Blood Loss Evaluation Using a Novel Device

Blood Loss, Surgical Clinical Trial

Official title:

Quantification of Blood Loss Using a Novel Device in Comparison to Visually Estimated Blood Loss in a Simulated Blood Loss Scenario

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04245995
• Other study ID #: KGU_FP_2020_CA1
• Status: Completed
• Start date: February 5, 2020
• Est. completion date: February 21, 2020

Study information

• Verified date: February 2020
• Source: Johann Wolfgang Goethe University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: February 21, 2020
• Est. primary completion date: February 21, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Health care professionals

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Blood Loss, Surgical
• Hemorrhage
• Patient Blood Management
• Transfusion

Intervention

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.

Locations

Country	Name	City	State
Germany	Department of Anaesthesiology, Intensive Care Medicine and Pain Therapy, University Hospital Frankfurt, Goethe University	Frankfurt	NRW

Sponsors (1)

Lead Sponsor	Collaborator
Johann Wolfgang Goethe University Hospital

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Estimated blood loss	Visual versus novel device estimated blood loss	02.05.2020 - 03.15.2020