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Clinical Validation of a Blood Loss Monitoring System

18 juni 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Aanmelden op uitnodiging

Conditie

Intraoperatief bloedverlies

Studietype

Observationeel

Inschrijving (Geschat)

120

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

China
- Gansu
  - Lanzhou, Gansu, China, 730030
    - Lanzhou University Second Hospital
  - Lanzhou, Gansu, China, 730030
    - Lanzhou University Frist Hospital
  - Lanzhou, Gansu, China, 730030
    - Gansu Provincial People's Hospital

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

Volwassen
Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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.

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Aantal groepen / cohorten

Cohorten en interventies

Groep / Cohort
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.

Groep / Cohort

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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Absolute error of the automatic intraoperative blood loss monitor compared with the direct measurement method Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Percentage error of the automatic intraoperative blood loss monitor compared with the direct measurement method Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Lanzhou University Second Hospital

Medewerkers

Lanzhou University First Hospital

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

10 september 2025

Primaire voltooiing (Geschat)

30 juni 2026

Studie voltooiing (Geschat)

30 juni 2026

Studieregistratiedata

Eerst ingediend

5 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

23 mei 2026

Eerst geplaatst (Werkelijk)

1 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

23 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

18 juni 2026

Laatst geverifieerd

1 april 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

2025A-987

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

ONBESLIST

Beschrijving IPD-plan

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.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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