Neuromuscular electrical stimulation for intensive care unit-acquired weakness: Protocol and methodological implications for a randomized, sham-controlled, phase II trial

Physical Therapy

Volumn 92, Issue 12, 2012, Pages 1564-1579

  Kho, Michelle E ^a   Truong, Alexander D ^b   Brower, Roy G ^a   Palmer, Jeffrey B ^a   Fan, Eddy ^c   Zanni, Jennifer M ^a   Ciesla, Nancy D ^a   Feldman, Dorianne R ^c   Korupolu, Radha ^d   Needham, Dale M ^a  

^a JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b EMORY UNIVERSITY   (United States)

^c UNIVERSITY OF TORONTO   (Canada)

^d UNIVERSITY OF KENTUCKY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; BED REST; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CRITICAL ILLNESS; DYNAMOMETER; ELECTROSTIMULATION THERAPY; HUMAN; INTENSIVE CARE UNIT; LEG; METHODOLOGY; MUSCLE STRENGTH; MUSCLE WEAKNESS; PATHOPHYSIOLOGY; PHASE 2 CLINICAL TRIAL; PHYSIOLOGY; PILOT STUDY; RANDOMIZED CONTROLLED TRIAL;

BED REST; CRITICAL ILLNESS; ELECTRIC STIMULATION THERAPY; HUMANS; INTENSIVE CARE UNITS; LOWER EXTREMITY; MUSCLE STRENGTH; MUSCLE STRENGTH DYNAMOMETER; MUSCLE WEAKNESS; PILOT PROJECTS; RESEARCH DESIGN;

EID: 84869807865     PISSN: 00319023     EISSN: 15386724     Source Type: Journal    
DOI: 10.2522/ptj.20110437     Document Type: Article

References (75)

