MUSCLE EFFECTS OF NEUROMUSCULAR ELECTROSTIMULATION IN MECHANICALLY VENTILATED PATIENTS IN AN ICU

Intensive Care Unit Acquired Weakness Clinical Trial

Official title:

MUSCLE EFFECTS OF NEUROMUSCULAR ELECTROSTIMULATION IN MECHANICALLY VENTILATED PATIENTS IN AN ICU

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06409611
• Other study ID #: 07071995
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: April 1, 2026

Study information

• Verified date: April 2024
• Source: Universidade Federal do Rio de Janeiro
• Contact: Larissa A Lago
• Phone: 21983255721
• Email: larissaalago[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 10 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.

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 10 days. Participants will be randomized and allocated into 2 groups: placebo 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 5 days and 10 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 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 22
• Est. completion date: April 1, 2026
• Est. primary completion date: November 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Asthenia
• Intensive Care Unit Acquired Weakness

Intervention

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

Locations

Country	Name	City	State
Brazil	Pedro Ernesto University Hospital	Rio De Janeiro

Sponsors (2)

Lead Sponsor	Collaborator
Universidade Federal do Rio de Janeiro	Hospital Universitario Pedro Ernesto

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pennation angle (degrees)	Pennation angle measured by ultrasound	First, fifth and tenth days.
Secondary	Cross-sectional area (cm2)	Cross-sectional area (cm2) measured by ultrasound	First, fifth and tenth days.
Secondary	Echogenicity (AU)	Echogenicity (AU) measured by ultrasound	First, fifth and tenth days.
Secondary	Thickness (cm)	Thickness (cm) measured by ultrasound	First, fifth and tenth days.
Secondary	Days free from mechanical ventilation	Days free from mechanical ventilation within a 28-day interval.	28-day interval.
Secondary	Extubation success rate (%)	Extubation success rate (%)	28-day interval.
Secondary	ICU mortality rate (%).	ICU mortality rate (%).	28-day interval.