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.
Visão geral do estudo
Status
Condições
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Locais de estudo
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Gansu
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Lanzhou, Gansu, China, 730030
- Lanzhou University Second Hospital
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Lanzhou, Gansu, China, 730030
- Lanzhou University Frist Hospital
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Lanzhou, Gansu, China, 730030
- Gansu Provincial People's Hospital
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Método de amostragem
População do estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
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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. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Absolute error of the automatic intraoperative blood loss monitor compared with the direct measurement method
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Percentage error of the automatic intraoperative blood loss monitor compared with the direct measurement method
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2025A-987
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Informações sobre medicamentos e dispositivos, documentos de estudo
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