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Muscle wasting occurred early and rapidly in critically ill patients. Early therapeutic strategies to either maintain muscle structure and function should be encouraged. Neuromuscular electrical stimulation (NMES) is an attractive intervention to maintain muscle mass and strength in critically ill patients during the first week of ICU stay. This study will test the hypothesis that the number of contraction per day evoked by NMES in the first two weeks of illness may influence in muscle wasting, with beneficial effects on the physical and functional status in mechanically ventilated patients.
Patients with prolonged mechanical ventilation require deep sedation and mechanical ventilation, factors predisposing to the development of skeletal muscle wasting and acute muscle atrophy. Strategies to attenuate this process must be used. The neuromuscular electrostimulation (NMES) leads to the application of electrical currents in the skin aiming at muscle contraction, has beneficial effects for the population of critical patients. However, the number of contractions induced by NMES to attenuate the loss of muscle mass in this population is not yet established. This randomized controlled trial with 120 patients that will be randomized to one of the 3 study groups: 100 continuous daily contractions (100Cd), 50 continuous daily contractions (50Cd) and control group. Muscle thickness, NMES-induced strength, and clinical and functional parameters at the time of discharge from the ICU and hospital discharge will be assessed daily. The results of this project will provide an important contribution to the understanding of the mechanisms associated with NMES treatment as a tool to minimize the effects of muscle disuse, as well as providing scientific support for the clinical use of this resource in the treatment in the light of the policies' health system.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control group | No Intervention | Group that will receive a standard care from physiotherapy staff not involved in delivering the intervention whenever feasible. | |
| 50 electrically evoked contractions | Experimental | Group that will receive a standard care from physiotherapy staff plus neuromuscular electrical stimulation with the following parameters: pulsed current; freqeuncy 50Hz; pulse witdh 400 us, current intensity that get level 4/5 of evoked contractions proposed by Segers et al; on/off time and duration of therapy that allow 50 ellectrically evoked contractions with surface electrodes positioned on the quadriceps femoris. |
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| 100 electrically evoked contractions | Experimental | Group that will receive a standard care from physiotherapy staff plus neuromuscular electrical stimulation with the following parameters: pulsed current; freqeuncy 50Hz; pulse witdh 400 us, current intensity that get level 4/5 of evoked contractions proposed by Segers et al; on/off time and duration of therapy that allow 100 ellectrically evoked contractions with surface electrodes positioned on the quadriceps femoris. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| neuromuscular electrical stimulation | Device | application of an electric current through electrodes placed on the skin over the targeted musclesto induce skeletal muscle contractions |
| Measure | Description | Time Frame |
|---|---|---|
| cross sectional area of rectus femoris | change of muscle wasting assessed by ultrassonogropahy | from baseline to 14 days of therapy |
| echointensity of rectus femoris | change of echointensity of rectus femoris assessed by ultrassonography | from baseline to 14 days of therapy |
| muscle strength | change of evoked peak torque of quadriceps femoris assesssed by unvolitional testing | from baseline to 14 days of therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Functional status | Functional status assessed by IMS scale ranged from 0 to 10 | from baseline to 14 days of therapy |
| ICU acquired weakness | percent of patients that have muscle strength assessed by Medical Research Council Sum-Score (MRC-SS) lower than 48 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| VINICIUS ZACARIAS MALDANER D SILVA | Contact | 6135462517 | viniciusmaldaner@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| VINICIUS ZACARIAS MALDANER D SILVA | Secretaria de Saúde do Distrito Federal | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Secretaria de Saúde do Distrito Federal | Recruiting | BrasÃlia | Federal District | 700000 | Brazil |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D009133 | Muscular Atrophy |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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The assessors will be blinded to randomization
|
| from baseline to 14 days of therapy |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |