Clinical trial NCT06409611: MUSCLE EFFECTS OF NEUROMUSCULAR ELECTROSTIMULATION IN MECHANICALLY VENTILATED PATIENTS IN AN ICU
Official title: MUSCLE EFFECTS OF NEUROMUSCULAR ELECTROSTIMULATION IN MECHANICALLY VENTILATED PATIENTS IN AN ICU
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Intensive Care Unit Acquired Weakness
Keywords: neuromuscular electrical stimulation
Intensive Care Unit Acquired Weakness
Lead sponsor: Universidade Federal do Rio de Janeiro
Sponsor class: OTHER
Collaborators: name: Hospital Universitario Pedro Ernesto
First posted: 2024-05-10
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: fes/parametros
Primary purpose: TREATMENT

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 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.

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pennation angle (degrees)
timeFrame: First, fifth and tenth days.
Secondary outcomes:
measure: Cross-sectional area (cm2)
timeFrame: First, fifth and tenth days.
measure: Echogenicity (AU)
timeFrame: First, fifth and tenth days.
measure: Thickness (cm)
timeFrame: First, fifth and tenth days.
measure: Days free from mechanical ventilation
timeFrame: 28-day interval.
measure: Extubation success rate (%)
timeFrame: 28-day interval.
measure: ICU mortality rate (%).
timeFrame: 28-day interval.
Other outcomes:
Locations:
city: Rio De Janeiro
country: Brazil
facility: Pedro Ernesto University Hospital
Study officials:
References: