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Mobilization With Neuromuscular Electrical Stimulation in Critical Care Patients

Primary Purpose

Muscular Atrophy

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
NEUROMUSCULAR ELECTRICAL STIMULATION
Conventional physiotherapy
Sponsored by
Hospital de Clinicas de Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Muscular Atrophy focused on measuring electrical stimulation, intensive care unit, muscular atrophy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Centro de Terapia Intensiva do Hospital de ClinicasRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

neuromuscular electrical stimulation

Conventional physiotherapy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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.
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

Full Information

First Posted
October 17, 2014
Last Updated
December 21, 2015
Sponsor
Hospital de Clinicas de Porto Alegre
Collaborators
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Conselho Nacional de Desenvolvimento Científico e Tecnológico
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1. Study Identification

Unique Protocol Identification Number
NCT02298114
Brief Title
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

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Unknown status
Study Start Date
August 2013 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital de Clinicas de Porto Alegre
Collaborators
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Conselho Nacional de Desenvolvimento Científico e Tecnológico

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscular Atrophy
Keywords
electrical stimulation, intensive care unit, muscular atrophy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
neuromuscular electrical stimulation
Arm Type
Experimental
Arm Description
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.
Arm Title
Conventional physiotherapy
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
NEUROMUSCULAR ELECTRICAL STIMULATION
Intervention Description
Neuromuscular electrical stimulation will be applied Functional Electrical Stimulation (FES) machine.
Intervention Type
Other
Intervention Name(s)
Conventional physiotherapy
Intervention Description
The control group will receive conventional physiotherapy associated the placebo electrical stimulation
Primary Outcome Measure Information:
Title
Change in muscle thickness of pectoral and rectus abdominis muscles
Description
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
Time Frame
baseline and after seven days of protocol or 24 hours after extubation
Secondary Outcome Measure Information:
Title
Change Thickness of Diaphragm
Description
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
Time Frame
baseline and after seven days of protocol or 24 hours after extubation .
Title
blood lactate levels
Description
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.
Time Frame
first day of protocol
Title
Change Excursion of the Diaphragm
Description
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
Time Frame
baseline and after seven days of protocol or 24 hours after extubation .
Other Pre-specified Outcome Measures:
Title
length of time on mechanical ventilation
Time Frame
baseline and after seven days of protocol or 24 hours after extubation or deth.
Title
extubation success
Time Frame
baseline and after seven days of protocol or 48 hours after extubation
Title
length of stay in the intensive care unit
Time Frame
patients will be followed for the duration of intensive care unit stay, an expected average of two weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 - 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ana Maria Dall' Acqua
Phone
51-81045216
Email
aninhadallacqua@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Amanda Sachetti
Phone
54-91543394
Email
amandasachetti@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexandre Simões Dias
Organizational Affiliation
Hospital de Clínicas de Porto Alegre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro de Terapia Intensiva do Hospital de Clinicas
City
Porto Alegre
State/Province
Rio Grande do Sul
ZIP/Postal Code
90035-903
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ana Maria Dall Acqua
Phone
55 51 81045216
Email
aninhadallacqua@hotmail.com
First Name & Middle Initial & Last Name & Degree
Amanda Sachetti
Phone
55 54 91543394
Email
amandasachetti@gmail.com
First Name & Middle Initial & Last Name & Degree
Alexandre Simões Dias

12. IPD Sharing Statement

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Mobilization With Neuromuscular Electrical Stimulation in Critical Care Patients

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