Intensive Care Unit Acquired Weakness Clinical Trial
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
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.
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. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01885442 -
TryCYCLE: A Pilot Study of Early In-bed Leg Cycle Ergometry in Mechanically Ventilated Patients
|
N/A | |
| Completed |
NCT05303623 -
The Effect of Inspiratory Muscle Training on Diaphragmatic Function in Mechanically Ventilated Patients
|
N/A | |
| Recruiting |
NCT04541602 -
Detection of Neuromuscular Complications in Critically Ill Patients
|
||
| Completed |
NCT04589910 -
Measuring Thickness of the Normal Diaphragm in Children Via Ultrasound.
|
N/A | |
| Completed |
NCT05297188 -
The Effect of Ergonomic Sleep Mask Usage on Patients' Sleep Quality and Comfort
|
||
| Completed |
NCT04833621 -
Is NMES Treatment in Sepsis/ Septic Shock Patients Protective in Development of ICU-AW?
|
N/A | |
| Active, not recruiting |
NCT03471247 -
CYCLE: A Randomized Clinical Trial of Early In-bed Cycling for Mechanically Ventilated Patients
|
N/A | |
| Completed |
NCT05282576 -
Effect of Neurophysiological Facilitation Techniques in Intensive Care Patients
|
N/A | |
| Completed |
NCT04633421 -
PRotEin Provision in Critical IllneSs
|
N/A | |
| Completed |
NCT02391103 -
Effects of Neuromuscular Electrical Stimulation on Muscle Mass and Strength in Critically Ill Patients After Cardiothoracic Surgery
|
N/A | |
| Completed |
NCT04154995 -
Intensive Care Unit Recovery
|
||
| Not yet recruiting |
NCT06409611 -
MUSCLE EFFECTS OF NEUROMUSCULAR ELECTROSTIMULATION IN MECHANICALLY VENTILATED PATIENTS IN AN ICU
|
N/A | |
| Completed |
NCT02377830 -
CYCLE Pilot Randomized Trial
|
Phase 2 | |
| Completed |
NCT04435080 -
Physical Rehabilitation in ICU in ARDS Patients With COVID-19
|
||
| Terminated |
NCT05474157 -
Sarcopenia and Related Factors in Coronavirus Disease 2019 (COVID-19) Following Intensive Care
|
||
| Completed |
NCT04459533 -
Sparing in Neuromuscular Blockade in COVID 19 ICU
|
||
| Recruiting |
NCT05868070 -
Feasibility and Safety of In-bed Cycling/Stepping in Critically Ill Patients
|
N/A | |
| Completed |
NCT05591248 -
Virtual Reality Rehabilitation on the Intensive Care Unit for Critically Ill Patients
|
N/A | |
| Withdrawn |
NCT04249141 -
Determinants of Implementation Success Coordinating Ventilator, Early Ambulation and Rehabilitation Efforts
|
||
| Not yet recruiting |
NCT05074862 -
Effects of Ketosis on Muscle Kinetics and Signaling During Critical Illness.
|
Phase 2 |