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

NCT ID: NCT03526211

Last Updated: 2019-07-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-24
• Study Completion Date: 2019-06-18

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.

Conditions

Muscle Weakness

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Experimental

Patients with FES Cycling

Group Type: EXPERIMENTAL

FES cycling

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Laboratoire de Physique ENS de Lyon

UNKNOWN

Sponsor Role: collaborator

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jérôme MOREL, MD

Role: PRINCIPAL_INVESTIGATOR

CHU SAINT-ETIENNE

Locations

Chu Saint-Etienne

Saint-Etienne, , France

Countries

France

Other Identifiers

2018-A00541-54

Identifier Type: OTHER

Identifier Source: secondary_id

18CH005

Identifier Type: -

Identifier Source: org_study_id