Blood Loss Evaluation Using a Novel Device

Overview

The study´s aim is to evaluate the clinical applicability of the Feature Extraction Technology (FET) during a simulated blood loss scenario.

Full Title of Study: “Quantification of Blood Loss Using a Novel Device in Comparison to Visually Estimated Blood Loss in a Simulated Blood Loss Scenario”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: February 21, 2020

Detailed Description

In an operating theatre blood loss will be simulated in different scenarios. Expired whole blood donations (provided by the German Red Cross, Institute of Transfusions Medicine, Goethe University Frankfurt) will be used. Blood will be diluted by full electrolyte solutions . Sponges and canisters will be prepared with a predetermined amount of blood. Study participants will estimate total blood loss on sponges and canisters. Study members not knowing the correct amount of prepared blood will measure the blood loss in sponges and canisters by Feature Extraction Technology (FET) and by gravimetric method before and after estimation of the participants.

Interventions

  • Diagnostic Test: Feature Extraction Technology
    • The study´s aim was evaluation of the clinical applicability of the Feature Extraction Technology (FET) during a simulated blood loss scenario in comparison to visual estimation.

Clinical Trial Outcome Measures

Primary Measures

  • Estimated blood loss
    • Time Frame: 02.05.2020 – 03.15.2020
    • Visual versus novel device estimated blood loss

Participating in This Clinical Trial

Inclusion Criteria

  • Health care professionals Exclusion Criteria:

  • None

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Johann Wolfgang Goethe University Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Dr. Florian Piekarski, Principal Investigator – Johann Wolfgang Goethe University Hospital
  • Overall Official(s)
    • Florian Piekarski, Dr. med., Principal Investigator, Goethe University, Frankfurt, Germany.

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