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.

Study Overview

• Status: Completed
• Conditions: Intensive Care Unit Acquired Weakness
• Intervention / Treatment: Device: neuromuscular electrical stimulation

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Rio de Janeiro
    • Rio de Janeiro, Rio de Janeiro, Brazil, 20551-030
      • Pedro Ernesto University Hospital
    • Rio de Janeiro, Rio de Janeiro, Brazil, 20551-030
      • State University of Rio de Janeiro
    • Rio de Janeiro, Rio de Janeiro, Brazil, 20950-000
      • Universidade do Estado do Rio de Janeiro

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Trauma to the lower limb;
2. History of neurological, neuromuscular or debilitating diseases;
3. Spinal cord injury;
4. Rhabdomyolysis;
5. Vascular insufficiency or amputation of the lower limb;
6. Previous immobility;
7. Epilepsy;
8. Musculoskeletal and skin conditions or situations that may interfere in conduct.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: neuromuscular electrical stimulation (NMES); 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; Application of neuromuscular electrical stimulation using the NeuroDyn III device (IBRAMED, Amparo - SP)
Active Comparator: Placebo; 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; Application of neuromuscular electrical stimulation using the NeuroDyn III device (IBRAMED, Amparo - SP)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pennation angle (degrees)	Pennation angle measured by ultrasound	First, fifth and tenth days.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cross-sectional area (cm2)	Cross-sectional area (cm2) measured by ultrasound	First, fifth and tenth days.
Echogenicity (AU)	Echogenicity (AU) measured by ultrasound	First, fifth and tenth days.
Thickness (cm)	Thickness (cm) measured by ultrasound	First, fifth and tenth days.
Days free from mechanical ventilation	Days free from mechanical ventilation within a 28-day interval.	28-day interval.
Extubation success rate (%)	Extubation success rate (%)	28-day interval.
ICU mortality rate (%).	ICU mortality rate (%).	28-day interval.

Collaborators and Investigators

• Sponsor: Universidade Federal do Rio de Janeiro
• Collaborators: Hospital Universitario Pedro Ernesto

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2024
• Primary Completion (Actual): June 30, 2025
• Study Completion (Actual): July 30, 2025

Study Registration Dates

• First Submitted: May 7, 2024
• First Submitted That Met QC Criteria: May 7, 2024
• First Posted (Actual): May 10, 2024

Study Record Updates

• Last Update Posted (Actual): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 17, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: neuromuscular electrical stimulation; Intensive Care Unit Acquired Weakness
• Additional Relevant MeSH Terms: Asthenia
• Other Study ID Numbers: 07071995

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No