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Completed

NCT Number: NCT06034093

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

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Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital for Tropical Diseases at Ho Chi Minh city

Ho Chi Minh City, 700000, Vietnam

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Real-time AI-assisted muscle ultrasound

Device

RAIMUS software provides automatic segmentation and size measurement for the RFCSA

Primary outcomes

  1. 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

Secondary outcomes

  1. Time spent on ultrasound examination

    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 record the time needed to carry out the muscle ultrasound examinations

Sponsors and collaborators

Lead sponsor

Oxford University Clinical Research Unit, Vietnam

Other

Collaborators

  • King's College London

Registry information

Official study title

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

Acronym: RAIMUS

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Sep 13, 2023
Registry last updated
Mar 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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