Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID05536531

Role of Neuromuscular Electrical Stimulation to Prevent Respiratory Muscle Weakness in Critically Ill Patients and Its Association with Myokine Changes: A Randomized Clinical Trial

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

32

Participants Needed

1

Research Sites

137 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research focuses on critically ill patients in the Intensive Care Unit (ICU) who often experience rapid muscle wasting, especially respiratory muscles, within 18 to 69 hours of mechanical ventilation (MV). This muscle weakness, particularly of the diaphragm, is linked to longer MV use, extended ICU and hospital stays, and higher risk of death. The study explores how early physical activation can prevent these issues but notes that exercise is often limited early on due to sedation and MV. Neuromuscular electrical stimulation (NMES) offers a way to stimulate muscles in patients who cannot actively exercise, potentially preventing muscle wasting and reducing MV duration through effects involving muscle-secreted proteins called myokines. The trial will investigate whether NMES applied to peripheral muscles can also protect the diaphragm and alter myokine levels in ICU patients. The study is a randomized controlled trial involving 32 patients who have been on invasive MV for 24 to 48 hours. Participants will be randomly assigned to receive NMES twice daily for three days or to a control group receiving standard care without NMES. Muscle assessments of the quadriceps and diaphragm will be done at the start (Day 1) and after completing NMES sessions (Day 4 morning). Blood samples will be taken to measure several myokines at multiple times during the first and third days of NMES sessions for the stimulated group, and at two time points for the control group. Standard ICU care, including passive mobilization, will continue unchanged for all patients. Participants will undergo muscle ultrasound and diaphragmatic strength testing using tracheal twitch pressure measurements. Blood serum samples will be collected to analyze myokine changes over time. The study will also record functional outcomes including total time on mechanical ventilation and length of ICU stay at discharge. The main outcomes measured are changes in diaphragmatic strength and thickness fraction from Day 1 to Day 3. This study aims to determine if NMES can prevent respiratory muscle weakness early in critical illness and if this effect is linked to changes in myokine profiles.

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

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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

A

Alejandro Bruhn, MD, PhD

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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Published Research Related To This Trial

Coexistence and Impact of Limb Muscle and Diaphragm Weakness at Time of Liberation from Mechanical Ventilation in Medical Intensive Care Unit Patients.

Martin Dres, Bruno-Pierre Dubé, Julien Mayaux...

https://pubmed.ncbi.nlm.nih.gov/27310484

Effects of neuromuscular electrical stimulation on cytokines in peripheral blood for healthy participants: a prospective, single-blinded Study.

Alexander D Truong, Michelle E Kho, Roy G Brower...

https://pubmed.ncbi.nlm.nih.gov/26475418

Electrical muscle stimulation prevents critical illness polyneuromyopathy: a randomized parallel intervention trial.

Christina Routsi, Vasiliki Gerovasili, Ioannis Vasileiadis...

https://pubmed.ncbi.nlm.nih.gov/20426834