Transpharyngeal Doppler Sonography for Cerebral Perfusion Monitoring
TaPaS
Evaluation of Transpharyngeal Doppler Sonography as a Cerebral Monitoring Tool in Cardiac Surgery
1 other identifier
interventional
30
1 country
1
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 3, 2018
CompletedFirst Posted
Study publicly available on registry
April 11, 2018
CompletedStudy Start
First participant enrolled
July 10, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 3, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 2, 2019
CompletedMay 7, 2019
May 1, 2019
9 months
April 3, 2018
May 6, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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.
intraoperative phase, expected to be ca. 4 hours
Secondary Outcomes (1)
Hypothermic Circulatory Arrest
intraoperative phase, expected to be ca. 4 hours
Study Arms (2)
20 patients (1-20) validation arm
EXPERIMENTALAccuracy of cerebral flow measurement between TPS and CDS in 20 patients undergoing cardiovascular surgery with cardiopulmonary bypass
20 patients (21-40) HCA arm
EXPERIMENTALAssessment and comparison of TPS and CDS in hypothermic circulatory arrest (HCA) during cardiovascular surgery
Interventions
Usage of transpharyngeal Doppler to assess cerebral perfusion during cardiovascular surgery
Usage of conventional colour-coded Duplex sonography (CDS) to assess cerebral perfusion during cardiovascular surgery
Eligibility Criteria
You may qualify if:
- Cardiovascular Surgery
- Age \> 18 yrs
- Informed Consent
You may not qualify if:
- Contraindication for TPS
- Carotid artery stenosis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Inselspital, University Hospital Bern, University of Bern
Bern, 3010, Switzerland
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 3, 2018
First Posted
April 11, 2018
Study Start
July 10, 2018
Primary Completion
April 3, 2019
Study Completion
May 2, 2019
Last Updated
May 7, 2019
Record last verified: 2019-05
Data Sharing
- IPD Sharing
- Will not share