NCT04332263

Neuromuscular Electrical Stimulation in ICU Patients

Development and Application of a Portable Electrical Stimulator With Biofeedback to Increase Mobility and Improve the Neuromuscular Function of Critical Adult Patients in Intensive Care Units

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Federal University of Rio Grande do Sul · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of the present study is to evaluate the effects of neuromuscular electrical stimulation (NMES) combined with conventional physiotherapy (Experimental Group), compared to conventional physiotherapy only (Control Group) in critically ill Intensive Care Unit (ICU) patients, by means of a randomized controlled clinical trial. The investigators expect that the NMES program will be able to reduce muscle structure and function losses compared to control group, and will improve muscle quality faster, will reduce the ventilation time and the total time spent at the ICU, as well as improve functionality of these patients. In addition, the researchers expect to understand which mechanisms determine such adaptations in the musculoskeletal system of these patients.

Detailed description

The aim of the present study is to evaluate the effects of neuromuscular electrical stimulation (NMES) combined with conventional physiotherapy (Experimental Group), compared to conventional physiotherapy only (Control Group) in critically ill ICU patients, by means of a randomized controlled clinical trial. Primary outcomes evaluated during ICU patient's hospitalization are (1) the time spent in the ICU; (2) time of mechanical ventilation; (3) time and success of weaning (up to 48 hours), (4) the isometric torque from contractions artificially generated by NMES and evaluated by dynamometry; (5) muscle morphology and quality by means of ultrasonography. Secondary outcomes include (6) the sit and stand test; (7) gait speed test; (8) autonomic control (heart rate variability); (9) peripheral polyneuropathy by means of MRC scale; (10) Inflammatory profile - inflammatory (IL-6 and TNF-α) and anti-inflammatory (IL-10) cytokines; (11) blood muscular biochemical markers (IGF1, LDH, CK); (12) predictive mortality index for patients admitted to the ICU (SAPS 3); (13) survival rate; and (14) mobility (PERME). After discharge from the ICU or as soon as the patients are able to perform force voluntarily, the maximum voluntary torque will also be evaluated by means of dynamometry. Also, clinical data, hemodynamic variables, dosage of neuromuscular blockers and corticosteroids, blood glucose levels in the morning, daily water balance, oxygenation index, arterial blood gases, mechanical ventilator parameters, Glasgow scale, sedation scale (RASS), will be recorded daily. The investigators expect that the NMES program will be able to reduce muscle structure and function losses compared to control group, and will improve muscle quality, will reduce the ventilation time and the total time spent at the ICU, as well as improve functionality of these patients. In addition, the researchers expect to understand which mechanisms determine such adaptations in the musculoskeletal system of these patients.

Conditions

• Intensive Care Unit Acquired Weakness

Interventions

Type	Name	Description
OTHER	Neuromuscular Electrical Stimulation - NMES	NMES will be applied through an alternating biphasic current, with a stimulation frequency of 80 Hz and 1 ms pulse duration. Tetanic evoke forces (EF) at a 50% level of a supra-maximal single-pulse peak EF (i.e., 10-12% of a maximal voluntary isometric contraction) will be used. NMES protocol will be performed five times a week, lasting 20 minutes. Muscle fatigue will be evaluated every 5 min of the intervention, and will be used to determine the NMES protocol termination. A 10 % decrease in the single-pulse evoked torque between the evoked force produced pre- and during the NMES protocol will be used to terminate the fatigue protocol.

Timeline

• Start date: 2022-03-01
• Primary completion: 2022-03-01
• Completion: 2024-06-06
• First posted: 2020-04-02
• Last updated: 2024-06-10

Locations

1 site across 1 country: Brazil