Neuromuscular Electrical Stimulation in the Critically Ill

CHU Brugmann University Hospital

Status: Withdrawn

Conditions: Polyneuropathy

Treatments: Device: Gymna Belgium, DUO 400 (Neuromuscular electrical stimulation)

Study type: Interventional

Funder types: Other

Identifiers

NCT02566941

CHUB-SNM001

Details and patient eligibility

About

Neuromuscular stimulation (NMES) has been used for several years in the rehabilitation of COPD (chronic obstructive pulmonary disease) patients (among others) to improve their resistance to efforts in everyday life. In patients in intensive care, it seems to improve strength, reduce the loss of muscle mass, prevent the development of CIP / CIM (Critical illness polyneuropathy / critical illness myopathy) and perhaps even reduce ventilation days, with expected effects on the duration of hospitalization and the long-term functional outcome. Although its use could sometimes be limited by the development of peripheral edema and use of vasoconstrictors, the main advantage of this technique is the possibility of being used very early, even in patients that require deep sedation . This is extremely important given that the muscular atrophy process already starts 18h after the onset of invasive ventilation and as signs of impaired nerve transmission are developed in one third of patients at risk within 72 hours.

The purpose of the study is to assess the effects, in the short and medium term, of early neuromuscular stimulation in patients who are at higher risk of developing a critical illness polyneuropathy (CIP) / critical illness myopathy (CIM) spectrum disease.

This is a randomized controlled single-blind study comparing a group of patients submitted to NMES early (up to 5 days after admission) versus a control group unstimulated.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Admission in the ICU of the Brugmann Hospital (Unit 1020) with an intended ICU stay superior to 3 days
• Aged over 18 years
• Respiratory assistance needed (invasive and non-invasive ventilation, CPAP or Optiflow and PaO2(arterial oxygen pressure)/FiO2(fraction of inhaled oxygen)<200mmHg)
• SAPSII (Simplified Acute Physiology Score) between entre 35 et 70.

Exclusion criteria

Definitive exclusion criteria:

• patients bearing a pacemaker or an AICD (automatic implantable cardioverter/defibrillator )
• BMI superior to 35
• serious neuromuscular pathologies or alterations in the inferior members that make both tights stimulation impossible
• pregnant women
• patients admitted from Friday evening to Sunday morning

Temporary exclusion criteria:

• Hemodynamic instability (even with filling up and amines: noradrenaline > 0.5y/kg/min and/or dobutamine >5y/kg/min and/or adrenaline ivc)
• Extreme severity with suspicion of death within the first 24 h
• PIC > 20 cmH2O
• Severe agitation (RASS > +1)
• Curare utilisation within the last 24h

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

Stimulated

Experimental group

Description:

Patients included in the 'stimulated' group will be stimulated at the level of the quadriceps twice a day, bilaterally and simultaneously, five days per week from Monday to Friday (Stimulator: Gymna Belgium, DUO 400). The stimulation protocol (rectified alternating current; frequency, 75 Hz; intensity, 0-80 mA; pulse duration, 350 microseconds) is the one proposed by the manufacturer for atrophy prevention. The intensity of the electrical current will be gradually increased, without exceeding 80mA or the pain threshold of the patient.

Treatment:

Device: Gymna Belgium, DUO 400 (Neuromuscular electrical stimulation)

Control

No Intervention group