Clinical trial NCT04332263: Neuromuscular Electrical Stimulation in ICU Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Intensive Care Unit Acquired Weakness
Lead sponsor: Federal University of Rio Grande do Sul
Sponsor class: OTHER
First posted: 2020-04-02
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The present study is a randomized controlled trial, which followed the recommendations proposed by the CONSORT Statement
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Total ICU time
timeFrame: Immediately after each patient discharge from the ICU (7 to 15 days after entry at the ICU, on average).
measure: Mechanical ventilation time
timeFrame: Immediately after each patient mechanical ventilation release (2 to 5 days from intubation start, on average).
measure: Weaning time
timeFrame: Immediately after each patient discharge from the ICU (7 to 15 days after entry at the ICU, on average).
measure: Change in knee extensor evoked force
timeFrame: Change from the patient ICU admission to immediately before ICU discharge (e.g., from day 1 to day 7-15, on average).
measure: Knee extensor maximal voluntary isometric contraction
timeFrame: Immediately before each patient ICU discharge (7 to 15 days after admission, on average).
measure: Knee extensor muscle quality: Real-time ultrasound 9 MHz frequency
timeFrame: Immediately after each patient ICU admission and immediately before ICU discharge (7 to 15 days on average).
measure: Rectus femoris cross-sectional area
timeFrame: Immediately after each patient ICU admission and immediately before ICU discharge (7 to 15 days on average).
measure: Knee extensors muscle thickness
timeFrame: Immediately after each patient ICU admission and immediately before ICU discharge (7 to 15 days on average).
Secondary outcomes:
measure: Sit to stand test
timeFrame: Immediately after each patient ICU discharge (7 to 15 days after admission, on average).
measure: Waking Speed Test
timeFrame: Immediately after each patient ICU discharge, until study completion (about 30 months).
measure: Heart rate variability
timeFrame: Immediately before and during NMES intervention protocols (daily, from 7 to 15 days on average).
measure: Peripheral polyneuropathy
timeFrame: Immediately before ICU discharge (7 to 15 days after admission, on average).
measure: Inflammatory profile
timeFrame: Immediately after each patient ICU admission and immediately before ICU discharge (7 to 15 days on average).
measure: Muscular biochemical markers
timeFrame: Immediately after each patient ICU admission and immediately before ICU discharge (7 to 15 days on average).
measure: Mobility (PERME)
timeFrame: Immediately before each patient ICU discharge (7 to 15 days after admission, on average).
measure: Arterial pressure
timeFrame: Daily from ICU admission to discharge day (7 to 15 days on average).
measure: Heart rate
timeFrame: Daily from ICU admission to discharge day (7 to 15 days on average).
measure: Ventilatory mode
timeFrame: Daily from ICU admission to discharge day (7 to 15 days on average).
measure: Tidal volume
timeFrame: Daily from ICU admission to discharge day (7 to 15 days on average).
measure: Ventilator frequency
timeFrame: Daily from ICU admission to discharge day (7 to 15 days on average).
measure: Sensitivity
timeFrame: Daily from ICU admission to discharge day (7 to 15 days on average).
measure: FiO2
timeFrame: Daily from ICU admission to discharge day (7 to 15 days on average).
measure: PEEP
timeFrame: Daily from ICU admission to discharge day (7 to 15 days on average).
measure: Water balance
timeFrame: Daily from ICU admission to discharge day (7 to 15 days on average).
measure: Oxygenation rate
timeFrame: Daily from ICU admission to discharge day (7 to 15 days on average).
measure: Arterial blood gas analysis
timeFrame: Daily from ICU admission to discharge day (7 to 15 days on average).
measure: Glasgow scale
timeFrame: Daily from ICU admission to discharge day (7 to 15 days on average).
measure: RAMSAY scale
timeFrame: Daily from ICU admission to discharge day (7 to 15 days on average).
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Universidade Federal do Rio Grande do Sul
state: Rio Grande Do Sul
Study officials:
affiliation: Federal University of Rio Grande do Sul
name: Marco A Vaz, PhD
role: PRINCIPAL_INVESTIGATOR
References: