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New treatment option for Muscle Weakness or Atrophy
Official title NMES Role to Prevent Respiratory Muscle Weakness in Critically Ill Patients and Its Association to Changes in Myokines.
ClinicalTrials.gov ID: NCT05536531
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Written informed consent provided by patient/surrogate
You likely can't join if
- Age \< 18 years
- Pregnancy
- Obesity (Body Mass Index \>35 kg/m2)
- Pre-existing Neuromuscular diseases (e.g., myasthenia Gravis, Guillain-Barré disease)
- Diseases with systemic vascular involvement such as systemic lupus erythematosus.
- Use of neuromuscular blockers
See the full eligibility criteria
- 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
- Age \< 18 years
- Pregnancy
- Obesity (Body Mass Index \>35 kg/m2)
- Pre-existing Neuromuscular diseases (e.g., myasthenia Gravis, Guillain-Barré disease)
- Diseases with systemic vascular involvement such as systemic lupus erythematosus.
- Use of neuromuscular blockers
- Technical obstacles to the implementation of NMES such as bone fractures or skin lesions (e.g., burns)
- End-stage malignancy
- Presence of cardiac pacemakers
- Diagnosis of brain death.
The study team makes the final eligibility decision.
Where it's taking place
- Santiago, Santiago Metropolitan, Chile
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Santiago, Santiago Metropolitan, Chile. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.