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Clinical Trials/NCT03431870
NCT03431870
Unknown
Not Applicable

Prospective Study to Examine the Impact of Anesthesia on the Dimension of the Ascending Aorta in Patients With a Dilated Aorta Who Undergo Open-heart Surgery

Sheba Medical Center1 site in 1 country20 target enrollmentJanuary 21, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Aortic Aneurysm, