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Transpharyngeal Doppler Sonography for Cerebral Perfusion Monitoring (TaPaS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03494413
Recruitment Status : Completed
First Posted : April 11, 2018
Last Update Posted : May 7, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

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).

Condition or disease Intervention/treatment Phase
Cerebral Perfusion Diagnostic Test: Transpharyngeal Doppler sonography (TPS) Diagnostic Test: Conventional colour-coded Duplex sonography (CDS) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of Transpharyngeal Doppler Sonography as a Cerebral Monitoring Tool in Cardiac Surgery
Actual Study Start Date : July 10, 2018
Actual Primary Completion Date : April 3, 2019
Actual Study Completion Date : May 2, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

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




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Hypothermic Circulatory Arrest [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Cardiovascular Surgery
  • Age > 18 yrs
  • Informed Consent

Exclusion Criteria:

  • Contraindication for TPS
  • Carotid artery stenosis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03494413


Locations
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Switzerland
Inselspital, University Hospital Bern, University of Bern
Bern, Switzerland, 3010
Sponsors and Collaborators
University Hospital Inselspital, Berne
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Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT03494413    
Other Study ID Numbers: 2018-00566
First Posted: April 11, 2018    Key Record Dates
Last Update Posted: May 7, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No