Blood LossNCT05287334
Blood Loss Measurement Using Electrical Impedance Tomography
A study testing Electrical impedance tomography measurement in people with Blood Loss, run by Czech Technical University in Prague at 2 sites in Czechia.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Blood Loss
- What is being tested?
- Electrical impedance tomography measurement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesCzechia
- Study dates
- 1 Jul 2022to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- voluntary blood donation
Who cannot join
- standard exclusion criteria for voluntary blood donation based on the transfusion station protocol
- standard exclusion criteria for electrical impedance tomography according to the manufacturer
Trial locations and contacts
2 sites in 1 country.
Czechia2 sites, 2 recruiting
- Recruiting
Czech Technical University, Faculty of Biomedical Engineering
Kladno, 272 01
Karel Roubik, PhD, +420 603 479 901, roubik@fbmi.cvut.cz
- Recruiting
Czech technical university in Prague, Facutly of biomedical engineering
Kladno, 27201
Vaclav Ort, M.Eng, +420731577649, ortvacla@fbmi.cvut.cz
About this study
Official title: Measurement of Blood Loss Using Electrical Impedance Tomography
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.
Read the 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.
- Conditions
- Blood Loss
- Being tested
- Electrical impedance tomography measurement
- Keywords
- Blood donation, EIT
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrical impedance tomography measurementDevice
During standard blood donation, donors' chest bioimpedance will be measured using electrical impedance tomography.
| Study group | Role | What they receive |
|---|---|---|
| Voluntary blood donors | Experimental | Voluntary blood donors undergoing standard blood donation while measuring electrical impedance of the chest . Receives: Device: Electrical impedance tomography measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Time frame of one voluntary blood donation process (15 min)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2022
- Study start1 Jul 2022
- Primary completion10 Oct 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single group assignment. Approx 10-15 voluntary blood donors.
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Czech Technical University in Prague
- Sponsor type
- University, hospital or other
- Collaborators
- Military University Hospital, Prague
- Responsible party
- Sponsor
- Investigators
- Vaclav Ort, M.Eng., Principal investigator, Czech Technical University in Prague, Fac. of Biomedical Engineering
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05287334
- Sponsor's protocol ID
- 12229
- Status last verified
- Aug 2022
- First submitted
- 10 Mar 2022
- Last updated
- 9 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Blood Loss Using Electrical Impedance Tomography
- ClinicalTrials.gov ID
- NCT05287334
- Acronym / sponsor ID
- 12229
- Conditions
- Blood Loss
- Keywords
- Blood donation, EIT
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Czech Technical University in PragueUniversity, hospital or other
- Collaborators
- Military University Hospital, Prague
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 10 Oct 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 18 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group assignment. Approx 10-15 voluntary blood donors.
| Arm | Type | Receives |
|---|---|---|
| Voluntary blood donors | Experimental | Device: Electrical impedance tomography measurementVoluntary blood donors undergoing standard blood donation while measuring electrical impedance of the chest . |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- voluntary blood donation
Key exclusion criteria (2 listed)
- standard exclusion criteria for voluntary blood donation based on the transfusion station protocol
- standard exclusion criteria for electrical impedance tomography according to the manufacturer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electrical impedance tomography measurementDuring standard blood donation, donors' chest bioimpedance will be measured using electrical impedance tomography. | Device | Voluntary blood donors |
Primary outcome
Change in chest electrical impedance due to blood loss.
Time frame: Time frame of one voluntary blood donation process (15 min)
A change in the electrical impedance of the chest of a voluntary blood donor caused by a blood donation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vaclav Ort, M.Eng. principal investigator
Czech Technical University in Prague, Fac. of Biomedical Engineering
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrical impedance tomography measurement in people with Blood Loss, run by Czech Technical University in Prague at 2 sites in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vaclav Ort, M.Eng. (+420 731 577 649, ortvacla@fbmi.cvut.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in chest electrical impedance due to blood loss. (time frame: Time frame of one voluntary blood donation process (15 min)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2022; AzTrials last refreshed its copy on 31 Oct 2026.