Neuromuscular Electrical Stimulation in the Critically Ill

Polyneuropathy Clinical Trial

Official title:

Neuromuscular Electrical Stimulation in the Critically Ill

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02566941
• Other study ID #: CHUB-SNM001
• Status: Withdrawn
• Phase: N/A
• Start date: October 1, 2015
• Est. completion date: May 30, 2018

Study information

• Verified date: May 2018
• Source: Brugmann University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 30, 2018
• Est. primary completion date: May 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Polyneuropathies
• Polyneuropathy

Intervention

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

Locations

Country	Name	City	State
Belgium	CHU Brugmann	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Brugmann University Hospital

Country where clinical trial is conducted

Belgium, 

References & Publications (16)

Batt J, dos Santos CC, Cameron JI, Herridge MS. Intensive care unit-acquired weakness: clinical phenotypes and molecular mechanisms. Am J Respir Crit Care Med. 2013 Feb 1;187(3):238-46. doi: 10.1164/rccm.201205-0954SO. Epub 2012 Nov 29. Review. — View Citation

Burke D, Gorman E, Stokes D, Lennon O. An evaluation of neuromuscular electrical stimulation in critical care using the ICF framework: a systematic review and meta-analysis. Clin Respir J. 2016 Jul;10(4):407-20. doi: 10.1111/crj.12234. Epub 2014 Nov 26. Review. — View Citation

Dal-Pizzol F, Ritter C. Functional disability 5 years after ARDS. N Engl J Med. 2011 Jul 21;365(3):274-5; author reply 275-6. doi: 10.1056/NEJMc1105509. — View Citation

Denehy L, de Morton NA, Skinner EH, Edbrooke L, Haines K, Warrillow S, Berney S. A physical function test for use in the intensive care unit: validity, responsiveness, and predictive utility of the physical function ICU test (scored). Phys Ther. 2013 Dec;93(12):1636-45. doi: 10.2522/ptj.20120310. Epub 2013 Jul 25. — View Citation

Dirks ML, Wall BT, Snijders T, Ottenbros CL, Verdijk LB, van Loon LJ. Neuromuscular electrical stimulation prevents muscle disuse atrophy during leg immobilization in humans. Acta Physiol (Oxf). 2014 Mar;210(3):628-41. doi: 10.1111/apha.12200. Epub 2013 Dec 12. — View Citation

Hermans G, De Jonghe B, Bruyninckx F, Van den Berghe G. Interventions for preventing critical illness polyneuropathy and critical illness myopathy. Cochrane Database Syst Rev. 2014 Jan 30;(1):CD006832. doi: 10.1002/14651858.CD006832.pub3. Review. — View Citation

Hirose T, Shiozaki T, Shimizu K, Mouri T, Noguchi K, Ohnishi M, Shimazu T. The effect of electrical muscle stimulation on the prevention of disuse muscle atrophy in patients with consciousness disturbance in the intensive care unit. J Crit Care. 2013 Aug;28(4):536.e1-7. doi: 10.1016/j.jcrc.2013.02.010. Epub 2013 Apr 3. — View Citation

Latronico N, Bertolini G, Guarneri B, Botteri M, Peli E, Andreoletti S, Bera P, Luciani D, Nardella A, Vittorielli E, Simini B, Candiani A. Simplified electrophysiological evaluation of peripheral nerves in critically ill patients: the Italian multi-centre CRIMYNE study. Crit Care. 2007;11(1):R11. — View Citation

Latronico N, Nattino G, Guarneri B, Fagoni N, Amantini A, Bertolini G; GiVITI Study Investigators. Validation of the peroneal nerve test to diagnose critical illness polyneuropathy and myopathy in the intensive care unit: the multicentre Italian CRIMYNE-2 diagnostic accuracy study. Version 3. F1000Res. 2014 Jun 11 [revised 2014 Jan 1];3:127. doi: 10.12688/f1000research.3933.3. eCollection 2014. — View Citation

Levine S, Nguyen T, Taylor N, Friscia ME, Budak MT, Rothenberg P, Zhu J, Sachdeva R, Sonnad S, Kaiser LR, Rubinstein NA, Powers SK, Shrager JB. Rapid disuse atrophy of diaphragm fibers in mechanically ventilated humans. N Engl J Med. 2008 Mar 27;358(13):1327-35. doi: 10.1056/NEJMoa070447. — View Citation

Maddocks M, Gao W, Higginson IJ, Wilcock A. Neuromuscular electrical stimulation for muscle weakness in adults with advanced disease. Cochrane Database Syst Rev. 2013 Jan 31;(1):CD009419. doi: 10.1002/14651858.CD009419.pub2. Review. Update in: Cochrane Database Syst Rev. 2016 Oct 17;10 :CD009419. — View Citation

Parry SM, Denehy L, Beach LJ, Berney S, Williamson HC, Granger CL. Functional outcomes in ICU – what should we be using? – an observational study. Crit Care. 2015 Mar 29;19:127. doi: 10.1186/s13054-015-0829-5. — View Citation

Routsi C, Gerovasili V, Vasileiadis I, Karatzanos E, Pitsolis T, Tripodaki E, Markaki V, Zervakis D, Nanas S. Electrical muscle stimulation prevents critical illness polyneuromyopathy: a randomized parallel intervention trial. Crit Care. 2010;14(2):R74. doi: 10.1186/cc8987. Epub 2010 Apr 28. — View Citation

Segers J, Hermans G, Bruyninckx F, Meyfroidt G, Langer D, Gosselink R. Feasibility of neuromuscular electrical stimulation in critically ill patients. J Crit Care. 2014 Dec;29(6):1082-8. doi: 10.1016/j.jcrc.2014.06.024. Epub 2014 Jun 30. — View Citation

Seymour JM, Ward K, Sidhu PS, Puthucheary Z, Steier J, Jolley CJ, Rafferty G, Polkey MI, Moxham J. Ultrasound measurement of rectus femoris cross-sectional area and the relationship with quadriceps strength in COPD. Thorax. 2009 May;64(5):418-23. doi: 10.1136/thx.2008.103986. Epub 2009 Jan 21. — View Citation

Skinner EH, Berney S, Warrillow S, Denehy L. Development of a physical function outcome measure (PFIT) and a pilot exercise training protocol for use in intensive care. Crit Care Resusc. 2009 Jun;11(2):110-5. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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	cross-sectional area of the rectus femoris	The quadriceps muscle mass will be assessed using an ultrasound system (PHILIPS, VIVIDS5).	First day in ICU
Secondary	cross-sectional area of the rectus femoris	The quadriceps muscle mass will be assessed using an ultrasound system (PHILIPS, VIVIDS5).	Third day in ICU
Secondary	cross-sectional area of the rectus femoris	The quadriceps muscle mass will be assessed using an ultrasound system (PHILIPS, VIVIDS5).	Fifth day in ICU
Secondary	cross-sectional area of the rectus femoris	The quadriceps muscle mass will be assessed using an ultrasound system (PHILIPS, VIVIDS5).	Seventh day in ICU
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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)
Secondary	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
Secondary	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)
Secondary	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