Mobilization With Neuromuscular Electrical Stimulation in Critical Care Patients

The Effects of Early Mobilization With Neuromuscular Electrical Stimulation in Critical Care Patients

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.

Study Overview

• Status: Unknown
• Conditions: Muscular Atrophy
• Intervention / Treatment: Device: NEUROMUSCULAR ELECTRICAL STIMULATION; Other: Conventional physiotherapy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Rio Grande do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
      • Recruiting
      • Centro de Terapia Intensiva do Hospital de Clinicas
      • Contact: Ana Maria Dall Acqua; Phone Number: 55 51 81045216; Email: aninhadallacqua@hotmail.com
      • Contact: Amanda Sachetti; Phone Number: 55 54 91543394; Email: amandasachetti@gmail.com
      • Principal Investigator: Alexandre Simões Dias

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Device: NEUROMUSCULAR ELECTRICAL STIMULATION; Neuromuscular electrical stimulation will be applied Functional Electrical Stimulation (FES) machine.
SHAM_COMPARATOR: 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.	Other: Conventional physiotherapy; The control group will receive conventional physiotherapy associated the placebo electrical stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in muscle thickness of pectoral and rectus abdominis muscles	The initial examination by ultrasound will be performed on the first day of the individual in the protocol and the final examination on the seventh day of the protocol	baseline and after seven days of protocol or 24 hours after extubation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change Thickness of Diaphragm	The initial examination by ultrasound will be performed on the first day of the individual in the protocol and the final examination on the seventh day of the protocol	baseline and after seven days of protocol or 24 hours after extubation .
blood lactate levels	realized only on the first day of the protocol, three measures were evaluated: before starting the session of electrostimulation, in half the time of the session and after logout.	first day of protocol
Change Excursion of the Diaphragm	The initial examination by ultrasound will be performed on the first day of the individual in the protocol and the final examination on the seventh day of the protocol	baseline and after seven days of protocol or 24 hours after extubation .

Other Outcome Measures

Outcome Measure	Time Frame
length of time on mechanical ventilation	baseline and after seven days of protocol or 24 hours after extubation or deth.
extubation success	baseline and after seven days of protocol or 48 hours after extubation
length of stay in the intensive care unit	patients will be followed for the duration of intensive care unit stay, an expected average of two weeks

Collaborators and Investigators

• Sponsor: Hospital de Clinicas de Porto Alegre
• Collaborators: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.; Conselho Nacional de Desenvolvimento Científico e Tecnológico
• Investigators: Principal Investigator: Alexandre Simões Dias, Hospital de Clinicas de Porto Alegre

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (ANTICIPATED): December 1, 2015
• Study Completion (ANTICIPATED): December 1, 2015

Study Registration Dates

• First Submitted: October 17, 2014
• First Submitted That Met QC Criteria: November 19, 2014
• First Posted (ESTIMATE): November 21, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): December 22, 2015
• Last Update Submitted That Met QC Criteria: December 21, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: intensive care unit; electrical stimulation; muscular atrophy
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy
• Other Study ID Numbers: 130433