NMES Role to Prevent Respiratory Muscle Weakness in Critically Ill Patients and Its Association to Changes in Myokines.
Launched by PONTIFICIA UNIVERSIDAD CATOLICA DE CHILE · Sep 8, 2022
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying the use of a treatment called neuromuscular electrical stimulation (NMES) to help prevent muscle weakness in critically ill patients who are on mechanical ventilation (MV). When patients are on MV, their muscles, especially those used for breathing, can weaken quickly, which can lead to longer hospital stays and higher risks of complications. The trial aims to see if applying NMES to the muscles in the legs can help improve muscle strength in the diaphragm (the main muscle for breathing) and if this is related to changes in certain proteins in the blood called myokines, which are released during muscle activity.
To be eligible for this trial, participants must be adults (18 years or older) who have been admitted to the ICU and have been on MV for 24-48 hours. They should also be deeply sedated and at risk of developing muscle weakness due to their condition. Those who join the study will be randomly assigned to either receive NMES twice a day for three days or continue with standard care. Participants can expect to have their muscle strength and blood samples checked at different points during the study. Importantly, this trial is focusing on finding a way to protect patients from muscle weakness while they are receiving critical care, which could improve their recovery and overall health.
Gender
ALL
Eligibility 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.
About Pontificia Universidad Catolica De Chile
Pontificia Universidad Católica de Chile is a prestigious academic institution renowned for its commitment to excellence in education, research, and healthcare. As a clinical trial sponsor, the university leverages its extensive expertise in medical sciences to advance innovative research initiatives aimed at improving patient outcomes. With a strong emphasis on ethical standards and scientific rigor, the institution collaborates with multidisciplinary teams to conduct high-quality clinical trials that contribute to the advancement of medical knowledge and the development of effective therapeutic interventions. Its dedication to fostering a culture of inquiry and community engagement positions Pontificia Universidad Católica de Chile as a leader in the field of clinical research in Latin America.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Santiago, , Chile
Patients applied
Trial Officials
Yorschua Jalil, PT, MSc
Principal Investigator
Facultad de Medicina, Pontificia Universidad Católica de Chile
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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