Role of Neuromuscular Electrical Stimulation to Prevent Respiratory Muscle Weakness in Critically Ill Patients and Its Association to Changes in Myokines Profile. a Randomized Clinical Trial.

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Particularly, muscle respiratory wasting will occur early (18 to 69 hours) in up to 60% of patients with mechanical ventilation (MV), leading rapidly to diaphragmatic weakness, which is associated with prolonged MV use, longer ICU and hospital stay, and higher mortality risk. Sepsis and muscle inactivity, derived from sedation and MV use, are key driver mechanisms for developing these consequences, which can be avoided through early physical activation. However, exercise is limited at the early stages of care, where sedation and MV are needed, delaying muscle activation. Neuromuscular electrical stimulation (NMES) represents an alternative to achieve early muscle contraction in non-cooperative patients, being able to prevent local muscle wasting and, according to some reports, has the potential to shorten the time on MV, suggesting a systemic effect through myokines, a diverse range of cytokines and chemokines secreted by myocytes during muscle contraction. However, no studies have evaluated whether NMES applied to peripheral muscles can exert distant muscle effects over the diaphragm, ameliorating its weakness and if this protective profile is associated with myokine's change in ICU patients. This proposal comprises a randomized controlled study of NMES applied twice daily, for three days, compared to standard care (no NMES). Thirty-two patients will be recruited in the first 48 hours after MV and randomly assigned to the control group or NMES group (16 subjects each). Muscle characterization of quadriceps and diaphragm will be performed at baseline (Day 1, before the first NMES session) and after the last NMES session (morning of day 4). Myokine measurements \[IL-1, IL-6, IL-15, Brain-Derived Neurotrophic Factor (BDNF), Myostatin and Decorin\], through blood serum obtained from peripheric blood samples, will be performed just before starting NMES (T0) at the end of the session (T0.5), and 2 and 6 hours later (T2 and T6). These myokine curves will be repeated on days 1 and 3 at the first NMES session of the day. The Control group will be assessed in the same way and timing, except that blood samples will be at T0 and T6. Additionally, functional outcomes such as MV time and ICU length of stay will be registered for all patients at ICU discharge. Standard care won´t be altered.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Consecutively admission to Christus ICU between March 2021 and December 2021.

• Connected to invasive MV within the previous 24-48 hours

• Deep sedation \[non-cooperative state; Sedation-Agitation Scale (SAS) 1 or 2\].

• ICU-acquired weakness risk (One of the following risk factors: the need for invasive MV, sepsis, hyperglycemia, APACHE II admission score \>13 pts, use of corticosteroids, and/or muscle inactivity due to deep sedation).

• Written informed consent provided by patient/surrogate

Locations
Other Locations
Chile
Pontificia Universidad Católica de Chile
RECRUITING
Santiago
Contact Information
Primary
Yorschua Jalil, PT, MSc
yfjalil@uc.cl
96691771
Backup
Alejandro Bruhn, MD, PhD
alejandrobruhn@gmail.com
23545649
Time Frame
Start Date: 2022-07-11
Estimated Completion Date: 2025-02-28
Participants
Target number of participants: 32
Treatments
Experimental: NMES group
NMES will be implemented simultaneously on quadriceps femoris muscles of both lower limbs using an electrical stimulator (TRAINFES 6 ADVANCED, Biomedical devices Spa, Santiago, Chile). Four rubber surface electrodes will be placed over motor points. However, since the electrodes will cover big proportion of muscle surface, anatomical distribution of the belly muscle plus visible contraction of it will be considered for correct setting. The stimulation will be delivered by biphasic current, symmetric (compensated) impulses of 45-50 Hz frequency, 400 μsec pulse duration. With a stimulus duration of 25 minutes, and an on-off programming of 5 seconds on (including 0.8 second rise time, 3.4 seconds of plateau and 0.8 second of fall time) and 5 seconds off, at current intensities able to cause maximal visible contractions. The session duration will be 30 minutes and will be applied twice a day.
No_intervention: Control
Sham NMES will not be provided. Standard care won´t be altered and passive mobilization will be performed according to routine ICU procedures.
Related Therapeutic Areas
Sponsors
Leads: Pontificia Universidad Catolica de Chile

This content was sourced from clinicaltrials.gov