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Muscle WeaknessFES CyclingNCT03526211

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

A study testing FES cycling in people with Muscle Weakness, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Muscle Weakness
What is being tested?
FES cycling
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteFrance
Study dates
24 Jul 2018to 18 Jun 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

France1 site

  • Chu Saint-Etienne

    Saint-Etienne, 42055

Other trials in France

About this study

Official title: 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.

Read more

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.

Conditions
Muscle Weakness
Being tested
FES cycling
Keywords
Intensive care unit acquired muscle weakness, Cycloergometer, Neuromuscular electrical stimulation, FES Cycling
Medical subject headings
Muscle Weakness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FES cyclingDevice

    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.

Study groups in NCT03526211
Study groupRoleWhat they receive
ExperimentalExperimentalPatients with FES Cycling
Receives: Device: FES cycling

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: During the FES Cycling session (day 1)

Secondary outcomes (19)

  1. Systolic blood pressure

    Haemodynamic repercussions of a FES Cycling session measured by Systolic blood pressure

    Measured: During the FES Cycling session (day 1)

  2. Haemodynamic tolerance Heart rate

    Haemodynamic repercussions of a FES Cycling session measured by Heart rate

    Measured: During the FES Cycling session (day 1)

  3. Cardiac output measured

    Haemodynamic repercussions of a FES Cycling session measured by Cardiac output measured in transthoracic echocardiography

    Measured: During the FES Cycling session (day 1)

  4. 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))

    Measured: During the FES Cycling session (day 1)

  5. Arterial lactates

    Haemodynamic repercussions of a FES Cycling session measured Arterial lactates

    Measured: During the FES Cycling session (day 1)

  6. Venous oxygen

    Haemodynamic repercussions of a FES Cycling session measured by Venous oxygen saturation

    Measured: During the FES Cycling session (day 1)

  7. Amine dosage

    Haemodynamic repercussions of a FES Cycling session measured by Amine dosage

    Measured: During the FES Cycling session (day 1)

  8. Respiratory tolerance Oxygen saturation

    Respiratory repercussions of a FES Cycling session measured by Oxygen saturation

    Measured: During the FES Cycling session (day 1)

  9. Respiratory tolerance

    Respiratory repercussions of a FES Cycling session measured by Respiratory rate

    Measured: During the FES Cycling session (day 1)

  10. Respiratory rate

    Respiratory repercussions of a FES Cycling session measured by PaCO2 and PaO2

    Measured: During the FES Cycling session (day 1)

  11. Diastolic cerebral artery

    Neurological repercussions of a FES Cycling session measured by diastolic average cerebral artery measured by transcranial Doppler

    Measured: During the FES Cycling session (day 1)

  12. Pulsatility index

    Neurological repercussions of a FES Cycling session measured by Average of pulsatility index, measured by transcranial Doppler.

    Measured: During the FES Cycling session (day 1)

  13. Intracranial pression

    Neurological repercussions of a FES Cycling session measured by, If sensors present, Intracranial pression.

    Measured: During the FES Cycling session (day 1)

  14. Cerebral perfusion pressure

    Neurological repercussions of a FES Cycling session measured by, If sensors present, Cerebral perfusion pressure.

    Measured: During the FES Cycling session (day 1)

  15. Cerebral tissue oxygen pressure

    Neurological repercussions of a FES Cycling session measured by, If sensors present, Cerebral tissue oxygen pressure.

    Measured: During the FES Cycling session (day 1)

  16. FES cycling installation

    FES Cycling technical feasibility measured by installation and uninstallation times Cycloergometer,

    Measured: After the FES Cycling session (day 1)

  17. FES Cycling technical feasibility

    FES Cycling technical feasibility measured by number of persons needed.

    Measured: After the FES Cycling session (day 1)

  18. Duration of FES Cycling session

    FES Cycling technical feasibility measured by total duration of FES Cycling session.

    Measured: After the FES Cycling session (day 1)

  19. Failure FES Cycling session

    FES Cycling technical feasibility measured by number of procedural failures.

    Measured: After the FES Cycling session (day 1)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 May 2018
  2. Study start24 Jul 2018
  3. Primary completion18 Jun 2019
  4. Study completion18 Jun 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03526211
Sponsor's protocol ID
18CH005
Other IDs
2018-A00541-54
Acronym
FES Cycling
Status last verified
Jun 2019
First submitted
28 Mar 2018
Last updated
15 Jul 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing FES cycling in people with Muscle Weakness, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tolerance (time frame: During the FES Cycling session (day 1)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03526211.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2019.

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