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Neuromuscular Electrical Stimulation in the Critically Ill

Primary Purpose

Polyneuropathy

Status
Withdrawn
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Gymna Belgium, DUO 400 (Neuromuscular electrical stimulation)
Sponsored by
Brugmann University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Polyneuropathy focused on measuring critical illness polyneuropathy, critical illness myopathy, neuromuscular electrical stimulation, intensive care unit acquired weakness, prevention of critical illness polyneuropathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • CHU Brugmann

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Stimulated

Control

Arm 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.

Outcomes

Primary Outcome Measures

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).
Length of stay in the intensive care unit
Measured in days
Type of hospital discharge
Back to home or to a specialized long term care structure

Secondary Outcome Measures

cross-sectional area of the rectus femoris
The quadriceps muscle mass will be assessed using an ultrasound system (PHILIPS, VIVIDS5).
cross-sectional area of the rectus femoris
The quadriceps muscle mass will be assessed using an ultrasound system (PHILIPS, VIVIDS5).
cross-sectional area of the rectus femoris
The quadriceps muscle mass will be assessed using an ultrasound system (PHILIPS, VIVIDS5).
cross-sectional area of the rectus femoris
The quadriceps muscle mass will be assessed using an ultrasound system (PHILIPS, VIVIDS5).
cross-sectional area of the rectus femoris
The quadriceps muscle mass will be assessed using an ultrasound system (PHILIPS, VIVIDS5).
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.
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.
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.
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
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
August 14, 2015
Last Updated
May 30, 2018
Sponsor
Brugmann University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02566941
Brief Title
Neuromuscular Electrical Stimulation in the Critically Ill
Official Title
Neuromuscular Electrical Stimulation in the Critically Ill
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Lack of human ressources
Study Start Date
October 1, 2015 (Actual)
Primary Completion Date
May 30, 2018 (Actual)
Study Completion Date
May 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brugmann University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polyneuropathy
Keywords
critical illness polyneuropathy, critical illness myopathy, neuromuscular electrical stimulation, intensive care unit acquired weakness, prevention of critical illness polyneuropathy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stimulated
Arm Type
Experimental
Arm 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.
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
Gymna Belgium, DUO 400 (Neuromuscular electrical stimulation)
Primary Outcome Measure Information:
Title
Duration of respiratory support
Description
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).
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.
Title
Length of stay in the intensive care unit
Description
Measured in days
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.
Title
Type of hospital discharge
Description
Back to home or to a specialized long term care structure
Time Frame
At hospital discharge, within a maximum of two years (approximate study length).
Secondary Outcome Measure Information:
Title
cross-sectional area of the rectus femoris
Description
The quadriceps muscle mass will be assessed using an ultrasound system (PHILIPS, VIVIDS5).
Time Frame
First day in ICU
Title
cross-sectional area of the rectus femoris
Description
The quadriceps muscle mass will be assessed using an ultrasound system (PHILIPS, VIVIDS5).
Time Frame
Third day in ICU
Title
cross-sectional area of the rectus femoris
Description
The quadriceps muscle mass will be assessed using an ultrasound system (PHILIPS, VIVIDS5).
Time Frame
Fifth day in ICU
Title
cross-sectional area of the rectus femoris
Description
The quadriceps muscle mass will be assessed using an ultrasound system (PHILIPS, VIVIDS5).
Time Frame
Seventh day in ICU
Title
cross-sectional area of the rectus femoris
Description
The quadriceps muscle mass will be assessed using an ultrasound system (PHILIPS, VIVIDS5).
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.
Title
Force index - Grip test
Description
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.
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.
Title
Force index - Grip test
Description
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.
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.
Title
Force index - Bike
Description
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.
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.
Title
Force index - Bike
Description
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
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.
Title
Electromyogram
Description
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.
Time Frame
First day of ICU admission
Title
Electromyogram
Description
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.
Time Frame
Third day of ICU admission
Title
Electromyogram
Description
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.
Time Frame
Fifth day of ICU admission
Title
Electromyogram
Description
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.
Time Frame
Seventh day of ICU admission
Title
Electromyogram
Description
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.
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.
Title
Physical Function ICU Test score (PFIT-s)
Description
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.
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.
Title
Physical Function ICU Test score (PFIT-s)
Description
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.
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.
Title
Six minutes Walking Test
Description
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.
Time Frame
the day the patient is discharged from the hospital, within a maximum of 2 years (approximate total study length)
Title
Six minutes Walking Test
Description
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.
Time Frame
one year after the day of admission to the intensive care unit
Title
MOS SF-36
Description
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.
Time Frame
the day the patient is discharged from the hospital, within a maximum of two years (approximated study lenght)
Title
MOS SF-36
Description
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.
Time Frame
one year after the day of admission to the intensive care unit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacques Devriendt, MD
Organizational Affiliation
CHU Brugmann
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Brugmann
City
Brussels
ZIP/Postal Code
1020
Country
Belgium

12. IPD Sharing Statement

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Neuromuscular Electrical Stimulation in the Critically Ill

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