Mobilization With Neuromuscular Electrical Stimulation in Critical Care Patients
NCT ID: NCT02298114
Last Updated: 2015-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
24 participants
INTERVENTIONAL
2013-08-31
2015-12-31
Brief Summary
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Detailed Description
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Objective: To evaluate the effects of early mobilization with neuromuscular electrical stimulation in critical care patients on invasive mechanical ventilation.
Methods: Randomized clinical trial to be conducted in the ICU at the hospital de clínicas of Porto Alegre, RS, Brazil, with two groups, one intervention group (conventional physiotherapy and NMES) and one placebo group (conventional physiotherapy and placebo NMES). Patients on mechanical ventilation who meet the inclusion criteria will be recruited and the intervention will be administered using a 4-channel Ibramed® Neurodyn Functional Electrical Stimulation (FES) machine, every day for thirty minutes until extubation or death. Outcomes will be muscle thickness of pectoral and abdominal muscles and diaphragm excursion measured with ultrasound, before intervention, on the seventh day of intervention and soon after extubation. Additionally, blood lactate and heart rate variability will be assessed. Statistical analysis will be conducted using the Statistical Package for the Social Sciences (SPSS) 20.0 and the significance level will be p\<0.05.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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neuromuscular electrical stimulation
Neuromuscular electrical stimulation will be applied Functional Electrical Stimulation (FES) machine. The electrodes will be placed over the motor points of the following muscles: pectoral muscles (fibres of the pectoralis major muscle) and rectus abdominis muscles (bilaterally) The first training session will have a duration of 30 minutes , which will then be extended by 1 minute for every 2 days of administration. The intensity will be increased until muscle contraction is visible or palpable or, intensity will be adjusted according to tolerance associated conventional physiotherapy. Neuromuscular electrical stimulation will be applied held until extubation end conventional respiratory and motor physiotherapy until discharge from the ICU.
NEUROMUSCULAR ELECTRICAL STIMULATION
Neuromuscular electrical stimulation will be applied Functional Electrical Stimulation (FES) machine.
Conventional physiotherapy
Conventional physiotherapy will be administered by professionals from the physiotherapy department twice a day, for 30 minutes. The protocol will include upper and lower extremity functional diagonals from the proprioceptive neuromuscular facilitation method (two series of 10 repetitions for each bilateral diagonal), manual bronchial hygiene exercises, such as thoracic vibrocompression, manoeuvres with a manual resuscitator (bag squeezing) and aspiration of secretions where necessary. Associated will receive placebo electrical stimulation, in this case the procedure is the same, but intensity is set to a sensory level, not high enough to provoke either visible or palpable muscle contractions.
Conventional physiotherapy
The control group will receive conventional physiotherapy associated the placebo electrical stimulation
Interventions
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NEUROMUSCULAR ELECTRICAL STIMULATION
Neuromuscular electrical stimulation will be applied Functional Electrical Stimulation (FES) machine.
Conventional physiotherapy
The control group will receive conventional physiotherapy associated the placebo electrical stimulation
Eligibility Criteria
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Inclusion Criteria
\-
18 Years
ALL
No
Sponsors
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Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
OTHER_GOV
Conselho Nacional de Desenvolvimento Científico e Tecnológico
OTHER_GOV
Hospital de Clinicas de Porto Alegre
OTHER
Responsible Party
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Principal Investigators
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Alexandre Simões Dias
Role: PRINCIPAL_INVESTIGATOR
Hospital de Clínicas de Porto Alegre
Locations
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Centro de Terapia Intensiva do Hospital de Clinicas
Porto Alegre, Rio Grande do Sul, Brazil
Countries
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Central Contacts
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Facility Contacts
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Ana Maria Dall Acqua
Role: primary
Amanda Sachetti
Role: backup
Other Identifiers
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130433
Identifier Type: -
Identifier Source: org_study_id