Prospective Multicenter Clinical Validation of a Novel Multifunctional Intraoperative Blood Loss Monitoring System
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 120
- 试验地点
- 3
研究概览
简要总结
This observational study aims to evaluate the practicality of a novel multifunctional intraoperative blood loss monitoring system in real-world surgical settings. The primary questions it seeks to address are:
Using the direct measurement method as the reference standard, what is the magnitude of measurement error of the monitoring system, and does it tend to overestimate or underestimate blood loss? Does the monitoring system demonstrate superior accuracy compared with visual estimation, the gravimetric method, and the hemoglobin concentration-based method? During surgery, intraoperative blood loss will be measured simultaneously using five approaches: the novel multifunctional monitoring system, the direct measurement method, visual estimation, the gravimetric method, and the hemoglobin concentration method. These measurements will be conducted without interfering with the surgical procedure.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing elective urological or general surgical procedures
- •Age 18 years or older
- •Preoperative hemoglobin concentration available
- •Intraoperative blood loss assessment required during surgery
排除标准
- •Patients with incomplete intraoperative blood loss measurement data,
- •Severe hemolysis or other conditions that may affect hemoglobin measurement
- •Emergency surgery
- •Intraoperative blood loss assessment required during surgery 24 hours after surgery
- •Refusal to participate, when applicable
研究组 & 干预措施
Self-controlled
This study includes a single self-controlled cohort of patients undergoing urological and general surgical procedures. All participants will undergo simultaneous intraoperative blood loss assessment using five different methods within the same surgical procedure: a novel multifunctional intraoperative blood loss monitoring system, the direct measurement method (reference standard), visual estimation, the gravimetric method, and the hemoglobin concentration-based method.
No intervention is applied in this observational study. All measurements are performed according to a predefined protocol and do not interfere with the standard surgical workflow. The purpose of this design is to enable within-subject comparison of measurement accuracy across different methods under identical clinical conditions.
研究者
Zhiping Wang
Professor; Chief Physician
Lanzhou University Second Hospital