Neuromuscular Electrical Stimulation in the Critically Ill

NCT02566941 | Withdrawn

• 1 other identifier: CHUB-SNM001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Polyneuropathy

Keywords

critical illness polyneuropathy; critical illness myopathy; neuromuscular electrical stimulation; intensive care unit acquired weakness; prevention of critical illness polyneuropathy

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (20)

• cross-sectional area of the rectus femoris

  First day in ICU

• cross-sectional area of the rectus femoris

  Third day in ICU

• cross-sectional area of the rectus femoris

  Fifth day in ICU

• cross-sectional area of the rectus femoris

  Seventh day in ICU

• 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.

Study Arms (2)

Stimulated

EXPERIMENTAL

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)

Control

NO INTERVENTION

Interventions

Gymna Belgium, DUO 400 (Neuromuscular electrical stimulation) DEVICE

Stimulated

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Brugmann University Hospital: lead

Study Sites (1)

CHU Brugmann

Brussels, 1020, Belgium

Location

Related Publications (16)

• 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. No abstract available.

  PMID: 21774725 BACKGROUND

• 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.

  PMID: 23204256 BACKGROUND

• 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;2014(1):CD006832. doi: 10.1002/14651858.CD006832.pub3.

  PMID: 24477672 BACKGROUND

• 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.

  PMID: 23440837 BACKGROUND

• 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.

  PMID: 24251881 BACKGROUND

• 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.

  PMID: 20426834 BACKGROUND

• 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.

  PMID: 25353646 BACKGROUND

• 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.

  PMID: 23561945 BACKGROUND

• 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.

  PMID: 25108833 BACKGROUND

• 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.

  PMID: 18367735 BACKGROUND

• 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. doi: 10.1186/cc5671.

  PMID: 17254336 BACKGROUND

• 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.

  PMID: 19158125 BACKGROUND

• 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. F1000Res. 2014 Jun 11;3:127. doi: 10.12688/f1000research.3933.3. eCollection 2014.

  PMID: 25309729 BACKGROUND

• 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.

  PMID: 19485874 BACKGROUND

• 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.

  PMID: 23886842 BACKGROUND

• 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(1):127. doi: 10.1186/s13054-015-0829-5.

  PMID: 25888469 BACKGROUND

MeSH Terms

Conditions

Polyneuropathies

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Jacques Devriendt, MD

  CHU Brugmann

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of clinic

Study Record Dates

• First Submitted: August 14, 2015
• First Posted: October 2, 2015
• Study Start: October 1, 2015
• Primary Completion: May 30, 2018
• Study Completion: May 30, 2018
• Last Updated: May 31, 2018

Record last verified: 2018-05

Locations

BE (1)