Cerebral Perfusion Monitoring With Transpharyngeal Ultrasonography

Cardiopulmonary Bypass Clinical Trial

— TP-Echo  

Official title:

Monitoring the Brain in On-pump Cardiovascular Surgery: The Role of Transpharyngeal Ultrasonography as a Non-invasive Adjunct to Assess Cerebral Perfusion

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01828411
• Other study ID #: 056/10
• Status: Terminated
• First received: March 27, 2013
• Last updated: April 3, 2018
• Start date: April 2013
• Est. completion date: March 2018

Study information

• Verified date: April 2018
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 32
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Signed informed consent

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

Exclusion Criteria

• Contraindication for transesophageal echocardiography

• Carotid artery stenosis

Related Conditions & MeSH terms

• Cardiopulmonary Bypass

Intervention

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.
• 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.

Locations

Country	Name	City	State
Switzerland	Dep. of Anesthesiology and Pain therapy	Bern

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

References & Publications (5)

Bevilacqua S, Romagnoli S, Ciappi F, Ridolfi N, Codecasa R, Rostagno C, Sorbara C. Transpharyngeal ultrasonography for cannulation of the internal jugular vein. Anesthesiology. 2005 Apr;102(4):873-4. — View Citation

Immer FF, Moser B, Krähenbühl ES, Englberger L, Stalder M, Eckstein FS, Carrel T. Arterial access through the right subclavian artery in surgery of the aortic arch improves neurologic outcome and mid-term quality of life. Ann Thorac Surg. 2008 May;85(5):1614-8; discussion 1618. doi: 10.1016/j.athoracsur.2007.11.027. — View Citation

Nanda NC, Miller AP, Nekkanti R, Aaluri S. Transpharyngeal echocardiographic imaging of the right and left carotid arteries. Echocardiography. 2001 Nov;18(8):711-6. — View Citation

Orihashi K, Matsuura Y, Sueda T, Watari M, Okada K, Sugawara Y, Ishii O. Aortic arch branches are no longer a blind zone for transesophageal echocardiography: a new eye for aortic surgeons. J Thorac Cardiovasc Surg. 2000 Sep;120(3):466-72. — View Citation

Shimizu H, Matayoshi T, Morita M, Ueda T, Yozu R. Total arch replacement under flow monitoring during selective cerebral perfusion using a single pump. Ann Thorac Surg. 2013 Jan;95(1):29-34. doi: 10.1016/j.athoracsur.2012.08.007. Epub 2012 Oct 4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	accuracy of cerebral flow velocity measurement	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.	intraoperative phase, expected to be ca. 4 hours
Secondary	clinical feasibility	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.	intraoperative phase, expected to be ca. 4 hours