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Clinical Trials/NCT03494413
NCT03494413CompletedNot Applicable

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

Insel Gruppe AG, University Hospital Bern2 sites in 1 country30 target enrollmentStarted: July 10, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
30
Locations
2
Primary Endpoint
Accuracy of cerebral flow velocity measurement

Study Overview

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).

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Sequential
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Cardiovascular Surgery
  • Age > 18 yrs
  • Informed Consent

Exclusion Criteria

  • Contraindication for TPS
  • Carotid artery stenosis

Arms & Interventions

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

Intervention: Transpharyngeal Doppler sonography (TPS) (Diagnostic Test)

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

Intervention: Conventional colour-coded Duplex sonography (CDS) (Diagnostic Test)

20 patients (21-40) HCA arm

Experimental

Assessment and comparison of TPS and CDS in hypothermic circulatory arrest (HCA) during cardiovascular surgery

Intervention: Transpharyngeal Doppler sonography (TPS) (Diagnostic Test)

20 patients (21-40) HCA arm

Experimental

Assessment and comparison of TPS and CDS in hypothermic circulatory arrest (HCA) during cardiovascular surgery

Intervention: Conventional colour-coded Duplex sonography (CDS) (Diagnostic Test)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Hypothermic Circulatory Arrest(intraoperative phase, expected to be ca. 4 hours)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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