AI Based Muscular Ultrasound to Assess Intensive Care Unit-acquired Weakness (NCT06765551) | Clinical Trial Compass
RecruitingNot Applicable
AI Based Muscular Ultrasound to Assess Intensive Care Unit-acquired Weakness
Germany50 participantsStarted 2024-10-01
Plain-language summary
The aim of this observational case-control study is to investigate, whether artificial intelligence can detect ultrasound-derived imaging characteristics typical for intensive care unit-acquired weakness. The main questions it aims to answer are:
1. Is the evaluation of specific parameters of neuromuscular ultrasound using AI-based image analysis suitable for detecting and monitoring critically ill ICU patients with ICUAW?
2. Do the results of AI-based ultrasound image analysis correlate with:
(A) the severity of ICUAW (B) the visual grading of muscle echogenicity (C) the 30- and 90-day-outcome?
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:
* Patients aged 18 years or above
* Major elective surgery, e.g. cardiothoracic or abdominal surgery
* Expected ICU stay \>1 day postoperatively
* Healthy, age-machted subjects without ICUAW (recruited from staff of the department of anesthesiology and intensive care medicine)
Exclusion Criteria:
* No informed consent
* Emergency surgery
* Previous participation in the same study
* Preexisting neuromuscular disease
* Preexisting central nervous system disease with residual neuromuscular impairment (e.g. cerebral haemorrhage, stroke, brain tumor)
* High-dose glucocorticoid therapy (\>300 mg hydrocortisone or equivalent per day) before or during particiation in the study
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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.
What they're measuring
1
Incidence of abnormalities of muscle echogenicity assesed by muscular ultrasound