Real-time AI-assisted Muscle Ultrasound for Monitoring Muscle Mass Reduction in Intensive Care Unit Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 254
- 试验地点
- 2
- 主要终点
- Reproducibility of RFCSA measurements
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Informed consent not given
- •Contraindication to ultrasound scan
结局指标
主要结局
Reproducibility of RFCSA measurements
时间窗: 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
次要结局
- Time spent on ultrasound examination(during the study procedure)