Muscle Effects Of Neuromuscular Electrostimulation In Mechanically Ventilated Patients In An Icu

NCT06409611 | Completed

• 1 other identifier: 07071995
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 3

Brief Summary

To prevent the development of ICUAW, both early mobilization and neuromuscular electrical stimulation (NMES) have been shown to prevent muscle atrophy in critically ill patients by preserving muscle mass. Furthermore, it is of great value that muscle assessment using kinesiological ultrasound becomes routine to monitor this patient's profile with regard to strength, muscle quality and muscle mass. Our objective is to evaluate the muscular changes promoted by NMES in patients under mechanical ventilation. This is a randomized clinical trial study, which will perform NMES sessions for at least 7 days in mechanically ventilated patients. They will also undergo ultrasound assessments of the quadriceps. Patients will be divided into a control group and an NMES group. In addition, general information recorded in the medical record will be collected, such as basic characteristics, laboratory tests and general assessments.

Conditions

Intensive Care Unit Acquired Weakness

Keywords

neuromuscular electrical stimulation; Intensive Care Unit Acquired Weakness

Outcome Measures

Primary Outcomes (1)

• Pennation angle (degrees)

  Pennation angle measured by ultrasound

  First, fifth and tenth days.

Secondary Outcomes (6)

• Cross-sectional area (cm2)

  First, fifth and tenth days.

• Echogenicity (AU)

  First, fifth and tenth days.

• Thickness (cm)

  First, fifth and tenth days.

• Days free from mechanical ventilation

  28-day interval.

• Extubation success rate (%)

  28-day interval.

Study Arms (2)

neuromuscular electrical stimulation (NMES)

EXPERIMENTAL

For the NMES group, NMES therapy will be performed for 1 hour, once a day and for 10 days. Using the following parameters: Biphasic and symmetrical rectangular pulse, with a frequency of 50Hz, pulse width of 500μs, ON time of 10 seconds, OFF time of 15 seconds, 3 seconds of rise time and 2 seconds of descent time. The intensity is increased to the point that there is complete muscle contraction, visible or palpable. The maximum intensity will be 120 mA.

Device: neuromuscular electrical stimulation

Placebo

ACTIVE COMPARATOR

This group will perform conventional physiotherapy according to institutional protocol. Rehabilitation was oriented towards achieving daily motor milestones (sitting on the edge of the bed, sitting in an armchair, getting up and walking) according to the CPAx scale. The same electrostimulation device will be installed, but it will not be turned on.

Device: neuromuscular electrical stimulation

Interventions

neuromuscular electrical stimulation DEVICE

Application of neuromuscular electrical stimulation using the NeuroDyn III device (IBRAMED, Amparo - SP)

Placebo; neuromuscular electrical stimulation (NMES)

Eligibility Criteria

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

You may qualify if:

• Age ≥18 years;
• On mechanical ventilation in the first 24 hours;
• Provision of written, informed and/or agreed consent for a family member.

You may not qualify if:

• Trauma to the lower limb;
• History of neurological, neuromuscular or debilitating diseases;
• Spinal cord injury;
• Rhabdomyolysis;
• Vascular insufficiency or amputation of the lower limb;
• Previous immobility;
• Epilepsy;
• Musculoskeletal and skin conditions or situations that may interfere in conduct.

Sponsors & Collaborators

• Universidade Federal do Rio de Janeiro: lead
• Hospital Universitario Pedro Ernesto: collaborator

Study Sites (3)

Pedro Ernesto University Hospital

Rio de Janeiro, Rio de Janeiro, 20551-030, Brazil

Location

State University of Rio de Janeiro

Rio de Janeiro, Rio de Janeiro, 20551-030, Brazil

Location

Universidade do Estado do Rio de Janeiro

Rio de Janeiro, Rio de Janeiro, 20950-000, Brazil

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: olhar em artigos
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor of Pneumology

Model Details: fes/parametros

Study Record Dates

• First Submitted: May 7, 2024
• First Posted: May 10, 2024
• Study Start: May 1, 2024
• Primary Completion: June 30, 2025
• Study Completion: July 30, 2025
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (3)