Transpharyngeal Doppler Sonography for Cerebral Perfusion Monitoring (TaPaS)

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).

Study Overview

• Status: Completed
• Conditions: Cerebral Perfusion
• Intervention / Treatment: Diagnostic test: Transpharyngeal Doppler sonography (TPS); Diagnostic test: Conventional colour-coded Duplex sonography (CDS)

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Bern, Switzerland, 3010
    • Inselspital, University Hospital Bern, University of Bern

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Cardiovascular Surgery
• Age > 18 yrs
• Informed Consent

Exclusion Criteria:

• Contraindication for TPS
• Carotid artery stenosis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 20 patients (1-20) validation arm; Accuracy of cerebral flow measurement between TPS and CDS in 20 patients undergoing cardiovascular surgery with cardiopulmonary bypass	Diagnostic test: Transpharyngeal Doppler sonography (TPS); Usage of transpharyngeal Doppler to assess cerebral perfusion during cardiovascular surgery; Diagnostic test: Conventional colour-coded Duplex sonography (CDS); Usage of conventional colour-coded Duplex sonography (CDS) to assess cerebral perfusion during cardiovascular surgery
Experimental: 20 patients (21-40) HCA arm; Assessment and comparison of TPS and CDS in hypothermic circulatory arrest (HCA) during cardiovascular surgery	Diagnostic test: Transpharyngeal Doppler sonography (TPS); Usage of transpharyngeal Doppler to assess cerebral perfusion during cardiovascular surgery; Diagnostic test: Conventional colour-coded Duplex sonography (CDS); Usage of conventional colour-coded Duplex sonography (CDS) to assess cerebral perfusion during cardiovascular surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital Inselspital, Berne

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2018
• Primary Completion (Actual): April 3, 2019
• Study Completion (Actual): May 2, 2019

Study Registration Dates

• First Submitted: April 3, 2018
• First Submitted That Met QC Criteria: April 3, 2018
• First Posted (Actual): April 11, 2018

Study Record Updates

• Last Update Posted (Actual): May 7, 2019
• Last Update Submitted That Met QC Criteria: May 6, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 2018-00566

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No