Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05536531

NMES Role to Prevent Respiratory Muscle Weakness in Critically Ill Patients and Its Association to Changes in Myokines.

Led by Pontificia Universidad Catolica de Chile · Updated on 2025-01-14

32

Participants Needed

1

Research Sites

137 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

NMES Role to Prevent Respiratory Muscle Weakness in Critically Ill Patients and Its Association to Changes in Myokines.

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Consecutively admitted to Christus ICU between March 2021 and December 2021
  • Connected to invasive mechanical ventilation within the previous 24-48 hours
  • Deep sedation with non-cooperative state; Sedation-Agitation Scale (SAS) 1 or 2
  • At risk of ICU-acquired weakness with at least one risk factor: need for invasive mechanical ventilation, sepsis, hyperglycemia, APACHE II admission score >13, corticosteroid use, or muscle inactivity due to deep sedation
  • Written informed consent provided by patient or surrogate
Not Eligible

You will not qualify if you...

  • Age under 18 years
  • Pregnancy
  • Obesity with Body Mass Index over 35 kg/m2
  • Pre-existing neuromuscular diseases such as myasthenia gravis or Guillain-Barré disease
  • Diseases involving systemic vascular problems like systemic lupus erythematosus
  • Use of neuromuscular blockers
  • Physical conditions preventing NMES such as bone fractures or skin lesions (e.g., burns)
  • End-stage malignancy
  • Presence of cardiac pacemakers
  • Diagnosis of brain death

AI-Screening

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Trial Site Locations

Total: 1 location

1

Pontificia Universidad Católica de Chile

Santiago, Santiago Metropolitan, Chile, 8970117

Actively Recruiting

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Research Team

Y

Yorschua Jalil, PT, MSc

CONTACT

A

Alejandro Bruhn, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

PREVENTION

Number of Arms

2

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