Clinical Trials Logo

Clinical Trial Summary

The aim of this study is to evaluate the accuracy and reliability of intra-operative TEE after the induction of anesthesia when assessing proximal thoracic aorta diameters in a cohort of aortic aneurysm patients.


Clinical Trial Description

Dilatation of the ascending aorta often progresses silently in an asymptomatic patient, until an acute complication occurs (such as a dissection or rupture), which is directly related to the diameter of the aortic. To prevent these extremely harmful situations, aortic replacement surgery, as indicated by significant dilatation of the ascending aorta, could be the option of choice (1). The decision to perform elective surgery depends on the measurement of the thoracic aorta diameter, which would rely on the largest aortic dimension. Trans-thoracic echocardiography (TTE) is widely used to assess the aortic root (2), and results from computed tomography (CT) scans are used to evaluate the ascending aorta beyond the sinotubular junction (3, 4). Both these tests facilitate follow-up evaluation of patients with thoracic aortic aneurysm. Usually, patients are referred for surgery based on the findings of one or both of these examinations. Furthermore, when a patient is referred for surgery, intra-operative trans-esophageal echocardiography (TEE) is often performed after induction of the anesthesia in order to evaluate the aortic dimension and valve function. In some cases, the diameter of the aorta is considered borderline for replacement, in which case the TEE measurement could reverse the decision-making, especially when the indication for surgery is due to valve pathology, with the aorta being a secondary consideration. From the investigators experience, intra-operative TEE aortic measurements after the anesthesia are not entirely accurate, and could under-estimate the diameter of the aorta. Relying on intra-operative TEE measurements could result in under-treatment of the dilated aorta, especially when its replacement is secondary to other cardiac pathologies (e.g. AVR, CABG) that require surgery. Influence of intra-operative anesthesia on TEE measurements of the aorta are not described in the current literature. If the investigators hypothesis is correct, adjustments will need to be made regarding the surgical management of patients with borderline aortic dimensions. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03431870
Study type Interventional
Source Sheba Medical Center
Contact Diana Kogan
Phone 972-52-8646402
Email Diana.Kogan@sheba.health.gov.il
Status Recruiting
Phase N/A
Start date January 21, 2018
Completion date January 21, 2022

See also
  Status Clinical Trial Phase
Active, not recruiting NCT02777593 - Evaluation of the GORE® TBE Device in the Treatment of Lesions of the Aortic Arch and Descending Thoracic Aorta, Zone 2 N/A
Completed NCT02876263 - Noninvasive Neuromonitoring of Surgery of the Thoracic Aorta N/A
Terminated NCT02538822 - Risk of Rupture of Aneurysms of the Thoracic Ascending Aorta (ATA) From the Dynamic Imaging N/A
Completed NCT04930172 - TOtal tRansfemoral branCHed endovasCular tHoracoabdominal Aortic Repair Registry
Completed NCT03207568 - RE-GENERATION: The Safety and Performance of the Relay Pro and Relay NBS Pro Stent-graft Devices in the European Union (EU) N/A
Recruiting NCT03010514 - A Registry Study on Genetics and Biomarkers of Thoracic Aortic Aneurysm/Dissection N/A
Completed NCT02266342 - GORE® TAG® Thoracic Endoprosthesis French Mandatory Registry
Completed NCT00757003 - To Evaluate the Safety and Efficacy for GORE TAG Thoracic Endoprosthesis in the Treatment of Thoracic Aortic Disease Phase 3
Recruiting NCT03574311 - Preoperative Intravenous Ferric Carboxymaltose and Placebo in the Treatment of Patients Undergoing Cardiac Surgery Phase 4
Suspended NCT03410420 - Detection of Hypoxia in Human Thoracic Aorta Using Pimonidazole Hydrochloride Phase 1
Recruiting NCT05703893 - Investigation of the Neurovegetative Pattern in Patients With Thoracic Aortic Aneurysms (TAA)
Enrolling by invitation NCT05800743 - Evaluation of the GORE® Ascending Stent Graft N/A
Completed NCT02253082 - Vasculopathic Injury and Plasma as Endothelial Rescue - OCTAplas Trial (EudraCT no. 2014-000452-28) Phase 4
Recruiting NCT02323581 - Endovascular Treatment of TAAA and Aortic Arch Aneurysms Using Fenestrated and Branched Stent Grafts N/A
Active, not recruiting NCT03414866 - Thoraflex Hybrid Post-Market Study
Recruiting NCT01985906 - Safety and Efficacy of Multiple Overlapping Uncovered Stents for Pararenal Aortic Aneurysm Repair N/A
Active, not recruiting NCT02818972 - RelayPro Thoracic Stent-Graft in Subjects With Thoracic Aortic Aneurysms and Penetrating Atherosclerotic Ulcers N/A
Completed NCT03479164 - Development of Ultra-Low Dose CT Based Screening for Aortic Aneurysms N/A
Completed NCT01775046 - Valiant Thoracic Stent Graft With the Captivia Delivery System in the Treatment of Descending Thoracic Aortic Diseases (VALIANT CAPTIVIA France)
Recruiting NCT04814238 - Minimally Invasive Aortic Root and Aorta surGery rEgistry