Cerebral Perfusion Monitoring With Transpharyngeal Ultrasonography

NCT01828411 | Terminated

• 1 other identifier: 056/10
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiopulmonary Bypass

Keywords

Cardiac surgery; Echocardiography; Cerebral perfusion; Intraoperative period

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• clinical feasibility

  intraoperative phase, expected to be ca. 4 hours

Study Arms (2)

Cardiopulmonary bypass group

Patients requiring normothermic (or mild hypothermic) cardiopulmonary bypass.

Device: Transpharyngeal ultrasonography; Device: Duplex sonography

Hypothermic Cardiopulmonary Bypass Group

Patients requiring (deep) hypothermic cardiopulmonary bypass.

Device: Transpharyngeal ultrasonography; Device: Duplex sonography

Interventions

Transpharyngeal ultrasonography DEVICE

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

Cardiopulmonary bypass group; Hypothermic Cardiopulmonary Bypass Group

Duplex sonography DEVICE

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

Cardiopulmonary bypass group; Hypothermic Cardiopulmonary Bypass Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients undergoing cardiac surgery at the University Hospital Bern.

You may qualify if:

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

You may not qualify if:

• Contraindication for transesophageal echocardiography
• Carotid artery stenosis

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Dep. of Anesthesiology and Pain therapy

Bern, 3010, Switzerland

Location

Related 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. doi: 10.1097/00000542-200504000-00038. No abstract available.

  PMID: 15791132 BACKGROUND

• 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.

  PMID: 23040825 BACKGROUND

• 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. doi: 10.1067/mtc.2000.108289.

  PMID: 10962406 BACKGROUND

• 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. doi: 10.1046/j.1540-8175.2001.00711.x.

  PMID: 11801216 BACKGROUND

• Immer FF, Moser B, Krahenbuhl 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.

  PMID: 18442549 BACKGROUND

Study Officials

• Balthasar Eberle, Prof., MD.

  University Hospital Bern, Dep. of Anesthesiology and Pain therapy

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2013
• First Posted: April 10, 2013
• Study Start: April 1, 2013
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: April 5, 2018

Record last verified: 2018-04

Locations

CH (1)