ClinicalTrials.gg
CompletedNCT06765551ACTIVATEUpdated Aug 18, 2026

AI Based Muscular Ultrasound to Assess Intensive Care Unit-acquired Weakness

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.

Primary conditionAsthenia(the registry's first term)UnverifiedIs this wrong?Asthenia is a broad heading, used only when no more specific condition is named. No better condition is named, so the registry's term is kept.

Sponsored by Jena University Hospital · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
64
Ages
18 Years and older
Sex
All
01

Study 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?

Read the detailed description

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.

02

Conditions studied

  • Intensive Care Unit-acquired Weakness
  • Artifical Intelligence
  • Ultrasound

Browse trials for

Keywords

  • weakness
  • neuromuscular
  • critical illness polyneuropathy
  • critical illness myopathy
  • neuromuscular impairment
03

In context

Asthenia Unverified

77 studies on the registry are indexed under Asthenia; 16 are open to participants now.

This study's enrollment of 64 is below the median of 113 across 13 observational studies indexed under Asthenia.

Browse Asthenia studies →

Lead sponsor

Jena University Hospital is the lead sponsor of 64 studies on the registry; 20 are open to participants now.

Compared within Asthenia, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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.

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

Exclusion Criteria:

  • No
  • 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 therapy (>300 mg hydrocortisone or equivalent per day) before or during particiation in the study
Terms in these criteria, in plain language(2)

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.

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.

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.

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
64 participants (actual)
Patient registry
No

Groups and cohorts

  • Patients with ICUAW (ICUAW+)

    Critically ill patients with ICUAW.

    Diagnostic Test: Neuromuscular Ultrasound

  • Patients without ICUAW (ICUAW-)

    Critically ill patients without ICUAW.

    Diagnostic Test: Neuromuscular Ultrasound

  • Healthy controls without ICUAW (ICUAW-)

    Diagnostic Test: Neuromuscular Ultrasound

Interventions

  • Diagnostic testNeuromuscular Ultrasound

    Non-invasive ultrasound of peripheral muscles of the upper and lower extremities with additional artificiall intelligence processing of ultrasound images.

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. Incidence of ICUAW severity assessed by Heckmatt Scale

    Time frame: Day 14

  2. Incidence of ICUAW severity assessed by Medical Research Council Sum Score

    Time frame: Day 14

  3. Days on ventilation

    Time frame: Day 30

  4. Days on vasopressors

    Time frame: Day 30

  5. Number of days in Hospital

    Time frame: Day 30

  6. Number of patients with survival

    Time frame: Day 30

  7. Frailty assessed by FRAIL-Scale

    Time frame: Day 30

  8. Global outcome assessed by Bathel Index

    Time frame: Day 30

  9. Number of patients with survival

    Time frame: Day 90

  10. Frailty assessed by FRAIL-Scale

    Time frame: Day 90

  11. Global outcome assessed by Bathel Index

    Time frame: Day 90

07

Study locations

1 site
  • Department of Anesthesiology and Intensive Care Medicine, Jena University Hospital
    Jena, Thuringia 07747, Germany
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06765551
Lead sponsor
Jena University Hospital
Collaborators
University of Rostock
Responsible party
Johannes Ehler (Principal Investigator, Jena University Hospital) — Principal investigator
First posted
Jan 9, 2025
Start date
Oct 1, 2024
Primary completion
Jul 31, 2026
Completion
Jul 31, 2026
Last update
Aug 18, 2026

Study contacts

PD Dr. Johannes Ehler, M.D.
principal investigator · Department of Anesthesiology and Intensive Care Medicine, Jena University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion