Stroke VolumeSVEITNCT02639468
Electric Impedance Tomography
A study testing Stroke Volume estimation using electrical impedance tomography in people with Stroke Volume, run by CSEM Centre Suisse d'Electronique et de Microtechnique SA - Recherche et Developpement at 1 site in Switzerland.
Trial summary
Evaluation of electrical impedance tomography to non-invasively monitor stroke volume when compared to reference measurements performed via right heart thermodilution Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Stroke Volume
- What is being tested?
- Stroke Volume estimation using electrical impedance tomography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteSwitzerland
- Study dates
- Apr 2016to 12 Jan 2018
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing cardiac surgery which requires placement of pulmonary catheter
- Patients with right heart catheterization for diagnostic or therapeutic reasons
Who cannot join
- Patient unable to understand the study
- Patient unable to provide written consent or refusing his/her participation
- Patient suffering from a severe valvular insufficiency
- Patient allergic to ECG electrodes
Trial locations and contacts
1 site in 1 country.
About this study
Evaluation of electrical impedance tomography to non-invasively monitor stroke volume when compared to reference measurements performed via right heart thermodilution
- Conditions
- Stroke Volume
- Being tested
- Stroke Volume estimation using electrical impedance tomography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stroke Volume estimation using electrical impedance tomographyDevice
| Study group | Role | What they receive |
|---|---|---|
| Tomographie par impédance électrique | Experimental | Tomographie par impédance électrique Receives: Device: Stroke Volume estimation using electrical impedance tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of stroke volume values measured via pulmonary catheter compared to EIT-derived stroke volume estimates.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2015 (estimated)
- Study startApr 2016
- Primary completion12 Jan 2018
- Study completion12 Jan 2018
Why it stopped: protocol not fully appropriate technical issues with EIT device
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke VolumeStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- CSEM Centre Suisse d'Electronique et de Microtechnique SA - Recherche et Developpement
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Centre Hospitalier Universitaire Vaudois
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02639468
- Sponsor's protocol ID
- SVEIT
- Acronym
- SVEIT
- Status last verified
- Nov 2018
- First submitted
- 17 Dec 2015
- Last updated
- 27 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electric Impedance Tomography
- ClinicalTrials.gov ID
- NCT02639468
- Acronym / sponsor ID
- SVEIT / SVEIT
- Conditions
- Stroke Volume
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: protocol not fully appropriate technical issues with EIT device
- Enrolment
- 13 participants (actual)
- Lead sponsor
- CSEM Centre Suisse d'Electronique et de Microtechnique SA - Recherche et DeveloppementIndustry (pharma, biotech, devices)
- Collaborators
- Centre Hospitalier Universitaire Vaudois
- Study start
- Apr 2016
- Primary completion
- 12 Jan 2018 (actual)
- Study completion
- 12 Jan 2018 (actual)
- First posted
- 24 Dec 2015 (estimated)
- 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.
Evaluation of electrical impedance tomography to non-invasively monitor stroke volume when compared to reference measurements performed via right heart thermodilution
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tomographie par impédance électrique | Experimental | Device: Stroke Volume estimation using electrical impedance tomographyTomographie par impédance électrique |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoing cardiac surgery which requires placement of pulmonary catheter
- Patients with right heart catheterization for diagnostic or therapeutic reasons
Key exclusion criteria (4 listed)
- Patient unable to understand the study
- Patient unable to provide written consent or refusing his/her participation
- Patient suffering from a severe valvular insufficiency
- Patient allergic to ECG electrodes
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 |
|---|---|---|
| Stroke Volume estimation using electrical impedance tomography | Device | Tomographie par impédance électrique |
Primary outcome
Correlation of stroke volume values measured via pulmonary catheter compared to EIT-derived stroke volume estimates.
Time frame: 12 months
Results and safety
The study was stopped early (reason given: protocol not fully appropriate technical issues with EIT device). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2018.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stroke Volume estimation using electrical impedance tomography in people with Stroke Volume, run by CSEM Centre Suisse d'Electronique et de Microtechnique SA - Recherche et Developpement at 1 site in Switzerland.
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 2 inclusion and 4 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: stopped early, as of the sponsor's last update on 27 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. 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?
The study was stopped early (reason given: protocol not fully appropriate technical issues with EIT device). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of stroke volume values measured via pulmonary catheter compared to EIT-derived stroke volume estimates. (time frame: 12 months). 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 27 Nov 2018.