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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

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01828411
Acronym
TP-Echo
Enrollment
32
Registered
2013-04-10
Start date
2013-04-30
Completion date
2018-03-31
Last updated
2018-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiopulmonary Bypass

Keywords

Cardiac surgery, Echocardiography, Cerebral perfusion, Intraoperative period

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.

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.

Interventions

DEVICETranspharyngeal ultrasonography

Transpharyngeal Dopplerultrasonography (Device: iE33 xMatrix Philips). Assessment of cerebral blood flow by detection of blood flow velocities in the extracranial carotid arteries.

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

Sponsors

Insel Gruppe AG, University Hospital Bern
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Contraindication for transesophageal echocardiography * Carotid artery stenosis

Design outcomes

Primary

MeasureTime frameDescription
accuracy of cerebral flow velocity measurementintraoperative phase, expected to be ca. 4 hoursCerebral 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

MeasureTime frameDescription
clinical feasibilityintraoperative phase, expected to be ca. 4 hoursClinical 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.

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026