Neuromuscular Electrical Stimulation in ICU Patients

NCT ID: NCT04332263

Last Updated: 2024-06-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2024-06-06

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Neuromuscular Electrical Stimulation - NMES

NMES will be applied bilaterally on the quadriceps femoris muscle of ICU patients. An electrical stimulation system and an ICU-designed dynamometer will be used with the patients lying in bed, with the hips and the knees flexed at 60 and 90 degrees, respectively. Supramaximal single-pulse's peak force will be used to determine the NMES intervention level. NMES (alternating biphasic current, stimulation frequency = 80 Hz, 1 ms pulse duration) will be used to evoke tetanic forces (EF) at 50% of the supra-maximal single-pulse EF (i.e., 10-12% of a maximal voluntary isometric contraction). NMES protocol will be performed five times a week, lasting 20 min. Muscle fatigue will be evaluated every 5 min of the intervention, and will be determined as a 10 % decrease in the single-pulse evoked torque between the evoked force produced pre- and during the NMES protocol. If and when a 10% reduction of the single-pulse EF is achieved, the intervention protocol will be terminated before the 20 min.

Group Type: EXPERIMENTAL

Neuromuscular Electrical Stimulation - NMES

Intervention Type: OTHER

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.

Control Group - CG

The control group (CG) will only perform conventional physiotherapy and will not receive any NMES training, but will be evaluated through the same evaluations and in the same moments of the two above mentioned intervention groups. Conventional physiotherapy will be given to all three groups.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

Artificial electrical stimulation

Eligibility Criteria

Inclusion Criteria

• Patients with any clinical condition hospitalized in the ICU, which are monitored by the Physiotherapy Service:
• Cerebrovascular diseases
• Other bacterial diseases
• Circulatory and respiratory diseases
• Digestive and abdominal diseases
• Liver diseases
• Time between the patient's ICU entry and the onset of the NMES intervention less than one week.

Patients may be in mechanical ventilation, non-invasive ventilation, oxygen therapy or oxygen ambient ventilation (no ventilatory add). Patients re-admitted to the ICU within the same hospitalization period (i.e., did not leave the hospital) may also be included, as well as patients with previous tracheostomy.

Exclusion Criteria

• Previously diagnosed neuromuscular diseases:
• ALS
• Guillain Barre
• Chronic stroke
• TRM
• End-stage malignant disease
• Lower limbs' amputation
• Body mass index above 40 kg/m2
• Cachexia (defined as the presence of chronic disease and weight loss ≥ 5% in a period shorter than 12 months or BMI < 20 kg/m2, associated with at least three of the following criteria: (1) decreased muscle strength; (2) fatigue; (3) anorexia; (4) reduction of fat free mass index; and (5) biochemical abnormalities such as inflammation, anemia or reduction of serum albumin concentration).
• Lesions on the skin at the electrode placement and/or dynamometer support points
• Post-operative transplantation
• Patients using a neuromuscular blocker
• Hemodynamic instability (nora > 10; ABCDE criteria)
• Height < 1.50m
• Rhabdomyolysis

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federal University of Rio Grande do Sul

OTHER

Sponsor Role: lead

Responsible Party

Marco Aurélio Vaz, PhD

Full Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marco A Vaz, PhD

Role: PRINCIPAL_INVESTIGATOR

Federal University of Rio Grande do Sul

Locations

Universidade Federal do Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, Brazil

Countries

Brazil

Other Identifiers

36588914.4.1001.5347

Identifier Type: -

Identifier Source: org_study_id