Clinical Validation of a Blood Loss Monitoring System

Condition(s) studied

Study summary

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.

Eligibility

Primary outcome measure(s)

• Absolute error of the automatic intraoperative blood loss monitor compared with the direct measurement method — At the end of surgery
  Absolute error is defined as the numerical difference between intraoperative blood loss measured by the automatic intraoperative blood loss monitor and intraoperative blood loss measured by the direct measurement method. A positive value indicates that the monitor overestimates blood loss compared with the direct measurement method, whereas a negative value indicates underestimation. Unit of Measure: Milliliters (mL)

Trial sites (3)

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