TetanusRAIMUSNCT06034093
Real-time Artificial Intelligent (AI)-Assisted Muscle Ultrasound for Monitoring Muscle Mass Reduction in ICU Patients
A study testing Real-time AI-assisted muscle ultrasound in people with Tetanus, run by Oxford University Clinical Research Unit, Vietnam at 1 site in Vietnam.
Trial summary
This study aims to investigate the feasibility of using a real-time artificial intelligent (AI)-assisted tool for Rectus Femoris cross sectional area measurement from muscle ultrasound to improve reliability, reduce inter- and intra-observer variability and reduce operator time spent on ultrasound examination Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Tetanus
- What is being tested?
- Real-time AI-assisted muscle ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 254 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Jun 2020to 31 Oct 2023
- Phase
- Interventional
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age ≥16 years
- Written informed consent
- Staff and equipment available for ultrasound
- Admitted to Viet Anh Ward ICU with a diagnosis of meningitis or encephalitis or Ablett Grade 3 or 4 tetanus
- Within 72 hours of ICU admission
- Duration of ICU stay expected at least 5 days
Who cannot join
- Informed consent not given
- Contraindication to ultrasound scan
Trial locations and contacts
1 site in 1 country.
Vietnam1 site
Hospital for Tropical Diseases at Ho Chi Minh city
Ho Chi Minh City, 700000
About this study
Official title: Real-time AI-assisted Muscle Ultrasound for Monitoring Muscle Mass Reduction in Intensive Care Unit Patients
This study aims to investigate the feasibility of using a real-time artificial intelligent (AI)-assisted tool for Rectus Femoris cross sectional area measurement from muscle ultrasound to improve reliability, reduce inter- and intra-observer variability and reduce operator time spent on ultrasound examination
Read the detailed description
This project proposes to develop computational methods to automatically analyze conventional 2D muscle ultrasound images in real time to assist operators circumvent achieve high quality reproducible views and measurements specifically for Rectus Femoris muscle.
Study design: This is a prospective observational study to test the reliability of AI-assisted muscle ultrasound at the patient's bedside compared to standard RFCSA ultrasound. All measurements will be performed in adult patients with severe tetanus (Ablett Grade 3 or 4) admitted to the Adult ICU at HTD expected to stay at least 5 days. All patients are on mechanical ventilation, muscle relaxation and neuromuscular blockers following the Ministry of Health guidelines.
Study procedures: Three ultrasound examinations will be carried out according to a standard operating procedure where patients are in the supine position with the leg in neutral rotation. Measurements will be taken using 12L-RS linear probe, Venue Go ultrasound machine (General Electric Healthcare, London, UK).
Statistical analysis: Study will compare the intra- and interobserver variability of measurements and examination duration. All statistical analysis was performed with R version 4.0.4.
- Conditions
- Tetanus
- Being tested
- Real-time AI-assisted muscle ultrasound
- Keywords
- Muscle Wasting, Intensive Care Unit, Muscle ultrasound, Artificial Intelligence, Deep Learning
- Medical subject headings
- Tetanus, Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real-time AI-assisted muscle ultrasoundDevice
RAIMUS software provides automatic segmentation and size measurement for the RFCSA
| Study group | Role | What they receive |
|---|---|---|
| Real-time AI-assisted muscle ultrasound | Experimental | RAIMUS software provides automatic segmentation and size measurement for the RFCSA Receives: Device: Real-time AI-assisted muscle ultrasound |
| Manual muscle ultrasound | No intervention | Manual segmentation and size measurement for the RFCSA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reproducibility of RFCSA measurements
In this trial, the users are randomly assigned to scan muscle ultrasound with and without AI-assisted software to measure the size of the Rectus Femoris muscle. The investigators will compare the reliability and agreement metrics of the RF measurement
Measured: during the study procedure
Secondary outcomes (1)
Time spent on ultrasound examination
In this trial, the users are randomly assigned to scan muscle ultrasound with and without AI-assisted software to measure the size of the Rectus Femoris muscle. The investigators will record the time needed to carry out the muscle ultrasound examinations
Measured: during the study procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start1 Jun 2020
- Primary completion10 Aug 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TetanusStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The developed AI assistant, named RAIMUS, was deployed in real-time using the PRETUS tool. The ultrasound machine HDMI output was connected to the laptop via a USB framegrabber. This allowed the user to use an external screen with an AI overlay instead of the screen of the ultrasound machine. The interface to RAIMUS is as follows. On the right of the screen, there is a widget containing information from the automatic muscle segmentation, including the muscle delineation continuously overlaid onto the ultrasound image and the corresponding cross-sectional area in cm2. The segmentation overlay and related information can be enabled or disabled by the user.
