Mobilization With Neuromuscular Electrical Stimulation in Critical Care Patients

Muscular Atrophy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02298114
• Other study ID #: 130433
• Status: Recruiting
• Phase: N/A
• First received: October 17, 2014
• Last updated: December 21, 2015
• Start date: August 2013
• Est. completion date: December 2015

Study information

• Verified date: December 2015
• Source: Hospital de Clinicas de Porto Alegre
• Contact: Ana Maria Dall' Acqua
• Phone: 51-81045216
• Email: aninhadallacqua[@]hotmail.com
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Muscular Atrophy

Intervention

Device:
• NEUROMUSCULAR ELECTRICAL STIMULATION
Neuromuscular electrical stimulation will be applied Functional Electrical Stimulation (FES) machine.

Other:
• Conventional physiotherapy
The control group will receive conventional physiotherapy associated the placebo electrical stimulation

Locations

Country	Name	City	State
Brazil	Centro de Terapia Intensiva do Hospital de Clinicas	Porto Alegre	Rio Grande do Sul

Sponsors (3)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre	Conselho Nacional de Desenvolvimento Científico e Tecnológico, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	length of time on mechanical ventilation		baseline and after seven days of protocol or 24 hours after extubation or deth.	No
Other	extubation success		baseline and after seven days of protocol or 48 hours after extubation	No
Other	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	No
Primary	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	No
Secondary	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 .	No
Secondary	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	No
Secondary	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 .	No