Neuromuscular Electrical Stimulation in the Critically Ill
- Conditions
- Polyneuropathy
- Interventions
- Device: Gymna Belgium, DUO 400 (Neuromuscular electrical stimulation)
- Registration Number
- NCT02566941
- Lead Sponsor
- Brugmann University Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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.
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Stimulated Gymna Belgium, DUO 400 (Neuromuscular electrical stimulation) 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.
- Primary Outcome Measures
Name Time Method Duration of respiratory support Patients will be followed for the duration of their intensive care unit stay.The average duration of an intensive care unit stay in the CHU Brugamnn Hospital in 2014, all pathologies mixed, is 6 days. The duration of ventilatory support is defined as the time in days, during which the patient requires invasive media type (continuous or not, intubation or tracheotomy and need the help of the respirator) or noninvasive (discontinuous or CPAP NIV (continuous positive airway pressure, noninvasive ventilation)- dependence). This will be assessed during the entire length of stay of the patient inside the intensive care unit (ICU).
Length of stay in the intensive care unit Patients will be followed for the duration of their intensive care unit stay.The average duration of an intensive care unit stay in the CHU Brugamnn Hospital in 2014, all pathologies mixed, is 6 days. Measured in days
Type of hospital discharge At hospital discharge, within a maximum of two years (approximate study length). Back to home or to a specialized long term care structure
- Secondary Outcome Measures
Name Time Method cross-sectional area of the rectus femoris The day the patient is discharged from the intensive care unit. The average duration of an intensive care unit stay in the CHU Brugamnn Hospital in 2014, all pathologies mixed, is 6 days. The quadriceps muscle mass will be assessed using an ultrasound system (PHILIPS, VIVIDS5).
Physical Function ICU Test score (PFIT-s) the day the patient is discharged from the intensive care unit. The average duration of an intensive care unit stay in the CHU Brugamnn Hospital in 2014, all pathologies mixed, is 6 days. This simple functional test was developed to measure the functional abilities of patients severely debilitated that are found in the ICU. It consists in assessing four different levels of physical ability: the bending force of the shoulder and knee extension in sitting position, measured with the Oxford scale; the level of assistance needed to move from a sitting position to a standing position; and the ability to stand and walk on site.
Electromyogram The day the patient is discharged from the intensive care unit. The average duration of an intensive care unit stay in the CHU Brugamnn Hospital in 2014, all pathologies mixed, is 6 days. The Electrical conduction of nerves fibula will be assessed to detect nerve damage. A positive test will involve a complete electrophysiological monitoring by a specialist.
Force index - Grip test The day the patient is discharged from the intensive care unit. The average duration of an intensive care unit stay in the CHU Brugamnn Hospital in 2014, all pathologies mixed, is 6 days. The "Grip Test" involves measuring the grip force developed by the hand of the patient, using a dynamometer (Neugen Medicals MODEL EH 101). This test will be performed on the day the patient is discharged from the intensive care unit.
Six minutes Walking Test one year after the day of admission to the intensive care unit The 6-minute walk test is a validated and commonly used test to assess submaximal functional capacity; the test is conducted according to the guidelines of the American Thoracic Society.
MOS SF-36 one year after the day of admission to the intensive care unit The MOS SF-36 questionnaire will be proposed to patients on the day of hospital discharge and one year after the day of admission to the ICU, to assess their quality of life.
Force index - Bike The day the patient is discharged from the intensive care unit. The average duration of an intensive care unit stay in the CHU Brugamnn Hospital in 2014, all pathologies mixed, is 6 days. The bike (Neugen Medicals MODEL EH 101) is a true "bike room" which facilitates active and passive mobilization of bedridden patients and allows, among other things, to measure the force developed by the patients and the ratio between active and passive labor work.This will be measured at patient discharge from ICU
Trial Locations
- Locations (1)
CHU Brugmann
🇧🇪Brussels, Belgium