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Neuromuscular Electrical Stimulation in the Critically Ill

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ClinicalTrials.gov Identifier: NCT02566941
Recruitment Status : Withdrawn (Lack of human ressources)
First Posted : October 2, 2015
Last Update Posted : May 31, 2018
Sponsor:
Information provided by (Responsible Party):
Jacques DEVRIENDT, 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.


Condition or disease Intervention/treatment Phase
Polyneuropathy Device: Gymna Belgium, DUO 400 (Neuromuscular electrical stimulation) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: Neuromuscular Electrical Stimulation in the Critically Ill
Actual Study Start Date : October 1, 2015
Actual Primary Completion Date : May 30, 2018
Actual Study Completion Date : May 30, 2018

Arm Intervention/treatment
Experimental: Stimulated
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)
No Intervention: Control



Primary Outcome Measures :
  1. Duration of respiratory support [ Time Frame: 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).

  2. Length of stay in the intensive care unit [ Time Frame: 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

  3. Type of hospital discharge [ Time Frame: 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 :
  1. cross-sectional area of the rectus femoris [ Time Frame: First day in ICU ]
    The quadriceps muscle mass will be assessed using an ultrasound system (PHILIPS, VIVIDS5).

  2. cross-sectional area of the rectus femoris [ Time Frame: Third day in ICU ]
    The quadriceps muscle mass will be assessed using an ultrasound system (PHILIPS, VIVIDS5).

  3. cross-sectional area of the rectus femoris [ Time Frame: Fifth day in ICU ]
    The quadriceps muscle mass will be assessed using an ultrasound system (PHILIPS, VIVIDS5).

  4. cross-sectional area of the rectus femoris [ Time Frame: Seventh day in ICU ]
    The quadriceps muscle mass will be assessed using an ultrasound system (PHILIPS, VIVIDS5).

  5. cross-sectional area of the rectus femoris [ Time Frame: 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).

  6. Force index - Grip test [ Time Frame: 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 "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.

  7. Force index - Grip test [ Time Frame: 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.

  8. Force index - Bike [ Time Frame: 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 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.

  9. Force index - Bike [ Time Frame: 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

  10. Electromyogram [ Time Frame: First day of ICU admission ]
    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.

  11. Electromyogram [ Time Frame: Third day of ICU admission ]
    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.

  12. Electromyogram [ Time Frame: Fifth day of ICU admission ]
    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.

  13. Electromyogram [ Time Frame: Seventh day of ICU admission ]
    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.

  14. Electromyogram [ Time Frame: 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.

  15. Physical Function ICU Test score (PFIT-s) [ Time Frame: 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. ]
    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.

  16. Physical Function ICU Test score (PFIT-s) [ Time Frame: 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.

  17. Six minutes Walking Test [ Time Frame: the day the patient is discharged from the hospital, within a maximum of 2 years (approximate total study length) ]
    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.

  18. Six minutes Walking Test [ Time Frame: 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.

  19. MOS SF-36 [ Time Frame: the day the patient is discharged from the hospital, within a maximum of two years (approximated study lenght) ]
    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.

  20. MOS SF-36 [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02566941


Locations
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Belgium
CHU Brugmann
Brussels, Belgium, 1020
Sponsors and Collaborators
Brugmann University Hospital
Investigators
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Principal Investigator: Jacques Devriendt, MD CHU Brugmann

Publications:

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Responsible Party: Jacques DEVRIENDT, Head of clinic, Brugmann University Hospital
ClinicalTrials.gov Identifier: NCT02566941     History of Changes
Other Study ID Numbers: CHUB-SNM001
First Posted: October 2, 2015    Key Record Dates
Last Update Posted: May 31, 2018
Last Verified: May 2018

Keywords provided by Jacques DEVRIENDT, Brugmann University Hospital:
critical illness polyneuropathy
critical illness myopathy
neuromuscular electrical stimulation
intensive care unit acquired weakness
prevention of critical illness polyneuropathy

Additional relevant MeSH terms:
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Critical Illness
Polyneuropathies
Disease Attributes
Pathologic Processes
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases