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Intensive Care Unit-acquired WeaknessACTIVATENCT06765551

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

An observational study of Intensive Care Unit-acquired Weakness and Artifical Intelligence, run by Jena University Hospital at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Neuromuscular Ultrasound
How many people
64 participants
Where
1 siteGermany
Study dates
1 Oct 2024to 31 Jul 2026
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

  • 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)

Who cannot join

  • No informed consent
  • 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 glucocorticoid therapy (>300 mg hydrocortisone or equivalent per day) before or during particiation in the study

Trial locations and contacts

1 site in 1 country.

Germany1 site
  • Department of Anesthesiology and Intensive Care Medicine, Jena University Hospital

    Jena, Thuringia, 07747

Other trials in Germany

About this study

Official title: Artificial intelligenCe Based ulTrasonographic Assessment of IntensiVe cAre uniT-acquired wEakness (ACTIVATE)

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.

Being tested
Neuromuscular Ultrasound
Keywords
weakness, neuromuscular, critical illness polyneuropathy, critical illness myopathy, neuromuscular impairment
Medical subject headings
Asthenia, Polyneuropathies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Neuromuscular UltrasoundDiagnostic test

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

Study groups in NCT06765551
Study groupRoleWhat they receive
Patients with ICUAW (ICUAW+)Critically ill patients with ICUAW.
Receives: Diagnostic Test: Neuromuscular Ultrasound
Patients without ICUAW (ICUAW-)Critically ill patients without ICUAW.
Receives: Diagnostic Test: Neuromuscular Ultrasound
Healthy controls without ICUAW (ICUAW-)Not described
Receives: Diagnostic Test: Neuromuscular Ultrasound

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Day 14

Secondary outcomes (11)
  1. Incidence of ICUAW severity assessed by Heckmatt Scale

    Measured: Day 14

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

    Measured: Day 14

  3. Days on ventilation

    Measured: Day 30

  4. Days on vasopressors

    Measured: Day 30

  5. Number of days in Hospital

    Measured: Day 30

  6. Number of patients with survival

    Measured: Day 30

  7. Frailty assessed by FRAIL-Scale

    Measured: Day 30

  8. Global outcome assessed by Bathel Index

    Measured: Day 30

  9. Number of patients with survival

    Measured: Day 90

  10. Frailty assessed by FRAIL-Scale

    Measured: Day 90

  11. Global outcome assessed by Bathel Index

    Measured: Day 90

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jan 2025
  2. Study start1 Oct 2024
  3. Primary completion31 Jul 2026
  4. Study completion31 Jul 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06765551
Sponsor's protocol ID
2024-3434-BO
Acronym
ACTIVATE
Status last verified
Aug 2026
First submitted
27 Dec 2024
Last updated
18 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Intensive Care Unit-acquired Weakness and Artifical Intelligence, run by Jena University Hospital at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of abnormalities of muscle echogenicity assesed by muscular ultrasound (time frame: Day 14). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.

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