Clinical Trials Directory

Trials / Unknown

UnknownNCT04382378

Effects of NMES in Critically Ill Patients

Effects of Different Regimen Protocols of NMES in COVID 19 Critically Ill Patients

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
120 (estimated)
Sponsor
Escola Superior de Ciencias da Saude · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

Muscle wasting occurred early and rapidly in critically ill patients. Early therapeutic strategies to either maintain muscle structure and function should be encouraged. Neuromuscular electrical stimulation (NMES) is an attractive intervention to maintain muscle mass and strength in critically ill patients during the first week of ICU stay. This study will test the hypothesis that the number of contraction per day evoked by NMES in the first two weeks of illness may influence in muscle wasting, with beneficial effects on the physical and functional status in mechanically ventilated patients.

Detailed description

Patients with prolonged mechanical ventilation require deep sedation and mechanical ventilation, factors predisposing to the development of skeletal muscle wasting and acute muscle atrophy. Strategies to attenuate this process must be used. The neuromuscular electrostimulation (NMES) leads to the application of electrical currents in the skin aiming at muscle contraction, has beneficial effects for the population of critical patients. However, the number of contractions induced by NMES to attenuate the loss of muscle mass in this population is not yet established. This randomized controlled trial with 120 patients that will be randomized to one of the 3 study groups: 100 continuous daily contractions (100Cd), 50 continuous daily contractions (50Cd) and control group. Muscle thickness, NMES-induced strength, and clinical and functional parameters at the time of discharge from the ICU and hospital discharge will be assessed daily. The results of this project will provide an important contribution to the understanding of the mechanisms associated with NMES treatment as a tool to minimize the effects of muscle disuse, as well as providing scientific support for the clinical use of this resource in the treatment in the light of the policies' health system.

Conditions

Interventions

TypeNameDescription
DEVICEneuromuscular electrical stimulationapplication of an electric current through electrodes placed on the skin over the targeted musclesto induce skeletal muscle contractions

Timeline

Start date
2021-02-01
Primary completion
2021-09-30
Completion
2021-12-31
First posted
2020-05-11
Last updated
2021-03-15

Locations

1 site across 1 country: Brazil

Source: ClinicalTrials.gov record NCT04382378. Inclusion in this directory is not an endorsement.