Using electrical stimulation to prevent muscle weakness in critically ill patients
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.
This study tests if using electrical stimulation can help prevent muscle weakness in critically ill patients on mechanical ventilation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Pontificia Universidad Catolica de Chile Academic / other |
| Locations | 1 site (Santiago, Santiago Metropolitan) |
| Trial ID | NCT05536531 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of neuromuscular electrical stimulation (NMES) to prevent respiratory muscle weakness in critically ill patients who are on mechanical ventilation. It aims to address the rapid muscle wasting that occurs within the first 18 to 69 hours of mechanical ventilation, which can lead to prolonged hospital stays and increased mortality risk. By applying NMES to non-cooperative patients, the study seeks to stimulate muscle contraction and potentially improve outcomes through the release of myokines, which may have systemic benefits. The study will evaluate the effectiveness of NMES in preventing muscle atrophy and its association with changes in myokine levels.
Who should consider this trial
Good fit: Ideal candidates include critically ill patients aged 18 and older who are connected to invasive mechanical ventilation and are in a non-cooperative state due to deep sedation.
Not a fit: Patients with pre-existing neuromuscular diseases, obesity, or those under 18 years old may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce muscle weakness and improve recovery times for critically ill patients on mechanical ventilation.
How similar studies have performed: While the use of NMES in critically ill patients is a promising approach, this specific application has not been extensively studied, making it a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Consecutively admission to Christus ICU between March 2021 and December 2021. 2. Connected to invasive MV within the previous 24-48 hours 3. Deep sedation \[non-cooperative state; Sedation-Agitation Scale (SAS) 1 or 2\]. 4. 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). 5. Written informed consent provided by patient/surrogate Exclusion Criteria: 1. Age \< 18 years 2. Pregnancy 3. Obesity (Body Mass Index \>35 kg/m2) 4. Pre-existing Neuromuscular diseases (e.g., myasthenia Gravis, Guillain-Barré disease) 5. Diseases with systemic vascular involvement such as systemic lupus erythematosus. 6. Use of neuromuscular blockers 7. Technical obstacles to the implementation of NMES such as bone fractures or skin lesions (e.g., burns) 8. End-stage malignancy 9. Presence of cardiac pacemakers 10. Diagnosis of brain death.
Where this trial is running
Santiago, Santiago Metropolitan
- Pontificia Universidad Católica de Chile — Santiago, Santiago Metropolitan, Chile (Recruiting)
Study contacts
- Principal investigator: Yorschua Jalil, PT, MSc — Facultad de Medicina, Pontificia Universidad Católica de Chile
- Study coordinator: Yorschua Jalil, PT, MSc
- Email: yfjalil@uc.cl
- Phone: 96691771
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.