Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
ID06765551

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

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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)
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

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

Long-term Monitoring

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

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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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