Clinical Validation of a Blood Loss Monitoring System
Prospective Multicenter Clinical Validation of a Novel Multifunctional Intraoperative Blood Loss Monitoring System
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.
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Ubicaciones de estudio
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Gansu
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Lanzhou, Gansu, Porcelana, 730030
- Lanzhou University Second Hospital
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Lanzhou, Gansu, Porcelana, 730030
- Lanzhou University Frist Hospital
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Lanzhou, Gansu, Porcelana, 730030
- Gansu Provincial People's Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Patients undergoing elective urological or general surgical procedures
- Age 18 years or older
- Preoperative hemoglobin concentration available
- Intraoperative blood loss assessment required during surgery
Exclusion Criteria:
- 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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Absolute error of the automatic intraoperative blood loss monitor compared with the direct measurement method
Periodo de tiempo: At the end of surgery
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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) |
At the end of surgery
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Percentage error of the automatic intraoperative blood loss monitor compared with the direct measurement method
Periodo de tiempo: At the end of surgery
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Percentage error is defined as the relative difference between intraoperative blood loss measured by the automatic intraoperative blood loss monitor and intraoperative blood loss measured by the direct measurement method, expressed as a percentage of the average value obtained by the two methods. A positive value indicates overestimation by the monitor, whereas a negative value indicates underestimation. Unit of Measure: Percentage |
At the end of surgery
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Absolute error of visual estimation compared with the direct measurement method
Periodo de tiempo: At the end of surgery
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Absolute error is defined as the numerical difference between intraoperative blood loss estimated by visual estimation and intraoperative blood loss measured by the direct measurement method. A positive value indicates overestimation by visual estimation, whereas a negative value indicates underestimation. Unit of Measure: Milliliters |
At the end of surgery
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Absolute error of the gravimetric method compared with the direct measurement method
Periodo de tiempo: At the end of surgery
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The accuracy of five methods (monitoring system, direct measurement, visual Absolute error is defined as the numerical difference between intraoperative blood loss estimated by the gravimetric method and intraoperative blood loss measured by the direct measurement method. A positive value indicates overestimation by the gravimetric method, whereas a negative value indicates underestimation. Unit of Measure: Milliliters |
At the end of surgery
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Absolute error of the hemoglobin concentration-based method compared with the direct measurement method
Periodo de tiempo: 24 hours after surgery
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Absolute error is defined as the numerical difference between blood loss estimated by the hemoglobin concentration-based method and intraoperative blood loss measured by the direct measurement method. The hemoglobin concentration-based estimate is calculated using preoperative hemoglobin concentration, hemoglobin concentration measured 24 hours after surgery, and estimated blood volume. A positive value indicates overestimation by the hemoglobin concentration-based method, whereas a negative value indicates underestimation. Unit of Measure: Milliliters |
24 hours after surgery
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Intraclass correlation coefficient between the automatic intraoperative blood loss monitor and the direct measurement method
Periodo de tiempo: At the end of surgery
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The intraclass correlation coefficient is used to quantify agreement between intraoperative blood loss measured by the automatic intraoperative blood loss monitor and intraoperative blood loss measured by the direct measurement method. Higher values indicate stronger agreement between the two methods. Unit of Measure: Unitless coefficient |
At the end of surgery
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Bland-Altman mean bias between the automatic intraoperative blood loss monitor and the direct measurement method
Periodo de tiempo: Unit of Measure: Milliliters
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Bland-Altman mean bias is defined as the mean 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 mean bias indicates systematic overestimation by the monitor, whereas a negative mean bias indicates systematic underestimation.
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Unit of Measure: Milliliters
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Bland-Altman limits of agreement between the automatic intraoperative blood loss monitor and the direct measurement method
Periodo de tiempo: At the end of surgery
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Bland-Altman limits of agreement describe the range within which most differences between intraoperative blood loss measured by the automatic intraoperative blood loss monitor and intraoperative blood loss measured by the direct measurement method are expected to fall. Unit of Measure: Milliliters |
At the end of surgery
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2025A-987
Plan de datos de participantes individuales (IPD)
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Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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