Cerebral Perfusion Monitoring With Transpharyngeal Ultrasonography (TP-Echo)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by University Hospital Inselspital, Berne
Sponsor:
Information provided by (Responsible Party):
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT01828411
First received: March 27, 2013
Last updated: April 29, 2014
Last verified: April 2014

March 27, 2013
April 29, 2014
April 2013
November 2014   (final data collection date for primary outcome measure)
accuracy of cerebral flow velocity measurement [ Time Frame: intraoperative phase, expected to be ca. 4 hours ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01828411 on ClinicalTrials.gov Archive Site
clinical feasibility [ Time Frame: intraoperative phase, expected to be ca. 4 hours ] [ Designated as safety issue: No ]
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.
Same as current
Not Provided
Not Provided
 
Cerebral Perfusion Monitoring With Transpharyngeal Ultrasonography
Monitoring the Brain in On-pump Cardiovascular Surgery: The Role of Transpharyngeal Ultrasonography as a Non-invasive Adjunct to Assess Cerebral Perfusion

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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Not Provided
Not Provided
Probability Sample

Patients undergoing cardiac surgery at the University Hospital Bern.

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 during coronary artery bypass grafting.
  • Device: Duplex sonography and Transcranial Doppler Ultrasonography
    Assessment of cerebral blood flow by detection of blood flow velocities in the extracranial carotid and middle cerebral arteries during coronary artery bypass grafting.
  • Coronary artery bypass group (CABG)
    Patients with coronary heart disease requiring coronary artery bypass grafting on cardiopulmonary bypass.
    Interventions:
    • Device: Transpharyngeal ultrasonography
    • Device: Duplex sonography and Transcranial Doppler Ultrasonography
  • Thoracic aortic disease group (TAD)
    Patients with thoracic aortic disease (ascending aortic dissection or aneurysm) requiring replacement of the ascending aorta on cardiopulmonary bypass with use of hypothermic circulatory arrest and antegrade cerebral perfusion.
    Interventions:
    • Device: Transpharyngeal ultrasonography
    • Device: Duplex sonography and Transcranial Doppler Ultrasonography

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
32
December 2014
November 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Signed informed consent
  • Coronary artery bypass grafting or
  • Replacement of thoracic aorta

Exclusion Criteria

  • Contraindication for transesophageal echocardiography
  • Carotid artery stenosis
Both
18 Years and older
No
Contact: Gabor Erdoes, MD +41 31 632 2726 Gabor.Erdoes@insel.ch
Switzerland
 
NCT01828411
056/10
No
University Hospital Inselspital, Berne
University Hospital Inselspital, Berne
Not Provided
Study Chair: Balthasar Eberle, Prof., MD. University Hospital Bern, Dep. of Anesthesiology and Pain therapy
University Hospital Inselspital, Berne
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP