Mobilization With Neuromuscular Electrical Stimulation in Critical Care Patients

NCT02298114 | Unknown

• 1 other identifier: 130433
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Muscular Atrophy

Keywords

electrical stimulation; intensive care unit; muscular atrophy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change Thickness of Diaphragm

  baseline and after seven days of protocol or 24 hours after extubation .

• blood lactate levels

  first day of protocol

• Change Excursion of the Diaphragm

  baseline and after seven days of protocol or 24 hours after extubation .

Other Outcomes (3)

• 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

Study Arms (2)

neuromuscular electrical stimulation

EXPERIMENTAL

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

Conventional physiotherapy

SHAM COMPARATOR

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

Interventions

NEUROMUSCULAR ELECTRICAL STIMULATION DEVICE

Neuromuscular electrical stimulation will be applied Functional Electrical Stimulation (FES) machine.

neuromuscular electrical stimulation

Conventional physiotherapy OTHER

The control group will receive conventional physiotherapy associated the placebo electrical stimulation

Conventional physiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead
• Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.: collaborator
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator

Study Sites (1)

Centro de Terapia Intensiva do Hospital de Clinicas

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

RECRUITING

MeSH Terms

Conditions

Muscular Atrophy

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Alexandre Simões Dias

  Hospital de Clínicas de Porto Alegre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ana Maria Dall' Acqua

CONTACT

51-81045216; aninhadallacqua@hotmail.com

Amanda Sachetti

CONTACT

54-91543394; amandasachetti@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2014
• First Posted: November 21, 2014
• Study Start: August 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 22, 2015

Record last verified: 2015-12

Locations

BR (1)