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.
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
- Conditions the study is for
- Intensive Care Unit-acquired Weakness, Artifical Intelligence, Ultrasound
- 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
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:
- 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?
- 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 group | Role | What 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.
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)
Incidence of ICUAW severity assessed by Heckmatt Scale
Measured: Day 14
Incidence of ICUAW severity assessed by Medical Research Council Sum Score
Measured: Day 14
Days on ventilation
Measured: Day 30
Days on vasopressors
Measured: Day 30
Number of days in Hospital
Measured: Day 30
Number of patients with survival
Measured: Day 30
Frailty assessed by FRAIL-Scale
Measured: Day 30
Global outcome assessed by Bathel Index
Measured: Day 30
Number of patients with survival
Measured: Day 90
Frailty assessed by FRAIL-Scale
Measured: Day 90
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.
- First posted9 Jan 2025
- Study start1 Oct 2024
- Primary completion31 Jul 2026
- Study completion31 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intensive Care Unit-acquired WeaknessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Jena University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Rostock
- Responsible party
- Principal investigator, Johannes Ehler, Jena University Hospital
- Investigators
- PD Dr. Johannes Ehler, M.D., Principal investigator, Department of Anesthesiology and Intensive Care Medicine, Jena University Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial intelligenCe Based ulTrasonographic Assessment of IntensiVe cAre uniT-acquired wEakness (ACTIVATE)
- ClinicalTrials.gov ID
- NCT06765551
- Acronym / sponsor ID
- ACTIVATE / 2024-3434-BO
- Keywords
- weakness, neuromuscular, critical illness polyneuropathy, critical illness myopathy, neuromuscular impairment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Jena University HospitalUniversity, hospital or other
- Collaborators
- University of Rostock
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 31 Jul 2026 (actual)
- Study completion
- 31 Jul 2026 (actual)
- First posted
- 9 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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?
- 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?
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with ICUAW (ICUAW+) | – | Diagnostic Test: Neuromuscular UltrasoundCritically ill patients with ICUAW. |
| Patients without ICUAW (ICUAW-) | – | Diagnostic Test: Neuromuscular UltrasoundCritically ill patients without ICUAW. |
| Healthy controls without ICUAW (ICUAW-) | – | Diagnostic Test: Neuromuscular Ultrasound |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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.
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuromuscular UltrasoundNon-invasive ultrasound of peripheral muscles of the upper and lower extremities with additional artificiall intelligence processing of ultrasound images. | Diagnostic test | Healthy controls without ICUAW (ICUAW-), Patients with ICUAW (ICUAW+), Patients without ICUAW (ICUAW-) |
Primary outcome
Incidence of abnormalities of muscle echogenicity assesed by muscular ultrasound
Time frame: Day 14
Determination of the number of patients correctly classified as ICUAW (+) using AI-based ultrasound evaluation
11 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
PD Dr. Johannes Ehler, M.D. principal investigator
Department of Anesthesiology and Intensive Care Medicine, Jena University Hospital
1 site in 1 country: see every site and its status.
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.