Transpharyngeal Doppler Sonography for Cerebral Perfusion Monitoring

NCT ID: NCT03494413

Last Updated: 2019-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-10

Study Completion Date

2019-05-02

Brief Summary

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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

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Conditions

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Cerebral Perfusion

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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20 patients (1-20) validation arm

Accuracy of cerebral flow measurement between TPS and CDS in 20 patients undergoing cardiovascular surgery with cardiopulmonary bypass

Group Type EXPERIMENTAL

Transpharyngeal Doppler sonography (TPS)

Intervention Type DIAGNOSTIC_TEST

Usage of transpharyngeal Doppler to assess cerebral perfusion during cardiovascular surgery

Conventional colour-coded Duplex sonography (CDS)

Intervention Type DIAGNOSTIC_TEST

Usage of conventional colour-coded Duplex sonography (CDS) to assess cerebral perfusion during cardiovascular surgery

20 patients (21-40) HCA arm

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

Group Type EXPERIMENTAL

Transpharyngeal Doppler sonography (TPS)

Intervention Type DIAGNOSTIC_TEST

Usage of transpharyngeal Doppler to assess cerebral perfusion during cardiovascular surgery

Conventional colour-coded Duplex sonography (CDS)

Intervention Type DIAGNOSTIC_TEST

Usage of conventional colour-coded Duplex sonography (CDS) to assess cerebral perfusion during cardiovascular surgery

Interventions

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Transpharyngeal Doppler sonography (TPS)

Usage of transpharyngeal Doppler to assess cerebral perfusion during cardiovascular surgery

Intervention Type DIAGNOSTIC_TEST

Conventional colour-coded Duplex sonography (CDS)

Usage of conventional colour-coded Duplex sonography (CDS) to assess cerebral perfusion during cardiovascular surgery

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Cardiovascular Surgery
* Age \> 18 yrs
* Informed Consent

Exclusion Criteria

* Contraindication for TPS
* Carotid artery stenosis
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Inselspital, University Hospital Bern, University of Bern

Bern, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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2018-00566

Identifier Type: -

Identifier Source: org_study_id

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