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

Phase 3

Completed

• Conditions: Coronary Artery Atherosclerosis
• Interventions: Other: A-View

• Registration Number: NCT01310608
• Lead Sponsor: Isala

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03
• Primary Completion: 2011-03
• Study First Submitted: 2011-03-07
• Study First Submitted QC: 2011-03-07
• Study First Posted: 2011-03-08
• Study Completion: 2011-06
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-07
• Last Update Posted: 2012-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• Isolated CABG
• Elective surgery
• Stroke Risk Index <75(Newman, '96)

Exclusion Criteria

• Other than isolated CABG
• Contra-indication for TEE
• Contra-indication for A-View
• Contra-indication for MRI

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A-View	A-View	-

Primary Outcome Measures

Name	Time	Method
New diffusion-weighted lesions on cerebral MRI	3 - 4 Days after intervention

Secondary Outcome Measures

Name	Time	Method
The number, size, and location of new ischemic lesions on the postoperative DW-MRI	3 - 4 Days after intervention
Any neurologic event during the first six postoperative weeks, which is manifested as either stroke, or transient ischemic attack (TIA), epileptic insults, or delirium, or cognitive deficit	6 weeks postoperative
Stroke or TIA during the first three postoperative months	3 months postoperative
Delirium during hospital stay	Until hospital discharge
Quality of life	6 weeks and 1 year after the intervention
Number of "HITS" detected by Transcranial Doppler	peroperive
Incidence of Near Infrared Spectrography desaturations (NIRO 2000)	Peroperative
Short psychometric test	6 weeks after intervention