Blood Loss Measurement Using Electrical Impedance Tomography

Blood Loss Clinical Trial

Official title:

Measurement of Blood Loss Using Electrical Impedance Tomography

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05287334
• Other study ID #: 12229
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: December 31, 2022

Study information

• Verified date: August 2022
• Source: Czech Technical University in Prague
• Contact: Vaclav Ort, M.Eng.
• Phone: +420 731 577 649
• Email: ortvacla[@]fbmi.cvut.cz
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The project focuses on the possibility of detecting blood loss using electrical impedance tomography. Based on previous animal experiments, it was found that the bolus of saline significantly affects the signal of chest bioimpedance. It is assumed that blood loss of a similar volume will cause a similar signal change with the opposite trend. The aim of this project is to determine whether there is a significant change in the thoracic electrical impedance tomography signal when blood loss is caused by voluntary blood donation.

Description:

Electrical impedance tomography is a bedside method of ventilation monitoring. The bioimpedance of the tissue depends, among other things, on its blood content. The area of the chest and especially the lungs is a heavily perfused tissue, which also serves as one of the reservoirs of blood in case of blood loss. It is therefore possible that blood loss will be visible on chest bioimpedance relatively soon.

The study will be performed on voluntary blood donors. Blood loss of 450 mL will be caused by the collection of donated blood. During blood collection at the transfusion department, thoracic bioimpedance will be measured using electrical impedance tomography. The resulting signal change will then be analyzed to determine the possibility of detecting and measuring blood loss using electrical impedance tomography.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: December 31, 2022
• Est. primary completion date: October 10, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• voluntary blood donation

Exclusion Criteria:

• standard exclusion criteria for voluntary blood donation based on the transfusion station protocol

• standard exclusion criteria for electrical impedance tomography according to the manufacturer

Related Conditions & MeSH terms

• Blood Loss
• Hemorrhage

Intervention

Device:
• Electrical impedance tomography measurement
During standard blood donation, donors' chest bioimpedance will be measured using electrical impedance tomography.

Locations

Country	Name	City	State
Czechia	Czech technical university in Prague, Facutly of biomedical engineering	Kladno
Czechia	Czech Technical University, Faculty of Biomedical Engineering	Kladno

Sponsors (2)

Lead Sponsor	Collaborator
Czech Technical University in Prague	Military University Hospital, Prague

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in chest electrical impedance due to blood loss.	A change in the electrical impedance of the chest of a voluntary blood donor caused by a blood donation.	Time frame of one voluntary blood donation process (15 min)