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Trial record 50 of 396 for:    Neuromuscular | Recruiting, Not yet recruiting, Available Studies | "Muscular Diseases"

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

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ClinicalTrials.gov Identifier: NCT03526211
Recruitment Status : Recruiting
First Posted : May 16, 2018
Last Update Posted : July 26, 2018
Sponsor:
Collaborator:
Laboratoire de Physique ENS de Lyon
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne

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.


Condition or disease Intervention/treatment Phase
Muscle Weakness Device: FES cycling Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Study of Feasibility and Safety of Functional Electrical Stimulation (FES) Cycling in Intensive Care Unit Patients
Actual Study Start Date : July 24, 2018
Estimated Primary Completion Date : May 31, 2020
Estimated Study Completion Date : June 7, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Critical Care

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.




Primary Outcome Measures :
  1. Tolerance [ Time Frame: During the FES Cycling session (day 1) ]

    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 :
  1. Systolic blood pressure [ Time Frame: During the FES Cycling session (day 1) ]
    Haemodynamic repercussions of a FES Cycling session measured by Systolic blood pressure

  2. Haemodynamic tolerance Heart rate [ Time Frame: During the FES Cycling session (day 1) ]
    Haemodynamic repercussions of a FES Cycling session measured by Heart rate

  3. Cardiac output measured [ Time Frame: During the FES Cycling session (day 1) ]
    Haemodynamic repercussions of a FES Cycling session measured by Cardiac output measured in transthoracic echocardiography

  4. Fick equation [ Time Frame: During the FES Cycling session (day 1) ]
    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))

  5. Arterial lactates [ Time Frame: During the FES Cycling session (day 1) ]
    Haemodynamic repercussions of a FES Cycling session measured Arterial lactates

  6. Venous oxygen [ Time Frame: During the FES Cycling session (day 1) ]
    Haemodynamic repercussions of a FES Cycling session measured by Venous oxygen saturation

  7. Amine dosage [ Time Frame: During the FES Cycling session (day 1) ]
    Haemodynamic repercussions of a FES Cycling session measured by Amine dosage

  8. Respiratory tolerance Oxygen saturation [ Time Frame: During the FES Cycling session (day 1) ]
    Respiratory repercussions of a FES Cycling session measured by Oxygen saturation

  9. Respiratory tolerance [ Time Frame: During the FES Cycling session (day 1) ]
    Respiratory repercussions of a FES Cycling session measured by Respiratory rate

  10. Respiratory rate [ Time Frame: During the FES Cycling session (day 1) ]
    Respiratory repercussions of a FES Cycling session measured by PaCO2 and PaO2

  11. Diastolic cerebral artery [ Time Frame: During the FES Cycling session (day 1) ]
    Neurological repercussions of a FES Cycling session measured by diastolic average cerebral artery measured by transcranial Doppler

  12. Pulsatility index [ Time Frame: During the FES Cycling session (day 1) ]
    Neurological repercussions of a FES Cycling session measured by Average of pulsatility index, measured by transcranial Doppler.

  13. Intracranial pression [ Time Frame: During the FES Cycling session (day 1) ]
    Neurological repercussions of a FES Cycling session measured by, If sensors present, Intracranial pression.

  14. Cerebral perfusion pressure [ Time Frame: During the FES Cycling session (day 1) ]
    Neurological repercussions of a FES Cycling session measured by, If sensors present, Cerebral perfusion pressure.

  15. Cerebral tissue oxygen pressure [ Time Frame: During the FES Cycling session (day 1) ]
    Neurological repercussions of a FES Cycling session measured by, If sensors present, Cerebral tissue oxygen pressure.

  16. FES cycling installation [ Time Frame: After the FES Cycling session (day 1) ]
    FES Cycling technical feasibility measured by installation and uninstallation times Cycloergometer,

  17. FES Cycling technical feasibility [ Time Frame: After the FES Cycling session (day 1) ]
    FES Cycling technical feasibility measured by number of persons needed.

  18. Duration of FES Cycling session [ Time Frame: After the FES Cycling session (day 1) ]
    FES Cycling technical feasibility measured by total duration of FES Cycling session.

  19. Failure FES Cycling session [ Time Frame: After the FES Cycling session (day 1) ]
    FES Cycling technical feasibility measured by number of procedural failures.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03526211


Contacts
Contact: Béatrice DEYGAS, CRA 0477127655 ext 33 beatrice.deygas@chu-st-etienne.fr
Contact: Anaele PREGNY, CRA Anaele.Pregny@chu-st-etienne.fr

Locations
France
BURNOL Laetitia Recruiting
Saint-etienne, France, 42055
Contact: Anaèle PREGNY       anaele.pregny@chu-st-etienne.fr   
Sub-Investigator: Jérôme MOREL, MD         
Principal Investigator: Laetitia BURNOL, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Laboratoire de Physique ENS de Lyon
Investigators
Principal Investigator: Laetitia BURNOL, MD CHU SAINT-ETIENNE

Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT03526211     History of Changes
Other Study ID Numbers: 18CH005
2018-A00541-54 ( Other Identifier: ANSM )
First Posted: May 16, 2018    Key Record Dates
Last Update Posted: July 26, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
Intensive care unit acquired muscle weakness
Cycloergometer
Neuromuscular electrical stimulation
FES Cycling

Additional relevant MeSH terms:
Muscle Weakness
Paresis
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Pathologic Processes
Signs and Symptoms