Blood Loss Measurement Using Electrical Impedance Tomography
Primary Purpose
Blood Loss
Status
Recruiting
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Electrical impedance tomography measurement
Sponsored by
About this trial
This is an interventional supportive care trial for Blood Loss focused on measuring Blood donation, EIT
Eligibility Criteria
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
Sites / Locations
- Czech Technical University, Faculty of Biomedical EngineeringRecruiting
- Czech technical university in Prague, Facutly of biomedical engineeringRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Voluntary blood donors
Arm Description
Voluntary blood donors undergoing standard blood donation while measuring electrical impedance of the chest .
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05287334
First Posted
March 10, 2022
Last Updated
August 8, 2022
Sponsor
Czech Technical University in Prague
Collaborators
Military University Hospital, Prague
1. Study Identification
Unique Protocol Identification Number
NCT05287334
Brief Title
Blood Loss Measurement Using Electrical Impedance Tomography
Official Title
Measurement of Blood Loss Using Electrical Impedance Tomography
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
October 10, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Czech Technical University in Prague
Collaborators
Military University Hospital, Prague
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Loss
Keywords
Blood donation, EIT
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single group assignment. Approx 10-15 voluntary blood donors.
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Voluntary blood donors
Arm Type
Experimental
Arm Description
Voluntary blood donors undergoing standard blood donation while measuring electrical impedance of the chest .
Intervention Type
Device
Intervention Name(s)
Electrical impedance tomography measurement
Intervention Description
During standard blood donation, donors' chest bioimpedance will be measured using electrical impedance tomography.
Primary Outcome Measure Information:
Title
Change in chest electrical impedance due to blood loss.
Description
A change in the electrical impedance of the chest of a voluntary blood donor caused by a blood donation.
Time Frame
Time frame of one voluntary blood donation process (15 min)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vaclav Ort, M.Eng.
Phone
+420 731 577 649
Email
ortvacla@fbmi.cvut.cz
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vaclav Ort, M.Eng.
Organizational Affiliation
Czech Technical University in Prague, Fac. of Biomedical Engineering
Official's Role
Principal Investigator
Facility Information:
Facility Name
Czech Technical University, Faculty of Biomedical Engineering
City
Kladno
ZIP/Postal Code
272 01
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karel Roubik, PhD
Phone
+420 603 479 901
Email
roubik@fbmi.cvut.cz
Facility Name
Czech technical university in Prague, Facutly of biomedical engineering
City
Kladno
ZIP/Postal Code
27201
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vaclav Ort, M.Eng
Phone
+420731577649
Email
ortvacla@fbmi.cvut.cz
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Blood Loss Measurement Using Electrical Impedance Tomography
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