Clinical Trials Directory

Trials / Completed

CompletedNCT01310608

Effect Study of Modified Transoesophageal Echocardiography on Cerebral Embolization After Cardiothoracic Surgery

Effect of Preoperative Imaging of the Ascending Aorta With Modified Transoesophageal Echocardiography on New Dw-MRI Lesions After Cardiac Surgery

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
32 (actual)
Sponsor
Isala · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

Patients undergoing cardiac surgery frequently develop neurologic complications, ranging from subtle cognitive changes to evident confusion, delirium, and stroke. This continuum of complications is commonly caused by embolization in the brain due to manipulation of atherosclerotic parts of the aorta ascendens (AA) during surgery. Timely detection of AA atherosclerosis before surgery enables the surgeon to consider changes of the surgical plan, to reduce the risk of embolization and thus subsequent neurologic complications. Various methods exist to visualize the AA to detect atherosclerosis. Epiaortic ultrasound scanning has become the gold standard, but is seldom used as it interferes often with surgical plan and can only be used after sternotomy. Transesophageal echocardiography (TEE) is a widely used imaging method permitting evaluation of the aorta preoperatively, but assessment of distal AA is hampered by interposition of air-filled trachea between esophagus and AA. The A-View® (Aortic-view) method, a modification of conventional TEE using a fluidfilled balloon, overcomes this limitation. The safety and diagnostic accuracy of the A-View® have successfully been shown in previous studies. The hypothesis of this study is that the use of A-View will reduce cerebral embolization secondary to a change of surgical technique.

Conditions

Interventions

TypeNameDescription
OTHERA-ViewPre-operative imaging of the thoracic aorta with A-View technique

Timeline

Start date
2011-03-01
Primary completion
2011-03-01
Completion
2011-06-01
First posted
2011-03-08
Last updated
2012-08-09

Source: ClinicalTrials.gov record NCT01310608. Inclusion in this directory is not an endorsement.