Actively Recruiting
Artificial Intelligence-Based Ultrasound Assessment of Muscle Weakness in Intensive Care Unit Patients (ACTIVATE)
Led by Jena University Hospital · Updated on 2025-01-09
50
Participants Needed
1
Research Sites
91 weeks
Total Duration
On this page
Sponsors
J
Jena University Hospital
Lead Sponsor
U
University of Rostock
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating whether artificial intelligence (AI) can identify ultrasound image features typical of Intensive Care Unit-Acquired Weakness (ICUAW), a common neuromuscular complication in critically ill patients. The study aims to evaluate if AI-based analysis of neuromuscular ultrasound images can detect and monitor ICUAW, and whether the AI results correlate with muscle weakness severity, visual muscle echogenicity grading, and patient outcomes at 30 and 90 days. The study uses non-invasive neuromuscular ultrasound of peripheral muscles in the upper and lower limbs, enhanced by AI processing of the images. This AI approach, specifically using Convolutional Neural Networks, classifies ultrasound images by muscle weakness level, aiming to automate and speed diagnosis. Explainable AI techniques will be applied to show which muscle areas influence the AI's decisions, improving understanding of muscle changes in ICUAW. Participants include patients aged 18 or older undergoing major elective surgery and expected to stay in the ICU for more than one day, plus healthy age-matched controls. During the study, muscle ultrasound images will be collected and analyzed, with the main outcome being the incidence of muscle echogenicity abnormalities at day 14. The study assesses AI's ability to detect ICUAW and monitors patients through clinical data, imaging, and follow-up evaluations, aiming to enhance diagnostic accuracy and patient care in intensive care settings.
CONDITIONS
Official Title
AI Based Muscular Ultrasound to Assess Intensive Care Unit-acquired Weakness
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 years or above
- Undergoing major elective surgery, such as cardiothoracic or abdominal surgery
- Expected to stay in the ICU for more than 1 day after surgery
- Healthy, age-matched individuals without ICUAW, recruited from anesthesiology and intensive care staff
You will not qualify if you...
- No informed consent provided
- Undergoing emergency surgery
- Previous participation in this study
- Preexisting neuromuscular disease
- Preexisting central nervous system disease causing neuromuscular impairment (e.g., cerebral hemorrhage, stroke, brain tumor)
- Receiving high-dose glucocorticoid therapy (more than 300 mg hydrocortisone or equivalent per day) before or during the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Department of Anesthesiology and Intensive Care Medicine, Jena University Hospital
Jena, Thuringia, Germany, 07747
Actively Recruiting
Research Team
P
PD Dr. Johannes Ehler, M.D.
D
Dr. Konstantin Schubert, M.D.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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