Muscle Effects Of Neuromuscular Electrostimulation In Mechanically Ventilated Patients In An Icu (NCT06409611) | Clinical Trial Compass
CompletedNot Applicable
Muscle Effects Of Neuromuscular Electrostimulation In Mechanically Ventilated Patients In An Icu
Brazil22 participantsStarted 2024-05-01
Plain-language summary
To prevent the development of ICUAW, both early mobilization and neuromuscular electrical stimulation (NMES) have been shown to prevent muscle atrophy in critically ill patients by preserving muscle mass. Furthermore, it is of great value that muscle assessment using kinesiological ultrasound becomes routine to monitor this patient's profile with regard to strength, muscle quality and muscle mass. Our objective is to evaluate the muscular changes promoted by NMES in patients under mechanical ventilation. This is a randomized clinical trial study, which will perform NMES sessions for at least 7 days in mechanically ventilated patients. They will also undergo ultrasound assessments of the quadriceps. Patients will be divided into a control group and an NMES group. In addition, general information recorded in the medical record will be collected, such as basic characteristics, laboratory tests and general assessments.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age ≥18 years;
. On mechanical ventilation in the first 24 hours;
. Provision of written, informed and/or agreed consent for a family member.
Exclusion criteria
. Trauma to the lower limb;
. History of neurological, neuromuscular or debilitating diseases;
. Spinal cord injury;
. Rhabdomyolysis;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial looked at something called the 'pennation angle' in muscles — can you explain what that measurement tells us about muscle health, and why it matters for someone who's been on a ventilator in the ICU?
2Since this trial is already completed, has the data been published or shared anywhere, and could the findings about neuromuscular electrostimulation change how my care team approaches preventing muscle weakness during mechanical ventilation?
3Neuromuscular electrostimulation is listed as having no formal phase, which suggests it's more of a device or technique study — does that mean we know less about its risks and benefits compared to a drug that's gone through standard phase trials?
4If neuromuscular electrostimulation did show a meaningful effect on muscle structure in this study, is that something my care team could realistically offer me, or is it still considered experimental in this setting?
5Given that ICU-acquired weakness can have serious long-term effects on recovery, what are the current standard approaches your team uses to address it, and how would the findings from a study like this fit into that plan?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.