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| Name | Class |
|---|---|
| Hospital Universitario Pedro Ernesto | OTHER |
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To prevent the development of ICUAW, both early mobilization and neuromuscular electrical stimulation (NMES) have been shown to prevent muscle atrophy in critically ill patients by preserving muscle mass. Furthermore, it is of great value that muscle assessment using kinesiological ultrasound becomes routine to monitor this patient's profile with regard to strength, muscle quality and muscle mass. Our objective is to evaluate the muscular changes promoted by NMES in patients under mechanical ventilation. This is a randomized clinical trial study, which will perform NMES sessions for at least 7 days in mechanically ventilated patients. They will also undergo ultrasound assessments of the quadriceps. Patients will be divided into a control group and an NMES group. In addition, general information recorded in the medical record will be collected, such as basic characteristics, laboratory tests and general assessments.
This is a randomized clinical trial study, which will be carried out at the Hospital Universitário Pedro Ernesto between the months of May 2024 and November 2025, where patients admitted to the General CTI will undergo muscle assessments through ultrasound and a protocol of NMES over a period of 7 days. Participants will be randomized and allocated into 2 groups: Control and NMES. After randomization, general information recorded in the medical record will be collected, such as baseline characteristics, laboratory tests, general assessments, Sequential Organ Failure Assessment Score (SOFA), Chelsea Critical Care Physical Assessment Tool (CPAx) functional scale, edema classification, quality and type of contraction during each NMES session, days on pressure support ventilation (PSV) and pressure or volume assist-controlled ventilation (PCV or VCV), use of neuromuscular blocker, corticosteroids, vasoactive amine and the type and days of diet. Patients will undergo ultrasound evaluation of the pennation angle (AP) of the vastus lateralis, cross-sectional area (CSA) of the rectus femoris, thickness (ESP) of the quadriceps and echogenicity (ECHO) of the rectus femoris, within the first 24h post intubation, at 3 days and 7 days post intubation. Muscle assessment was carried out by professional physiotherapists trained and certified for this purpose. For the NMES group, NMES therapy will be performed for 1 hour, once a day and for 7 days. Using the following parameters: Biphasic and symmetrical rectangular pulse, with a frequency of 50Hz, pulse width of 500μs, ON time of 10 seconds, OFF time of 15 seconds, 3 seconds of rise time and 2 seconds of descent time. The intensity is increased to the point that there is complete muscle contraction, visible or palpable. The maximum intensity will be 120 mA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| neuromuscular electrical stimulation (NMES) | Experimental | For the NMES group, NMES therapy will be performed for 1 hour, once a day and for 10 days. Using the following parameters: Biphasic and symmetrical rectangular pulse, with a frequency of 50Hz, pulse width of 500μs, ON time of 10 seconds, OFF time of 15 seconds, 3 seconds of rise time and 2 seconds of descent time. The intensity is increased to the point that there is complete muscle contraction, visible or palpable. The maximum intensity will be 120 mA. |
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| Placebo | Active Comparator | This group will perform conventional physiotherapy according to institutional protocol. Rehabilitation was oriented towards achieving daily motor milestones (sitting on the edge of the bed, sitting in an armchair, getting up and walking) according to the CPAx scale. The same electrostimulation device will be installed, but it will not be turned on. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| neuromuscular electrical stimulation | Device | Application of neuromuscular electrical stimulation using the NeuroDyn III device (IBRAMED, Amparo - SP) |
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| Measure | Description | Time Frame |
|---|---|---|
| Pennation angle (degrees) | Pennation angle measured by ultrasound | First, fifth and tenth days. |
| Measure | Description | Time Frame |
|---|---|---|
| Cross-sectional area (cm2) | Cross-sectional area (cm2) measured by ultrasound | First, fifth and tenth days. |
| Echogenicity (AU) | Echogenicity (AU) measured by ultrasound |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pedro Ernesto University Hospital | Rio de Janeiro | Rio de Janeiro | 20551-030 | Brazil | ||
| State University of Rio de Janeiro |
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fes/parametros
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olhar em artigos
| First, fifth and tenth days. |
| Thickness (cm) | Thickness (cm) measured by ultrasound | First, fifth and tenth days. |
| Days free from mechanical ventilation | Days free from mechanical ventilation within a 28-day interval. | 28-day interval. |
| Extubation success rate (%) | Extubation success rate (%) | 28-day interval. |
| ICU mortality rate (%). | ICU mortality rate (%). | 28-day interval. |
| Rio de Janeiro |
| Rio de Janeiro |
| 20551-030 |
| Brazil |
| Universidade do Estado do Rio de Janeiro | Rio de Janeiro | Rio de Janeiro | 20950-000 | Brazil |