1. Adhikari NK, Rubenfeld GD. Worldwide demand for critical care. Curr Opin Crit Care. 2011;17:620-625.
2. Spragg RG, Bernard GR, Checkley W, et al. Beyond mortality: future clinical research in acute lung injury. Am J Respir Crit Care Med. 2010;181:1121-1127.
3. Martin GS, Mannino DM, Eaton S, Moss M. The epidemiology of sepsis in the United States from 1979 through 2000. N Engl J Med. 2003;348:1546-1554.
4. Wunsch H, Linde-Zwirble WT, Angus DC, et al. The epidemiology of mechanical ventilation use in the United States. Crit Care Med. 2010;38:1947-1953.
5. Zilberberg MD, de Wit M, Shorr AF. Accuracy of previous estimates for adult prolonged acute mechanical ventilation volume in 2020: update using 2000-2008 data. Crit Care Med. 2012;40:18-20.
6. Needham DM, Bronskill SE, Calinawan JR, et al. Projected incidence of mechanical ventilation in Ontario to 2026: preparing for the aging baby boomers. Crit Care Med. 2005;33:574-579.
7. Cheung AM, Tansey CM, Tomlinson G, et al. Two-year outcomes, health care use, and costs of survivors of acute respiratory distress syndrome. Am J Respir Crit Care Med. 2006;174:538-544.
8. Unroe M, Kahn JM, Carson SS, et al. Oneyear trajectories of care and resource utilization for recipients of prolonged mechanical ventilation: a cohort study. Ann Intern Med. 2010;153:167-175.
9. Herridge MS, Cheung AM, Tansey CM, et al. One-year outcomes in survivors of the acute respiratory distress syndrome. N Engl J Med. 2003;348:683-693.
10. Herridge MS, Tansey CM, Matte A, et al. Functional disability 5 years after acute respiratory distress syndrome. N Engl J Med. 2011;364:1293-1304.
11. Stevens RD, Marshall SA, Cornblath DR, et al. A framework for diagnosing and classifying intensive care unit-acquired weakness. Crit Care Med. 2009;37(10 suppl): S299-S308.
12. Stevens RD, Dowdy DW, Michaels RK, et al. Neuromuscular dysfunction acquired in critical illness: a systematic review. Intensive Care Med. 2007;33:1876-1891.
13. Ali NA, O'Brien JM Jr, Hoffmann SP, et al. Acquired weakness, handgrip strength, and mortality in critically ill patients. Am J Respir Crit Care Med. 2008;178:261-268.
14. De Jonghe B, Bastuji-Garin S, Durand MC, et al. Respiratory weakness is associated with limb weakness and delayed weaning in critical illness. Crit Care Med. 2007;178: 261-268.
15. De Jonghe B, Bastuji-Garin S, Sharshar T, et al. Does ICU-acquired paresis lengthen weaning from mechanical ventilation? Intensive Care Med. 2004;30:1117-1121.
16. Garnacho-Montero J, Amaya-Villar R, Garcia-Garmendia JL, et al. Effect of critical illness polyneuropathy on the withdrawal from mechanical ventilation and the length of stay in septic patients. Crit Care Med. 2005;33:349-354.
17. Rudis MI, Guslits BJ, Peterson EL, et al. Economic impact of prolonged motor weakness complicating neuromuscular blockade in the intensive care unit. Crit Care Med. 1996;24:1749-1756.
18. Sharshar T, Bastuji-Garin S, Stevens RD, et al. Presence and severity of intensive care unit-acquired paresis at time of awakening are associated with increased intensive care unit and hospital mortality. Crit Care Med. 2009;37:3047-3053.
19. Burtin C, Clerckx B, Robbeets C, et al. Early exercise in critically ill patients enhances short-term functional recovery. Crit Care Med. 2009;37:2499-2505.
20. Schweickert WD, Pohlman MC, Pohlman AS, et al. Early physical and occupational therapy in mechanically ventilated, critically ill patients: a randomised controlled trial. Lancet. 2009;373:1874-1882.
21. Maffiuletti NA. Physiological and methodological considerations for the use of neuromuscular electrical stimulation. Eur J Appl Physiol. 2010;110:223-234.
22. Meesen RL, Dendale P, Cuypers K, et al. Neuromuscular electrical stimulation as a possible means to prevent muscle tissue wasting in artificially ventilated and sedated patients in the intensive care unit: a pilot study. Neuromodulation. 2010;13: 315-321.
23. World Report on Disability 2011. Geneva, Switzerland: World Health Organization; 2011.
24. Needham DM. Mobilizing patients in the intensive care unit: improving neuromuscular weakness and physical function. JAMA. 2008;300:1685-1690.
25. Bolton CF, Young GB. Managing the nervous system effects of sepsis. Chest. 2007; 131:1273-1274.
