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| Name | Class |
|---|---|
| Fondation Paul Bennetot | OTHER |
| Assistance Publique - Hôpitaux de Paris | OTHER |
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The purpose of this study is to determine whether early neuromuscular electrical stimulation is effective in the prevention of neuromuscular weakness in critical ill patients.
Randomized, controlled study of early electrical neurostimulation (vs sham) in critically ill patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neuromuscular electrical stimulation | Experimental | NEMS is delivered bilaterally to the quadriceps femoris muscle using a portable battery-powered stimulator (Rehab 400, Cefar Compex, France). The electrodes are placed on the motor points of vastus medialis and vastus lateralis muscles. Electrical stimuli of 45Hz (pulse width: 380 µseconds; 6 seconds on with 1.5 second rise time; and 0.75 seconds fall time.; 5 seconds off). The current is adjusted to ensure maximum tolerable muscle contraction The protocol is applied twice daily for 25 minutes, five days a week. |
|
| Sham Control | Sham Comparator | No electrostimulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neuromuscular electrical stimulation | Device | NEMS is delivered bilaterally to the quadriceps femoris muscle using a portable battery-powered stimulator (Rehab 400, Cefar Compex, France). The electrodes are placed on the motor points of vastus medialis and vastus lateralis muscles. Electrical stimuli of 45Hz (pulse width: 380 µseconds; 6 seconds on with 1.5 second rise time; and 0.75 seconds fall time.; 5 seconds off). The current is adjusted to ensure maximum tolerable muscle contraction The protocol is applied twice daily for 25 minutes, five days a week. |
| Measure | Description | Time Frame |
|---|---|---|
| Medical resuscitation council (MRC) score | up to 25 months. From date of randomization to the date of ICU discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Total duration of mechanical ventilation (days) | up to 25 months. From date of randomization to the date of ICU discharge | |
| Length of ICU stay and hospital stay. | up to 25 months. From date of randomization to the date of ICU discharge or hospital discharge |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christian Lamer, MD | Contact | +33156616188 | christian.lamer@imm.fr | |
| Celine Menez, PT | Contact | +33156616134 | celine.menez@imm.fr |
| Name | Affiliation | Role |
|---|---|---|
| Christian Lamer, MD | Institut Mutualiste Montsouris, Paris, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Insitut Mutualiste Montsouris | Recruiting | Paris | 75014 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20426834 | 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. | |
| 24758618 | Background |
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| ID | Term |
|---|---|
| D011115 | Polyneuropathies |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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| Sham control | Device | No electrostimulation |
|
| Type of hospital discharge | (alive/deceased/rehabilitation/home...) | up to 25 months. From date of randomization to the date of hospital discharge |
| Kress JP, Hall JB. ICU-acquired weakness and recovery from critical illness. N Engl J Med. 2014 Apr 24;370(17):1626-35. doi: 10.1056/NEJMra1209390. No abstract available. |
| 20046132 | Background | Needham DM, Truong AD, Fan E. Technology to enhance physical rehabilitation of critically ill patients. Crit Care Med. 2009 Oct;37(10 Suppl):S436-41. doi: 10.1097/CCM.0b013e3181b6fa29. |
| 22421734 | Background | Kho ME, Truong AD, Brower RG, Palmer JB, Fan E, Zanni JM, Ciesla ND, Feldman DR, Korupolu R, Needham DM. Neuromuscular electrical stimulation for intensive care unit-acquired weakness: protocol and methodological implications for a randomized, sham-controlled, phase II trial. Phys Ther. 2012 Dec;92(12):1564-79. doi: 10.2522/ptj.20110437. Epub 2012 Mar 15. |