Transpharyngeal Doppler Sonography for Cerebral Perfusion Monitoring

Cerebral Perfusion Clinical Trial

— TaPaS  

Official title:

Evaluation of Transpharyngeal Doppler Sonography as a Cerebral Monitoring Tool in Cardiac Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03494413
• Other study ID #: 2018-00566
• Status: Completed
• Phase: N/A
• Start date: July 10, 2018
• Est. completion date: May 2, 2019

Study information

• Verified date: May 2019
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 2, 2019
• Est. primary completion date: April 3, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Cardiovascular Surgery

• Age > 18 yrs

• Informed Consent

Exclusion Criteria:

• Contraindication for TPS

• Carotid artery stenosis

Related Conditions & MeSH terms

• Cerebral Perfusion

Intervention

Diagnostic Test:
• Transpharyngeal Doppler sonography (TPS)
Usage of transpharyngeal Doppler to assess cerebral perfusion during cardiovascular surgery
• Conventional colour-coded Duplex sonography (CDS)
Usage of conventional colour-coded Duplex sonography (CDS) to assess cerebral perfusion during cardiovascular surgery

Locations

Country	Name	City	State
Switzerland	Inselspital, University Hospital Bern, University of Bern	Bern

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	intraoperative phase, expected to be ca. 4 hours