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Clinical Validation of a Blood Loss Monitoring System

31. maj 2026 opdateret af: Zhiping Wang, Lanzhou University Second Hospital

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.

Studieoversigt

Status

Tilmelding efter invitation

Betingelser

Undersøgelsestype

Observationel

Tilmelding (Anslået)

120

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Kina
    • Gansu
      • Lanzhou, Gansu, Kina, 730030
        • Lanzhou University Second Hospital
      • Lanzhou, Gansu, Kina, 730030
        • Lanzhou University Frist Hospital
      • Lanzhou, Gansu, Kina, 730030
        • Gansu Provincial People's Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

The study population will be recruited from adult patients undergoing elective urological and general surgical procedures at two tertiary hospitals in China, including Lanzhou University Second Hospital and Lanzhou University First Hospital. Participants will be selected from routine clinical practice settings where intraoperative blood loss monitoring is required. This population represents adult surgical patients managed under standard perioperative care, providing a real-world clinical context for evaluating intraoperative blood loss measurement methods.

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Absolute error of the automatic intraoperative blood loss monitor compared with the direct measurement method
Tidsramme: 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)
At the end of surgery

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage error of the automatic intraoperative blood loss monitor compared with the direct measurement method
Tidsramme: At the end of surgery

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
Absolute error of visual estimation compared with the direct measurement method
Tidsramme: At the end of surgery

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
Absolute error of the gravimetric method compared with the direct measurement method
Tidsramme: At the end of surgery

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
Absolute error of the hemoglobin concentration-based method compared with the direct measurement method
Tidsramme: 24 hours after surgery

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
Intraclass correlation coefficient between the automatic intraoperative blood loss monitor and the direct measurement method
Tidsramme: At the end of surgery

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
Bland-Altman mean bias between the automatic intraoperative blood loss monitor and the direct measurement method
Tidsramme: Unit of Measure: Milliliters
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.
Unit of Measure: Milliliters
Bland-Altman limits of agreement between the automatic intraoperative blood loss monitor and the direct measurement method
Tidsramme: At the end of surgery

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Lanzhou University Second Hospital

Samarbejdspartnere

Lanzhou University First Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

10. september 2025

Primær færdiggørelse (Anslået)

30. maj 2026

Studieafslutning (Anslået)

30. maj 2026

Datoer for studieregistrering

Først indsendt

5. maj 2026

Først indsendt, der opfyldte QC-kriterier

23. maj 2026

Først opslået (Faktiske)

1. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

3. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

31. maj 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2025A-987

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

IPD-planbeskrivelse

The clinical data involves sensitive patient privacy. We are currently undecided on sharing the IPD, as it requires specific informed consent from the patients and authorization from the hospital's ethics committee.

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