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

NCT03526211 | Completed

• 2 other identifiers: 18CH0052018-A00541-54
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

Intensive care unit acquired muscle weakness; Cycloergometer; Neuromuscular electrical stimulation; FES Cycling

Outcome Measures

Primary Outcomes (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

  During the FES Cycling session (day 1)

Secondary Outcomes (19)

• Systolic blood pressure

  During the FES Cycling session (day 1)

• Haemodynamic tolerance Heart rate

  During the FES Cycling session (day 1)

• Cardiac output measured

  During the FES Cycling session (day 1)

• Fick equation

  During the FES Cycling session (day 1)

• Arterial lactates

  During the FES Cycling session (day 1)

Study Arms (1)

Experimental

EXPERIMENTAL

Patients with FES Cycling

Device: FES cycling

Interventions

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.

Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead
• Laboratoire de Physique ENS de Lyon: collaborator

Study Sites (1)

Chu Saint-Etienne

Saint-Etienne, 42055, France

Location

MeSH Terms

Conditions

Muscle Weakness

Condition Hierarchy (Ancestors)

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

Study Officials

• Jérôme MOREL, MD

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2018
• First Posted: May 16, 2018
• Study Start: July 24, 2018
• Primary Completion: June 18, 2019
• Study Completion: June 18, 2019
• Last Updated: July 15, 2019

Record last verified: 2019-06

Locations

FR (1)