Actively Recruiting
Artificial IntelligenCe Based UlTrasonographic Assessment of IntensiVe CAre UniT-acquired WEakness (ACTIVATE)
Led by Jena University Hospital · Updated on 2025-01-09
50
Participants Needed
1
Research Sites
25 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
This research aims to investigate whether artificial intelligence (AI) can detect imaging features typical of Intensive Care Unit-acquired Weakness (ICUAW) using neuromuscular ultrasound. The study focuses on evaluating if AI-based image analysis can identify and monitor ICU patients with ICUAW and whether these AI results correlate with muscle weakness severity, visual muscle echogenicity grading, and 30- and 90-day patient outcomes. ICUAW is a common neuromuscular complication in critically ill patients, often difficult to assess due to patient sedation and limited cooperation during clinical exams. Participants will undergo non-invasive neuromuscular ultrasound of peripheral muscles in the upper and lower limbs. The ultrasound images will be processed using AI, specifically Convolutional Neural Networks, to classify muscle weakness severity. Explainable AI techniques will also be used to highlight the areas within the ultrasound images that contribute to the AI's decisions, helping to understand muscle changes. The study includes groups of critically ill patients with and without ICUAW as well as healthy controls. During the study, researchers will assess muscle echogenicity abnormalities by ultrasound on Day 14 and measure ICUAW severity through various scales. Additional outcomes such as ventilation duration, hospital stay length, survival, frailty, and overall recovery will be evaluated at 30 and 90 days. Data collection involves clinical examinations, scoring systems, and AI image analysis to improve diagnosis and monitoring of muscle weakness in ICU patients.
CONDITIONS
Brief 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 intensive care unit for more than 1 day after surgery
- Healthy, age-matched subjects without ICU-acquired weakness (recruited from staff of the anesthesiology and intensive care department)
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 with lasting neuromuscular impairment (e.g., cerebral hemorrhage, stroke, brain tumor)
- Receiving high-dose glucocorticoid therapy (>300 mg hydrocortisone or equivalent daily) before or during study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 14 days
Participants undergo neuromuscular ultrasound examinations of peripheral muscles with additional artificial intelligence analysis of the ultrasound images to assess muscle weakness.
Ultrasound assessments on Day 14
Duration - Up to 90 days
Participants are monitored for clinical outcomes including days on ventilation and vasopressors, hospital stay duration, survival, frailty, and global function using standardized scales.
Follow-up assessments on Days 30 and 90
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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