26. Petty TL. Suspended life or extending death? Chest. 1998;114:360-361.
27. LeBlanc AD, Schneider VS, Evans HJ, et al. Regional changes in muscle mass following 17 weeks of bed rest. J Appl Physiol. 1992;73:2172-2178.
28. Ferrando AA, Stuart CA, Brunder DG, Hillman GR. Magnetic resonance imaging quantitation of changes in muscle volume during 7 days of strict bed rest. Aviat Space Environ Med. 1995;66:976-981.
29. Brower RG. Consequences of bed rest. Crit Care Med. 2009;37(10 suppl):S422-S428.
30. Petersen AM, Pedersen BK. The antiinflammatory effect of exercise. J Appl Physiol. 2005;98:1154-1162.
31. Ferrando AA, Paddon-Jones D, Wolfe RR. Bed rest and myopathies. Curr Opin Clin Nutr Metab Care. 2006;9:410-415.
32. Reid CL, Campbell IT, Little RA. Muscle wasting and energy balance in critical illness. Clin Nutr. 2004;23:273-280.
33. Finn PJ, Plank LD, Clark MA, et al. Progressive cellular dehydration and proteolysis in critically ill patients. Lancet. 1996;347: 654-656.
34. Griffiths RD. Muscle mass, survival, and the elderly ICU patient. Nutrition. 1996; 12:456-458.
35. Ahlbeck K, Fredriksson K, Rooyackers O, et al. Signs of critical illness polyneuropathy and myopathy can be seen early in the ICU course. Acta Anaesthesiol Scand. 2009;53:717-723.
36. Bailey P, Thomsen GE, Spuhler VJ, et al. Early activity is feasible and safe in respiratory failure patients. Crit Care Med. 2007;35:139-145.
37. Morris PE, Goad A, Thompson C, et al. Early intensive care unit mobility therapy in the treatment of acute respiratory failure. Crit Care Med. 2008;36:2238-2243.
38. Needham DM, Korupolu R. Rehabilitation quality improvement in an intensive care unit setting: implementation of a quality improvement model. Top Stroke Rehabil. 2010;17:271-281.
39. Needham DM, Korupolu R, Zanni JM, et al. Early physical medicine and rehabilitation for patients with acute respiratory failure: a quality improvement project. Arch Phys Med Rehabil. 2010;91:536-542.
40. Thomsen GE, Snow GL, Rodriguez L, Hopkins RO. Patients with respiratory failure increase ambulation after transfer to an intensive care unit where early activity is a priority. Crit Care Med. 2008;36:1119-1124.
41. Zanni JM, Korupolu R, Fan E, et al. Rehabilitation therapy and outcomes in acute respiratory failure: an observational pilot project. J Crit Care. 2010;25:254-262.
42. Pohlman MC, Schweickert WD, Pohlman AS, et al. Feasibility of physical and occupational therapy beginning from initiation of mechanical ventilation. Crit Care Med. 2010;38:2089-2094.
43. Bailey PP, Miller RR III, Clemmer TP. Culture of early mobility in mechanically ventilated patients. Crit Care Med. 2009; 37(10 suppl):S429-S435.
44. Hopkins RO, Spuhler VJ. Strategies for promoting early activity in critically ill mechanically ventilated patients. AACN Adv Crit Care. 2009;20:277-289.
45. Hopkins RO, Spuhler VJ, Thomsen GE. Transforming ICU culture to facilitate early mobility. Crit Care Clin. 2007;23:81-96.
46. Garzon-Serrano J, Ryan C, Waak K, et al. Early mobilization in critically ill patients: patients' mobilization level depends on health care provider's profession. PM R. 2011;3:307-313.
47. Truong AD, Fan E, Brower RG, Needham DM. Bench-to-bedside review: mobilizing patients in the intensive care unit-from pathophysiology to clinical trials. Crit Care. 2009;13:216.
48. Gibson JN, Smith K, Rennie MJ. Prevention of disuse muscle atrophy by means of electrical stimulation: maintenance of protein synthesis. Lancet. 1988;2:767-770.
49. Bouletreau P, Patricot MC, Saudin F, et al. Effects of intermittent electrical stimulations on muscle catabolism in intensive care patients. JPEN J Parenter Enteral Nutr. 1987;11:552-555.
50. Gerovasili V, Stefanidis K, Vitzilaios K, et al. Electrical muscle stimulation preserves the muscle mass of critically ill patients: a randomized study. Crit Care. 2009;13:R161.
51. Gerovasili V, Tripodaki E, Karatzanos E, et al. Short-term systemic effect of electrical muscle stimulation in critically ill patients. Chest. 2009;136:1249-1256.
52. Gruther W, Kainberger F, Fialka-Moser V, et al. Effects of neuromuscular electrical stimulation on muscle layer thickness of knee extensor muscles in intensive care unit patients: a pilot study. J Rehabil Med. 2010;42:593-597.
