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

Not Applicable

Completed

• Conditions: Tetanus
• Interventions: Device: Real-time AI-assisted muscle ultrasound

• Registration Number: NCT06034093
• Lead Sponsor: Oxford University Clinical Research Unit, Vietnam

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.

Study Timeline

• Study Start: 2020-06-01
• Primary Completion: 2023-08-10
• Study First Submitted: 2023-08-30
• Study First Submitted QC: 2023-09-10
• Study First Posted: 2023-09-13
• Study Completion: 2023-10-31
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-19
• Last Update Posted: 2024-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 254

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Real-time AI-assisted muscle ultrasound	Real-time AI-assisted muscle ultrasound	RAIMUS software provides automatic segmentation and size measurement for the RFCSA

Primary Outcome Measures

Name	Time	Method
Reproducibility of RFCSA measurements	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 Outcome Measures

Name	Time	Method
Time spent on ultrasound examination	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

Trial Locations

Locations (1)

Hospital for Tropical Diseases at Ho Chi Minh city; 🇻🇳 Ho Chi Minh City, Vietnam