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Clinical Validation of a Blood Loss Monitoring System

31. Mai 2026 aktualisiert von: 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.

Studienübersicht

Status

Anmeldung auf Einladung

Bedingungen

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

120

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • 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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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.

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Absolute error of the automatic intraoperative blood loss monitor compared with the direct measurement method
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Percentage error of the automatic intraoperative blood loss monitor compared with the direct measurement method
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Lanzhou University Second Hospital

Mitarbeiter

Lanzhou University First Hospital

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

10. September 2025

Primärer Abschluss (Geschätzt)

30. Mai 2026

Studienabschluss (Geschätzt)

30. Mai 2026

Studienanmeldedaten

Zuerst eingereicht

5. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

23. Mai 2026

Zuerst gepostet (Tatsächlich)

1. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

3. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

31. Mai 2026

Zuletzt verifiziert

1. April 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 2025A-987

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

UNENTSCHIEDEN

Beschreibung des IPD-Plans

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.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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