- Masking
- None (open label)
- Enrolment
- 254 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oxford University Clinical Research Unit, Vietnam
- Sponsor type
- University, hospital or other
- Collaborators
- King's College London
- Responsible party
- Sponsor
- Investigators
- Sophie Yacoub, PhD, Principal investigator, Oxford University Clinical Research Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06034093
- Sponsor's protocol ID
- 01NVb
- Other IDs
- OxTREC 516-20
- Acronym
- RAIMUS
- Status last verified
- Mar 2024
- First submitted
- 30 Aug 2023
- Last updated
- 20 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-time AI-assisted Muscle Ultrasound for Monitoring Muscle Mass Reduction in Intensive Care Unit Patients
- ClinicalTrials.gov ID
- NCT06034093
- Acronym / sponsor ID
- RAIMUS / 01NVb
- Conditions
- Tetanus
- Keywords
- Muscle Wasting, Intensive Care Unit, Muscle ultrasound, Artificial Intelligence, Deep Learning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 254 participants (actual)
- Lead sponsor
- Oxford University Clinical Research Unit, VietnamUniversity, hospital or other
- Collaborators
- King's College London
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 10 Aug 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 13 Sep 2023 (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.
This study aims to investigate the feasibility of using a real-time artificial intelligent (AI)-assisted tool for Rectus Femoris cross sectional area measurement from muscle ultrasound to improve reliability, reduce inter- and intra-observer variability and reduce operator time spent on ultrasound examination
Detailed description
This project proposes to develop computational methods to automatically analyze conventional 2D muscle ultrasound images in real time to assist operators circumvent achieve high quality reproducible views and measurements specifically for Rectus Femoris muscle.
Study design: This is a prospective observational study to test the reliability of AI-assisted muscle ultrasound at the patient's bedside compared to standard RFCSA ultrasound. All measurements will be performed in adult patients with severe tetanus (Ablett Grade 3 or 4) admitted to the Adult ICU at HTD expected to stay at least 5 days. All patients are on mechanical ventilation, muscle relaxation and neuromuscular blockers following the Ministry of Health guidelines.
Study procedures: Three ultrasound examinations will be carried out according to a standard operating procedure where patients are in the supine position with the leg in neutral rotation. Measurements will be taken using 12L-RS linear probe, Venue Go ultrasound machine (General Electric Healthcare, London, UK).
Statistical analysis: Study will compare the intra- and interobserver variability of measurements and examination duration. All statistical analysis was performed with R version 4.0.4.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The developed AI assistant, named RAIMUS, was deployed in real-time using the PRETUS tool. The ultrasound machine HDMI output was connected to the laptop via a USB framegrabber. This allowed the user to use an external screen with an AI overlay instead of the screen of the ultrasound machine. The interface to RAIMUS is as follows. On the right of the screen, there is a widget containing information from the automatic muscle segmentation, including the muscle delineation continuously overlaid onto the ultrasound image and the corresponding cross-sectional area in cm2. The segmentation overlay and related information can be enabled or disabled by the user.
| Arm | Type | Receives |
|---|---|---|
| Real-time AI-assisted muscle ultrasound | Experimental | Device: Real-time AI-assisted muscle ultrasoundRAIMUS software provides automatic segmentation and size measurement for the RFCSA |
| Manual muscle ultrasound | No intervention | –Manual segmentation and size measurement for the RFCSA |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥16 years
- Written informed consent
- Staff and equipment available for ultrasound
- Admitted to Viet Anh Ward ICU with a diagnosis of meningitis or encephalitis or Ablett Grade 3 or 4 tetanus
- Within 72 hours of ICU admission
Key exclusion criteria (2 listed)
- Informed consent not given
- Contraindication to ultrasound scan
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 |
|---|---|---|
| Real-time AI-assisted muscle ultrasoundRAIMUS software provides automatic segmentation and size measurement for the RFCSA | Device | Real-time AI-assisted muscle ultrasound |
Primary outcome
Reproducibility of RFCSA measurements
Time frame: during the study procedure
In this trial, the users are randomly assigned to scan muscle ultrasound with and without AI-assisted software to measure the size of the Rectus Femoris muscle. The investigators will compare the reliability and agreement metrics of the RF measurement
1 secondary outcome
Time spent on ultrasound examination
Time frame: during the study procedure
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 20 Mar 2024.
- Individual participant dataSharing planned: No
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Diptheria Immunization, Tetanus Immunization
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.
Sophie Yacoub, PhD principal investigator
Oxford University Clinical Research Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Real-time AI-assisted muscle ultrasound in people with Tetanus, run by Oxford University Clinical Research Unit, Vietnam at 1 site in Vietnam.
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 6 inclusion and 2 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 20 Mar 2024. 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 Vietnam. 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?
Reproducibility of RFCSA measurements (time frame: during the study procedure). 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 20 Mar 2024.