure.
Time Frame
During the FES Cycling session (day 1)
Title
FES cycling installation
Description
FES Cycling technical feasibility measured by installation and uninstallation times Cycloergometer,
Time Frame
After the FES Cycling session (day 1)
Title
FES Cycling technical feasibility
Description
FES Cycling technical feasibility measured by number of persons needed.
Time Frame
After the FES Cycling session (day 1)
Title
Duration of FES Cycling session
Description
FES Cycling technical feasibility measured by total duration of FES Cycling session.
Time Frame
After the FES Cycling session (day 1)
Title
Failure FES Cycling session
Description
FES Cycling technical feasibility measured by number of procedural failures.
Time Frame
After the FES Cycling session (day 1)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jérôme MOREL, MD
Organizational Affiliation
CHU SAINT-ETIENNE
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chu Saint-Etienne
City
Saint-Étienne
ZIP/Postal Code
42055
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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