An observational study in Intensive Care Unit-acquired Weakness, Artifical Intelligence and Ultrasound, sponsored by Jena University Hospital. Completed at 1 site in Germany. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-18.
Sponsored by Jena University Hospital · Observational
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:
(A) the severity of ICUAW (B) the visual grading of muscle echogenicity (C) the 30- and 90-day-outcome?
Intensive Care Unit-Acquired Weakness (ICUAW) is one of the most common neuromuscular complications in patients treated in intensive care. With increasing disease severity and especially in analgosedated, ventilated and delirious patients with limited ability to cooperate during the clinical examination, the detection and follow-up of ICUAW is limited to impossible. The clinical diagnosis and severity assessment of ICUAW is usually carried out with the help of established diagnostic methods (e.g. clinical-neurological examination, Medical Research Council-Sum Score, electrophysiological examinations), which, however, cannot be carried out regularly if the patient does not cooperate, thus delaying the diagnosis of ICUAW and making follow-up more difficult. Neuromuscular ultrasound (NMUS), on the other hand, is an easy-to-use, non-invasive examination option that is largely independent of patient compliance and is increasingly being investigated in patients with ICUAW. It was shown that NMUS can detect ICUAW and is helpful in assessing the severity of muscular weakness. However, the standardized recording and follow-up by means of scoring procedures (e.g. the 4-stage Heckmatt Scala) is assessed as partially subjective by the examiner and each individual ultrasound image must be taken with the human eye, taking into account various image parameters. To overcome these diagnostic limitations, artificial intelligence (AI) could be a useful extension or even an alternative.
AI is already being used in a variety of ways in medical diagnostics (e.g. in the detection of tumors and organ assessment), and increasingly also in the analysis of ultrasound images. In this study, the investigators aim to use AI, specifically Convolutional Neural Networks (CNNs), to classify ultrasound images into different categories based on muscle weakness. The main benefit of using AI for such tasks lies in the automation it provides. Once an AI model has been trained on an initial set of images, it can quickly categorize new, unseen images, significantly reducing the time and human effort required for diagnosis. AI models can analyze large amounts of data quickly and consistently, which is especially beneficial in a clinical intensive care setting. By applying AI, this study aims to train the detection and classification of muscle weakness in patients treated in intensive care. However, one challenge with AI models is their "black box" nature, where the decision-making process is not transparent. To solve this problem, the investigators will use explainable AI techniques (XAI) such as Grad-CAM (Gradient-weighted Class Activation Mapping) to visualize the specific areas of the ultrasound images that the AI model focuses on in its analysis. This not only helps validate the AI decisions, but also provides insights into the morphological changes in the muscles that come with different degrees of weakness.
By integrating AI and XAI, the study team aims to not only automate the detection and categorization of muscle weakness, but also improve our understanding of the underlying morphological changes in muscles. This dual approach could lead to more accurate and reliable diagnostics and ultimately improve outcomes for patients in intensive care.
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All patients with critical illness fulfilling the inclusion criteria should be screened for the study on two surgical ICUs at the department of anesthesiology and intensive care medicine of Jena University Hospital, Germany.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Critically ill patients with ICUAW.
Diagnostic Test: Neuromuscular Ultrasound
Critically ill patients without ICUAW.
Diagnostic Test: Neuromuscular Ultrasound
Diagnostic Test: Neuromuscular Ultrasound
Non-invasive ultrasound of peripheral muscles of the upper and lower extremities with additional artificiall intelligence processing of ultrasound images.
Incidence of abnormalities of muscle echogenicity assesed by muscular ultrasound
Determination of the number of patients correctly classified as ICUAW (+) using AI-based ultrasound evaluation
Time frame: Day 14
Incidence of ICUAW severity assessed by Heckmatt Scale
Time frame: Day 14
Incidence of ICUAW severity assessed by Medical Research Council Sum Score
Time frame: Day 14
Days on ventilation
Time frame: Day 30
Days on vasopressors
Time frame: Day 30
Number of days in Hospital
Time frame: Day 30
Number of patients with survival
Time frame: Day 30
Frailty assessed by FRAIL-Scale
Time frame: Day 30
Global outcome assessed by Bathel Index
Time frame: Day 30
Number of patients with survival
Time frame: Day 90
Frailty assessed by FRAIL-Scale
Time frame: Day 90
Global outcome assessed by Bathel Index
Time frame: Day 90
Plan to share: No
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This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Jena University Hospital