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

C

Centre Hospitalier Universitaire de Saint Etienne

Status

Completed

Conditions

Muscle Weakness

Treatments

Device: FES cycling

Study type

Interventional

Funder types

Other

Identifiers

NCT03526211
18CH005
2018-A00541-54 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

20 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

Experimental
Experimental group
Description:
Patients with FES Cycling
Treatment:
Device: FES cycling

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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