Neuromuscular Electrical Stimulation in the Critically Ill

Study Overview
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Brief Summary
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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.

Official Title
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Neuromuscular Electrical Stimulation in the Critically Ill

Conditions
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Polyneuropathy

Intervention / Treatment
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* Device: Gymna Belgium, DUO 400 (Neuromuscular electrical stimulation)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stimulated<br>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. | Device: Gymna Belgium, DUO 400 (Neuromuscular electrical stimulation)<br> <br> |
| No Intervention: Control<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of respiratory support | 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). | 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. | 
| Length of stay in the intensive care unit | Measured in days | 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. | 
| Type of hospital discharge | Back to home or to a specialized long term care structure | At hospital discharge, within a maximum of two years (approximate study length). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cross-sectional area of the rectus femoris | The quadriceps muscle mass will be assessed using an ultrasound system (PHILIPS, VIVIDS5). | First day in ICU | 
| cross-sectional area of the rectus femoris | The quadriceps muscle mass will be assessed using an ultrasound system (PHILIPS, VIVIDS5). | Third day in ICU | 
| cross-sectional area of the rectus femoris | The quadriceps muscle mass will be assessed using an ultrasound system (PHILIPS, VIVIDS5). | Fifth day in ICU | 
| cross-sectional area of the rectus femoris | The quadriceps muscle mass will be assessed using an ultrasound system (PHILIPS, VIVIDS5). | Seventh day in ICU | 
| cross-sectional area of the rectus femoris | The quadriceps muscle mass will be assessed using an ultrasound system (PHILIPS, VIVIDS5). | 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. | 
| Force index - Grip test | 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 conducted as soon as possible aka when the patient has -1 ≤ RASS ≤ 1, is sufficiently collaborating and little sedated. | 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. | 
| Force index - Grip test | 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. | 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. | 
| Force index - Bike | 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 test will be conducted as soon as possible aka when the patient has -1 ≤ RASS ≤ 1, is sufficiently collaborating and little sedated. | 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. | 
| Force index - Bike | 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 | 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. | 
| Electromyogram | 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. | First day of ICU admission | 
| Electromyogram | 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. | Third day of ICU admission | 
| Electromyogram | 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. | Fifth day of ICU admission | 
| Electromyogram | 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. | Seventh day of ICU admission | 
| Electromyogram | 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. | 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. | 
| Physical Function ICU Test score (PFIT-s) | 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. Patients will be tested as soon as possible aka when the patient has: -1 ≤ RASS ≤ 1, is sufficiently collaborating and not heavily sedated. | 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. | 
| Physical Function ICU Test score (PFIT-s) | 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. | 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. | 
| Six minutes Walking Test | 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. | the day the patient is discharged from the hospital, within a maximum of 2 years (approximate total study length) | 
| Six minutes Walking Test | 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. | one year after the day of admission to the intensive care unit | 
| MOS SF-36 | 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. | the day the patient is discharged from the hospital, within a maximum of two years (approximated study lenght) | 
| MOS SF-36 | 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. | one year after the day of admission to the intensive care unit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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critical illness polyneuropathy, critical illness myopathy, neuromuscular electrical stimulation, intensive care unit acquired weakness, prevention of critical illness polyneuropathy