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Real-time Artificial Intelligent (AI)-Assisted Muscle Ultrasound for Monitoring Muscle Mass Reduction in ICU Patients

Real-time AI-assisted Muscle Ultrasound for Monitoring Muscle Mass Reduction in Intensive Care Unit Patients

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06034093
Acronym
RAIMUS
Enrollment
254
Registered
2023-09-13
Start date
2020-06-01
Completion date
2023-10-31
Last updated
2024-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tetanus

Keywords

Muscle Wasting, Intensive Care Unit, Muscle ultrasound, Artificial Intelligence, Deep Learning

Brief 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

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.

Interventions

DEVICEReal-time AI-assisted muscle ultrasound

RAIMUS software provides automatic segmentation and size measurement for the RFCSA

Sponsors

King's College London
CollaboratorOTHER
Oxford University Clinical Research Unit, Vietnam
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* Informed consent not given * Contraindication to ultrasound scan

Design outcomes

Primary

MeasureTime frameDescription
Reproducibility of RFCSA measurementsduring the study procedureIn 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

Secondary

MeasureTime frameDescription
Time spent on ultrasound examinationduring the study procedureIn 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

Countries

Vietnam

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026