Clinical trial NCT02298114: Mobilization With Neuromuscular Electrical Stimulation in Critical Care Patients
Official title: The Effects of Early Mobilization With Neuromuscular Electrical Stimulation in Critical Care Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Muscular Atrophy
Keywords: electrical stimulation
intensive care unit
muscular atrophy
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
Collaborators: name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2014-11-21
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Neuromuscular electrical stimulation in pectoral muscles (fibres of the pectoralis major muscle bilaterally) and rectus abdominis muscles (bilaterally) preserves / decreases the loss of muscle mass.

Detailed description: Introduction: Neuromuscular electrical stimulation (NMES) has recently began to be used as an early treatment method for Intensive Care Unit (ICU) patients on invasive mechanical ventilation (IMV) to compensate for or reduce muscle mass losses and muscular atrophy.

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.

Eligibility criteria: Inclusion Criteria:

This will be a randomized clinical trial recruiting patients of both sexes aged ≥ 18 years, no more than 15 days after admission to the intensive care unit at the hospital de clínicas de Porto Alegre, after transfer from the emergency department or wards and put on invasive mechanical ventilation for at least 24 hours

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Exclusion Criteria:

* Exclusion criteria will include neuromuscular diseases causing motor deficits, such as strokes, multiple sclerosis, amyotrophic lateral sclerosis, myasthenia gravis and Guillain Barré syndrome. Patients will also be excluded in the event of extubation less than 48 hours after enrolment on the study; complications during the protocol, such as pneumothorax, reintubation or delayed weaning (3 failed spontaneous ventilation tests); body mass index (BMI) \> 35 kg/m2; pacemaker use, history of epilepsy; or if a patient has undergone an operation involving abdominal or pectoral incisions.

Primary outcomes:
measure: Change in muscle thickness of pectoral and rectus abdominis muscles
timeFrame: baseline and after seven days of protocol or 24 hours after extubation
Secondary outcomes:
measure: Change Thickness of Diaphragm
timeFrame: baseline and after seven days of protocol or 24 hours after extubation .
measure: blood lactate levels
timeFrame: first day of protocol
measure: Change Excursion of the Diaphragm
timeFrame: baseline and after seven days of protocol or 24 hours after extubation .
Other outcomes:
measure: length of time on mechanical ventilation
timeFrame: baseline and after seven days of protocol or 24 hours after extubation or deth.
measure: extubation success
timeFrame: baseline and after seven days of protocol or 48 hours after extubation
measure: length of stay in the intensive care unit
timeFrame: patients will be followed for the duration of intensive care unit stay, an expected average of two weeks
Locations:
city: Porto Alegre
country: Brazil
facility: Centro de Terapia Intensiva do Hospital de Clinicas
state: Rio Grande do Sul
Study officials:
affiliation: Hospital de Clínicas de Porto Alegre
name: Alexandre Simões Dias
role: PRINCIPAL_INVESTIGATOR
References: