Transpharyngeal Doppler Sonography for Cerebral Perfusion Monitoring

Not Applicable

Completed

• Conditions: Cerebral Perfusion
• Interventions: Diagnostic Test: Transpharyngeal Doppler sonography (TPS); Diagnostic Test: Conventional colour-coded Duplex sonography (CDS)

• Registration Number: NCT03494413
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-04-03
• Study First Submitted QC: 2018-04-03
• Study First Posted: 2018-04-11
• Study Start: 2018-07-10
• Primary Completion: 2019-04-03
• Status Verified: 2019-05
• Study Completion: 2019-05-02
• Last Update Submitted: 2019-05-06
• Last Update Posted: 2019-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Cardiovascular Surgery
• Age > 18 yrs
• Informed Consent

Exclusion Criteria

• Contraindication for TPS
• Carotid artery stenosis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
20 patients (1-20) validation arm	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	Conventional colour-coded Duplex sonography (CDS)	Assessment and comparison of TPS and CDS in hypothermic circulatory arrest (HCA) during cardiovascular surgery
20 patients (1-20) validation arm	Transpharyngeal Doppler sonography (TPS)	Accuracy of cerebral flow measurement between TPS and CDS in 20 patients undergoing cardiovascular surgery with cardiopulmonary bypass
20 patients (21-40) HCA arm	Transpharyngeal Doppler sonography (TPS)	Assessment and comparison of TPS and CDS in hypothermic circulatory arrest (HCA) during cardiovascular surgery

Primary Outcome Measures

Name	Time	Method
Accuracy of cerebral flow velocity measurement	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.

Secondary Outcome Measures

Name	Time	Method
Hypothermic Circulatory Arrest	intraoperative phase, expected to be ca. 4 hours	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.

Trial Locations

Locations (1)

Inselspital, University Hospital Bern, University of Bern; 🇨🇭 Bern, Switzerland