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This study had to be suspended due to COVID-19 Pandemic.
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The study will investigate the effects of neuromuscular electrical stimulation (NMES) in critically ill patients. The objective of this study will be investigate the effects of neuromuscular electrical stimulation (NMES) in critically ill patients.
The study will investigate the effects of neuromuscular electrical stimulation (NMES) in critically ill patients. It will be a randomised crossover clinical trial. Thirty-one patients will enrolled. Patients will be selected, randomly, to the intervention Protocol (decubitus position with the limbs raised and NMES) and control (decubitus position with the limbs raised without NMES).The patients will be allocated in Group 1 (intervention and control) or group 2 (control and intervention) with a wash-out period of 4 to 6 hours between them.
The main outcome will be metabolic data. Linear mixed model will be used for analysis of dependent variables and estimated values of the mean of the differences of each effect.
The results of this study will allow better understanding of the metabolic effects of NMES in patients critically ill.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: group 1 | Experimental | Neuromuscular Electrical Stimulation (NMES) and after decubitus position with the limbs raised without NMES. |
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| group 2 | Sham Comparator | Decubitus Position with the limbs raised withou tNeuromuscular Electrical Stimulation and after Neuromuscular Electrical Stimulation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neuromuscular Electrical Stimulation | Device | This device produces a muscle contraction in response to a externally generated low-voltage electric impulse, which is conducted through electrodes placed on the skin over the muscle group to be stimulated. |
| Measure | Description | Time Frame |
|---|---|---|
| Change of Oxygen consumption (VO2),from baseline and interventions. | Change of Oxygen consumption (VO2) will be evaluated by calorimetry | VO2 will be taken during the each intervention, it will be taken only the first day |
| Measure | Description | Time Frame |
|---|---|---|
| Change of Carbon dioxide production (VCO2) from baseline and interventions. | Change of Carbon dioxide production (VCO2) will be evaluated by calorimetry | VCO2 will be taken during the each intervention, it will be taken only the first day |
| Measure | Description | Time Frame |
|---|---|---|
| Change of Resting energy expenditure (REE) from baseline and interventions. | Change of Resting energy expenditure (REE) will be evaluated by calorimetry | REE will be taken during the each intervention, it will be taken only the first day |
Inclusion Criteria:
Exclusion Criteria:
In general:
Contraindications for the use of NMES:
Contraindications to begin or continue NMES procedure:
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| Name | Affiliation | Role |
|---|---|---|
| Ada C Gastaldi, PhD | Ribeirao Preto Medicine School-University of São Paulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinics Hospital | Ribeirão Preto | São Paulo | 14049-900 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35176099 | Derived | Lago AF, Basile-Filho A, de Oliveira AS, de Souza HCD, Dos Santos DO, Gastaldi AC. Effects of physical therapy with neuromuscular electrical stimulation in acute and late septic shock patients: A randomised crossover clinical trial. PLoS One. 2022 Feb 17;17(2):e0264068. doi: 10.1371/journal.pone.0264068. eCollection 2022. |
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All of the individual participant data collected during the trial, after deidentification, will be available.
The data will be available immediately following publication and for five years.
The data will be available from the principal investigator upon reasonable request.
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