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Completed

NCT Number: NCT06409611

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pedro Ernesto University Hospital, Rio de Janeiro, Brazil

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About this study

This is a randomized clinical trial study, which will be carried out at the Hospital Universitário Pedro Ernesto between the months of May 2024 and November 2025, where patients admitted to the General CTI will undergo muscle assessments through ultrasound and a protocol of NMES over a period of 7 days. Participants will be randomized and allocated into 2 groups: Control and NMES. After randomization, general information recorded in the medical record will be collected, such as baseline characteristics, laboratory tests, general assessments, Sequential Organ Failure Assessment Score (SOFA), Chelsea Critical Care Physical Assessment Tool (CPAx) functional scale, edema classification, quality and type of contraction during each NMES session, days on pressure support ventilation (PSV) and pressure or volume assist-controlled ventilation (PCV or VCV), use of neuromuscular blocker, corticosteroids, vasoactive amine and the type and days of diet. Patients will undergo ultrasound evaluation of the pennation angle (AP) of the vastus lateralis, cross-sectional area (CSA) of the rectus femoris, thickness (ESP) of the quadriceps and echogenicity (ECHO) of the rectus femoris, within the first 24h post intubation, at 3 days and 7 days post intubation. Muscle assessment was carried out by professional physiotherapists trained and certified for this purpose. For the NMES group, NMES therapy will be performed for 1 hour, once a day and for 7 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

Neuromuscular Electrical Stimulation

Device

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

Primary outcomes

  1. Pennation angle (degrees)

    Time frame: First, fifth and tenth days.

    Pennation angle measured by ultrasound

Secondary outcomes

  1. Cross-sectional area (cm2)

    Time frame: First, fifth and tenth days.

    Cross-sectional area (cm2) measured by ultrasound

  2. Echogenicity (AU)

    Time frame: First, fifth and tenth days.

    Echogenicity (AU) measured by ultrasound

  3. Thickness (cm)

    Time frame: First, fifth and tenth days.

    Thickness (cm) measured by ultrasound

  4. Days free from mechanical ventilation

    Time frame: 28-day interval.

    Days free from mechanical ventilation within a 28-day interval.

  5. Extubation success rate (%)

    Time frame: 28-day interval.

    Extubation success rate (%)

  6. ICU mortality rate (%).

    Time frame: 28-day interval.

    ICU mortality rate (%).

Sponsors and collaborators

Lead sponsor

Universidade Federal do Rio de Janeiro

Other

Collaborators

  • Hospital Universitario Pedro Ernesto

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 10, 2024
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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