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Cerebral Perfusion Monitoring With Transpharyngeal Ultrasonography (TP-Echo)

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ClinicalTrials.gov Identifier: NCT01828411
Recruitment Status : Terminated
First Posted : April 10, 2013
Last Update Posted : April 5, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

Brief Summary:

This prospective observational pilot study investigates transpharyngeal ultrasonography (TPU) as an additional neuromonitoring strategy to assess cerebral perfusion during on-pump cardiovascular surgery.

In the first part of the study the investigators will investigate the feasibility of TPU for visualization of aortic arch branches including the innominate and the carotid arteries in twenty patients undergoing coronary artery bypass grafting with extracorporeal circulation (cohort 1.). In the second part the investigators plan to adopt the investigators previous experiences on TPU to a selected population of twelve patients undergoing ascending aortic and/or arch repair in deep hypothermic circulatory arrest (DHCA, cohort 2.). In contrast to cohort 1., patients in cohort 2. are exposed intraoperatively to intermittent cerebral perfusion stops or reductions due to surgical procedure, perfusion technique and their underlying disease (aortic dissection or aortic aneurysm).

The investigators hypothesize that cerebral perfusion monitoring using TPU as a non-invasive technique provides a simple and real-time adjunct to assess blood flow velocity in the extracranial cephalic vessels with Doppler ultrasound. Especially in aortic arch surgery with its inherent risk of cerebral hypoperfusion TPU might be a valuable adjunct to routine.


Condition or disease Intervention/treatment
Cardiopulmonary Bypass Device: Transpharyngeal ultrasonography Device: Duplex sonography

Detailed Description:

Background

Cerebral hypo- or malperfusion during cardiovascular surgery can lead to grave consequences including transient cerebral ischemia or stroke impairing patient`s daily life and affect surgical outcome. For this reason a multimodal neuromonitoring strategy using a variety of devices (evoked potentials, near-infrared spectroscopy, transcranial Doppler ultrasonography) with different technologies has been recommended by medical societies. These techniques have various limitations and cannot be used in all clinical situations. In contrast, transpharyngeal ultrasonography (TPU) represents a simple and readily available technique: the transesophageal echocardiography probe, routinely placed in most cardiac surgical patients for monitoring and assessment of surgical results, will be withdrawn into the upper esophagus making the visualization of supraaortic branches possible.

To date, there are several reports about imaging of aortic arch branches using TPU. The utility of this technique, however, for systematic cerebrovascular monitoring has not have been investigated so far.

Objective

The aim of this study is to investigate TPU as a cerebrovascular monitoring adjunct in two cohorts of on-pump cardiac surgery procedures. Clinical feasibility and diagnostic accuracy of antegrade carotid flow detection are compared to the established reference methods of Duplex sonography and transcranial Doppler ultrasound.

Methods

All patients receive anesthetic and surgical management according to institutional standards. Patient enrollment in the study occurs consecutively and unblinded for surgical procedure.

All patients receive TPU, Duplex sonography and transcranial Doppler examination after anesthesia induction preoperatively, during extracorporeal circulation and after weaning from cardiopulmonary bypass. In addition, the patients in cohort 2.(ascending aortic repair with DHCA) receive above mentioned noninvasive ultrasound / Doppler measurements also during the period of DHCA with and without antegrade cerebral perfusion.

Image acquisition and data extraction are conducted by different persons to avoid investigator-related bias.


Study Type : Observational
Actual Enrollment : 32 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Monitoring the Brain in On-pump Cardiovascular Surgery: The Role of Transpharyngeal Ultrasonography as a Non-invasive Adjunct to Assess Cerebral Perfusion
Study Start Date : April 2013
Actual Primary Completion Date : March 2018
Actual Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Group/Cohort Intervention/treatment
Cardiopulmonary bypass group
Patients requiring normothermic (or mild hypothermic) cardiopulmonary bypass.
Device: Transpharyngeal ultrasonography
Transpharyngeal Dopplerultrasonography (Device: iE33 xMatrix Philips). Assessment of cerebral blood flow by detection of blood flow velocities in the extracranial carotid arteries.

Device: Duplex sonography
Assessment of cerebral blood flow by detection of blood flow velocities in the extracranial carotid and middle cerebral arteries during coronary artery bypass grafting.

Hypothermic Cardiopulmonary Bypass Group
Patients requiring (deep) hypothermic cardiopulmonary bypass.
Device: Transpharyngeal ultrasonography
Transpharyngeal Dopplerultrasonography (Device: iE33 xMatrix Philips). Assessment of cerebral blood flow by detection of blood flow velocities in the extracranial carotid arteries.

Device: Duplex sonography
Assessment of cerebral blood flow by detection of blood flow velocities in the extracranial carotid and middle cerebral arteries during coronary artery bypass grafting.




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 using the pulsed wave Doppler technique. Doppler peak flow velocities (obtained at the same intraoperative phase and at the same time) will be compared between the different Doppler techniques.


Secondary Outcome Measures :
  1. clinical feasibility [ Time Frame: intraoperative phase, expected to be ca. 4 hours ]
    Clinical feasibility will be assessed by analyzing the accuracy of data concordance, i.e. location of cerebral blood vessel, blood flow velocity and cerebral vessel area between the different Doppler techniques. Data will be plotted using Bland-Altman analysis.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients undergoing cardiac surgery at the University Hospital Bern.
Criteria

Inclusion Criteria:

  • Signed informed consent
  • Cardiopulmonary bypass procedure (normo-(group 1) or hypothermic (group 2))

Exclusion Criteria

  • Contraindication for transesophageal echocardiography
  • 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): NCT01828411


Locations
Switzerland
Dep. of Anesthesiology and Pain therapy
Bern, Switzerland, 3010
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
Study Chair: Balthasar Eberle, Prof., MD. University Hospital Bern, Dep. of Anesthesiology and Pain therapy

Publications:
Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT01828411     History of Changes
Other Study ID Numbers: 056/10
First Posted: April 10, 2013    Key Record Dates
Last Update Posted: April 5, 2018
Last Verified: April 2018

Keywords provided by University Hospital Inselspital, Berne:
Cardiac surgery
Echocardiography
Cerebral perfusion
Intraoperative period