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Completed

NCT Number: NCT03526211

Safety Evaluation 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.

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Key information

Conditions

Muscle Weakness Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chu Saint-Etienne

Saint-Etienne, 42055, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FES cycling

Device

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Collaborators

  • Laboratoire de Physique ENS de Lyon

Registry information

Official study title

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

Acronym: FES Cycling

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 16, 2018
Registry last updated
Jul 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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