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
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Intensive Care Unit Acquired Weakness
- Sponsor
- Federal University of Rio Grande do Sul
- Enrollment
- 56
- Locations
- 1
- Primary Endpoint
- Mechanical ventilation time
- Status
- Terminated
- Last Updated
- last year
Overview
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.
Investigators
Marco Aurélio Vaz, PhD
Full Professor
Federal University of Rio Grande do Sul
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:
- •Guillain Barre
- •Chronic stroke
- •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
Outcomes
Primary Outcomes
Mechanical ventilation time
Time Frame: Immediately after each patient mechanical ventilation release (2 to 5 days from intubation start, on average).
Total time of mechanical ventilation, from patient intubation to weaning, will be collected from the patient's medical record.
Weaning time
Time Frame: Immediately after each patient discharge from the ICU (7 to 15 days after entry at the ICU, on average).
Time and success of weaning post-mechanical ventilation, from weaning to ICU discharge, will be collected from the medical record of the patient. The maintenance of spontaneous ventilation for at least 48 hours after discontinuation of artificial ventilation will be considered a successful weaning.
Change in knee extensor evoked force
Time Frame: Change from the patient ICU admission to immediately before ICU discharge (e.g., from day 1 to day 7-15, on average).
Knee extensor evoked force (EF) will be evaluated by means of isometric tests using a stainless steel dynamometry system instrumented with a load cell. EF will be evaluated through evoked contractions of the knee extensor muscles generated by supramaximal electrical stimuli with symmetrical rectangular biphasic current, applied in the form of single pulses (phase duration=1 ms, pulse duration=2 ms). At the beginning of the tests, the singular pulses will be applied with a manual trigger, and current intensity will be gradually increased (maximum 180 mA, inter-pulse interval = 3-5 second), until no further EF increase is observed. The current intensity required to reach the peak EF will then be increased by 10% to ensure supra-maximal stimulus during the tests. Three singular pulses will be applied and EF will be obtained by the mean value from the three evoked contractions. The change in knee extensor EF will be calculated as the difference in EF from ICU admission to ICU discharge.
Knee extensor maximal voluntary isometric contraction
Time Frame: Immediately before each patient ICU discharge (7 to 15 days after admission, on average).
Maximal knee extensor strength capacity during voluntary effort will be assessed only when the patient is discharged (POST) from ICU, by performing maximum voluntary isometric contractions (MVICs). To do so, once properly positioned on the dynamometer, subjects will perform three knee extensor MVICs, maintaining each contraction for a 5 sec period each. Subjects will be instructed to perform the contractions without any visual feedback, rapidly increasing the effort until they reach the maximum torque production, which should be maintained until the verbal command to cease contraction. Two-minute intervals will be given between contractions. The highest torque value recorded during the three MVICs will be adopted as the maximum voluntary effort (maximal torque). Mean and standard deviation values from the MVICs will be calculated for the experimental groups.
Total ICU time
Time Frame: Immediately after each patient discharge from the ICU (7 to 15 days after entry at the ICU, on average).
Total time of stay at the ICU, from admission to discharge (an average of 7 up to 15 days). Total ICU time will be collected from the patient's medical record.
Knee extensor muscle quality: Real-time ultrasound 9 MHz frequency
Time Frame: Immediately after each patient ICU admission and immediately before ICU discharge (7 to 15 days on average).
Real-time ultrasound (Vivid-I, General Electric, USA) obtained with a linear array probe (4 cm wide) and a 9 MHz sampling frequency will be used for the evaluation of muscle quality. Images from the rectus femoris (RF) muscle will be obtained with the participants at rest. Ultrasound images will be captured in the muscle's transverse plane, at 50% of the muscle's belly. To ensure the ultrasound images comparison at different times, the brightness and contrast settings will be maintained at 50% during all evaluations. Muscle quality will be determined using a standard function of the Image-J (National Institute of Health, USA) software. A region of interest that includes as much muscle area as possible, avoiding the fascia, will be selected from the RF muscle images. Muscle quality will be determined by analysing the image's average gray scale, which ranges from total black (0) to total white (255), and mean values from three ultrasound images will be determined.
Rectus femoris cross-sectional area
Time Frame: Immediately after each patient ICU admission and immediately before ICU discharge (7 to 15 days on average).
RF cross-sectional area (CSA) will be captured at rest in the muscle's transverse plane, at 70% of the muscle belly. The probe will be positioned transversely to the muscle belly, with the image depth adjusted so that both the RF superficial and deep aponeuroses can be visualized. RF CSA will be obtained through the analysis of these transverse images. A standard function of the Image-J (National Institute of Health, USA) software will be used, which allows the demarcation of the muscular perimeter (excluding the aponeuroses), and calculates the internal selected area (cm2). The mean CSA value from three images will be calculated for each group at each time-point of the study.
Knee extensors muscle thickness
Time Frame: Immediately after each patient ICU admission and immediately before ICU discharge (7 to 15 days on average).
Muscle thickness (MT) will be obtained at rest from ultrasound images of the RF, vastus intermedius (VI), vastus lateralis (VL) and vastus medialis (VM) muscles. Ultrasound images will be captured at 50% of the RF, VI and VL muscle bellies, and at 70% of the VM length. MT will be obtained by image analysis in the Image-J software (National Institute of Health, USA). Five equidistant measurements will be taken from the superficial to deep aponeurosis of the VI, VL and VM muscles. RF diameter will be obtained from the transverse image obtained for muscle quality evaluation and will represent its MT. The mean value of the five measures of the VI, VL and VM muscles will be calculated for each image. The mean MT value from three ultrasound images will be calculated and will be used as the MT from each evaluated muscle (in cm).
Secondary Outcomes
- Peripheral polyneuropathy(Immediately before ICU discharge (7 to 15 days after admission, on average).)
- Sit to stand test(Immediately after each patient ICU discharge (7 to 15 days after admission, on average).)
- Mobility (PERME)(Immediately before each patient ICU discharge (7 to 15 days after admission, on average).)
- Waking Speed Test(Immediately after each patient ICU discharge, until study completion (about 30 months).)
- Heart rate variability(Immediately before and during NMES intervention protocols (daily, from 7 to 15 days on average).)
- Inflammatory profile(Immediately after each patient ICU admission and immediately before ICU discharge (7 to 15 days on average).)
- Heart rate(Daily from ICU admission to discharge day (7 to 15 days on average).)
- Ventilatory mode(Daily from ICU admission to discharge day (7 to 15 days on average).)
- Tidal volume(Daily from ICU admission to discharge day (7 to 15 days on average).)
- Sensitivity(Daily from ICU admission to discharge day (7 to 15 days on average).)
- Muscular biochemical markers(Immediately after each patient ICU admission and immediately before ICU discharge (7 to 15 days on average).)
- Arterial pressure(Daily from ICU admission to discharge day (7 to 15 days on average).)
- Water balance(Daily from ICU admission to discharge day (7 to 15 days on average).)
- RAMSAY scale(Daily from ICU admission to discharge day (7 to 15 days on average).)
- Ventilator frequency(Daily from ICU admission to discharge day (7 to 15 days on average).)
- FiO2(Daily from ICU admission to discharge day (7 to 15 days on average).)
- PEEP(Daily from ICU admission to discharge day (7 to 15 days on average).)
- Oxygenation rate(Daily from ICU admission to discharge day (7 to 15 days on average).)
- Arterial blood gas analysis(Daily from ICU admission to discharge day (7 to 15 days on average).)
- Glasgow scale(Daily from ICU admission to discharge day (7 to 15 days on average).)