Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-27 @ 11:41 PM
Study NCT ID:
NCT06034093
Status:
COMPLETED
Last Update Posted:
2024-03-20
First Post:
2023-08-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Real-time Artificial Intelligent (AI)-Assisted Muscle Ultrasound for Monitoring Muscle Mass Reduction in ICU Patients
Sponsor:
Oxford University Clinical Research Unit, Vietnam
Organization:
Study Overview
Official Title:
Real-time AI-assisted Muscle Ultrasound for Monitoring Muscle Mass Reduction in Intensive Care Unit Patients
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RAIMUS
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 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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| OxTREC 516-20 | OTHER | Oxford | View |