53. Poulsen JB, Moller K, Jensen CV, et al. Effect of transcutaneous electrical muscle stimulation on muscle volume in patients with septic shock. Crit Care Med. 2011; 39:456-461.
54. Rodriguez PO, Setten M, Maskin LP, et al. Muscle weakness in septic patients requiring mechanical ventilation: protective effect of transcutaneous neuromuscular electrical stimulation. J Crit Care. 2011 June 27 [Epub ahead of print].
55. Routsi C, Gerovasili V, Vasileiadis I, et al. Electrical muscle stimulation prevents critical illness polyneuromyopathy: a randomized parallel intervention trial. Crit Care. 2010;14:R74.
56. Zanotti E, Felicetti G, Maini M, Fracchia C. Peripheral muscle strength training in bedbound patients with COPD receiving mechanical ventilation: effect of electrical stimulation. Chest. 2003;124:292-296.
57. Jette AM. Toward a common language for function, disability, and health. Phys Ther. 2006;86:726-734.
58. Brower RG, Fessler HE. Another "negative" trial of surfactant: time to bury this idea? Am J Respir Crit Care Med. 2011; 183:966-968.
59. Arnold DM, Burns KE, Adhikari NK, et al. The design and interpretation of pilot trials in clinical research in critical care. Crit Care Med. 2009;37(1 suppl):S69-S74.
60. Moher D, Hopewell S, Schulz KF, et al. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ. 2010; 340:c869.
61. Ely EW, Shintani A, Truman B, et al. Delirium as a predictor of mortality in mechanically ventilated patients in the intensive care unit. JAMA. 2004;291:1753-1762.
62. Fan E, Shahid S, Kondreddi VP, et al. Informed consent in the critically ill: a two-step approach incorporating delirium screening. Crit Care Med. 2008;36:94-99.
63. Doig GS, Simpson F. Randomization and allocation concealment: a practical guide for researchers. J Crit Care. 2005;20:187-191.
64. Bourjeily-Habr G, Rochester CL, Palermo F, et al. Randomised controlled trial of transcutaneous electrical muscle stimulation of the lower extremities in patients with chronic obstructive pulmonary disease. Thorax. 2002;57:1045-1049.
65. Vivodtzev I, Pepin JL, Vottero G, et al. Improvement in quadriceps strength and dyspnea in daily tasks after 1 month of electrical stimulation in severely deconditioned and malnourished COPD. Chest. 2006;129:1540-1548.
66. Baker LL, McNeal CL, Newsam DR, et al. Neuro Muscular Electrical Stimulation: A Practical Guide. 4th ed. Downey, CA: Los Amigos Research & Education Institute; 2000.
67. Gelinas C, Fortier M, Viens C, et al. Pain assessment and management in critically ill intubated patients: a retrospective study. Am J Crit Care. 2004;13:126-135.
68. Hamill-Ruth RJ, Marohn ML. Evaluation of pain in the critically ill patient. Crit Care Clin. 1999;15:35-54, v-vi.
69. American Spinal Injury Association. International standards for the classification of spinal cord injury: motor exam guide. Available at: http://www.asia-spinalinjury.org/elearning/Motor_Exam_Guide.pdf. Published June 2008. Accessed March 13, 2012.
70. Neurological assessment: the motor examination. In: Reference Manual of the International Standards for Neurological Classification of Spinal Cord Injury. Chicago, IL: American Spinal Injury Association; 2003.
71. Tzanis G, Vasileiadis I, Zervakis D, et al. Maximum inspiratory pressure, a surrogate parameter for the assessment of ICUacquired weakness. BMC Anesthesiol. 2011;11:14.
72. Neder JA, Sword D, Ward SA, et al. Home based neuromuscular electrical stimulation as a new rehabilitative strategy for severely disabled patients with chronic obstructive pulmonary disease (COPD). Thorax. 2002;57:333-337.
73. Quittan M, Wiesinger GF, Sturm B, et al. Improvement of thigh muscles by neuromuscular electrical stimulation in patients with refractory heart failure: a single-blind, randomized, controlled trial. Am J Phys Med Rehabil. 2001;80:206-214.
74. Guyatt GH, Rennie D, Meade MO, Cook DJ, eds. Users' Guides to the Medical Literature: A Manual for Evidence-Based Clinical Practice. 2nd ed. Chicago, IL: AMA Press; 2008.
75. Nattrass CL, Nitschke JE, Disler PB, et al. Lumbar spine range of motion as a measure of physical and functional impairment: an investigation of validity. Clin Rehabil. 1999;13:211-218.