Cerebral PerfusionTaPaSNCT03494413
Transpharyngeal Doppler Sonography for Cerebral Perfusion Monitoring
A study testing Transpharyngeal Doppler sonography (TPS) and Conventional colour-coded Duplex sonography (CDS) in people with Cerebral Perfusion, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
This prospective interventional study investigates transpharyngeal sonography (TPS) as an additional neuromonitoring strategy to assess cerebral perfusion during cardiovascular surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebral Perfusion
- What is being tested?
- Transpharyngeal Doppler sonography (TPS) and Conventional colour-coded Duplex sonography (CDS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- 10 Jul 2018to 2 May 2019
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cardiovascular Surgery
- Age > 18 yrs
- Informed Consent
Who cannot join
- Contraindication for TPS
- Carotid artery stenosis
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Inselspital, University Hospital Bern, University of Bern
Bern, 3010
About this study
Official title: Evaluation of Transpharyngeal Doppler Sonography as a Cerebral Monitoring Tool in Cardiac Surgery
This prospective interventional study investigates transpharyngeal sonography (TPS) as an additional neuromonitoring strategy to assess cerebral perfusion during cardiovascular surgery. In the first part of the study the investigators will investigate the feasibility of TPS for visualization of aortic arch branches including the innominate and the carotid arteries in patients undergoing cardiac surgery with cardiopulmonary bypass. In the second part the investigators plan to adopt the investigators previous experiences on TPS to a selected population of patients undergoing ascending aortic and/or arch repair in hypothermic circulatory arrest (HCA).
- Conditions
- Cerebral Perfusion
- Being tested
- Transpharyngeal Doppler sonography (TPS), Conventional colour-coded Duplex sonography (CDS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transpharyngeal Doppler sonography (TPS)Diagnostic test
Usage of transpharyngeal Doppler to assess cerebral perfusion during cardiovascular surgery
Conventional colour-coded Duplex sonography (CDS)Diagnostic test
Usage of conventional colour-coded Duplex sonography (CDS) to assess cerebral perfusion during cardiovascular surgery
| Study group | Role | What they receive |
|---|---|---|
| 20 patients (1-20) validation arm | Experimental | Accuracy of cerebral flow measurement between TPS and CDS in 20 patients undergoing cardiovascular surgery with cardiopulmonary bypass Receives: Diagnostic Test: Transpharyngeal Doppler sonography (TPS); Diagnostic Test: Conventional colour-coded Duplex sonography (CDS) |
| 20 patients (21-40) HCA arm | Experimental | Assessment and comparison of TPS and CDS in hypothermic circulatory arrest (HCA) during cardiovascular surgery Receives: Diagnostic Test: Transpharyngeal Doppler sonography (TPS); Diagnostic Test: Conventional colour-coded Duplex sonography (CDS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of cerebral flow velocity measurement
Cerebral blood flow velocity measurements will be performed with transpharyngeal Doppler sonography (TPS) and conventional colour-coded Duplex sonography (CDS). Doppler flow velocities (obtained at the same intraoperative phase and at the same time) will be compared between TPS and CDS TPS and different Doppler techniques.
Measured: intraoperative phase, expected to be ca. 4 hours
Secondary outcomes (1)
Hypothermic Circulatory Arrest
Doppler flow velocities (obtained with both methods in the Phase of hypothermic circulatory arrest - intraoperatively) will be compared between TPS and CDS TPS and different Doppler techniques.
Measured: intraoperative phase, expected to be ca. 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2018
- Study start10 Jul 2018
- Primary completion3 Apr 2019
- Study completion2 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PerfusionStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03494413
- Sponsor's protocol ID
- 2018-00566
- Other IDs
- 2018
- Acronym
- TaPaS
- Status last verified
- May 2019
- First submitted
- 3 Apr 2018
- Last updated
- 7 May 2019
- Results posted
- No
- Data monitoring committee
- 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 7 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Transpharyngeal Doppler Sonography as a Cerebral Monitoring Tool in Cardiac Surgery
- ClinicalTrials.gov ID
- NCT03494413
- Acronym / sponsor ID
- TaPaS / 2018-00566
- Conditions
- Cerebral Perfusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 10 Jul 2018 (actual)
- Primary completion
- 3 Apr 2019 (actual)
- Study completion
- 2 May 2019 (actual)
- First posted
- 11 Apr 2018 (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.
This prospective interventional study investigates transpharyngeal sonography (TPS) as an additional neuromonitoring strategy to assess cerebral perfusion during cardiovascular surgery. In the first part of the study the investigators will investigate the feasibility of TPS for visualization of aortic arch branches including the innominate and the carotid arteries in patients undergoing cardiac surgery with cardiopulmonary bypass. In the second part the investigators plan to adopt the investigators previous experiences on TPS to a selected population of patients undergoing ascending aortic and/or arch repair in hypothermic circulatory arrest (HCA).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 20 patients (1-20) validation arm | Experimental | Diagnostic Test: Transpharyngeal Doppler sonography (TPS), Diagnostic Test: Conventional colour-coded Duplex sonography (CDS)Accuracy of cerebral flow measurement between TPS and CDS in 20 patients undergoing cardiovascular surgery with cardiopulmonary bypass |
| 20 patients (21-40) HCA arm | Experimental | Diagnostic Test: Transpharyngeal Doppler sonography (TPS), Diagnostic Test: Conventional colour-coded Duplex sonography (CDS)Assessment and comparison of TPS and CDS in hypothermic circulatory arrest (HCA) during cardiovascular surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Cardiovascular Surgery
- Age > 18 yrs
- Informed Consent
Key exclusion criteria (2 listed)
- Contraindication for TPS
- Carotid artery stenosis
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 |
|---|---|---|
| Transpharyngeal Doppler sonography (TPS)Usage of transpharyngeal Doppler to assess cerebral perfusion during cardiovascular surgery | Diagnostic test | 20 patients (1-20) validation arm, 20 patients (21-40) HCA arm |
| Conventional colour-coded Duplex sonography (CDS)Usage of conventional colour-coded Duplex sonography (CDS) to assess cerebral perfusion during cardiovascular surgery | Diagnostic test | 20 patients (1-20) validation arm, 20 patients (21-40) HCA arm |
Primary outcome
Accuracy of cerebral flow velocity measurement
Time frame: intraoperative phase, expected to be ca. 4 hours
Cerebral blood flow velocity measurements will be performed with transpharyngeal Doppler sonography (TPS) and conventional colour-coded Duplex sonography (CDS). Doppler flow velocities (obtained at the same intraoperative phase and at the same time) will be compared between TPS and CDS TPS and different Doppler techniques.
1 secondary outcome
Hypothermic Circulatory Arrest
Time frame: intraoperative phase, expected to be ca. 4 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2019.
- 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 Transpharyngeal Doppler sonography (TPS) and Conventional colour-coded Duplex sonography (CDS) in people with Cerebral Perfusion, run by Insel Gruppe AG, University Hospital Bern 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 3 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: finished, as of the sponsor's last update on 7 May 2019. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Accuracy of cerebral flow velocity measurement (time frame: intraoperative phase, expected to be ca. 4 hours). 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 7 May 2019.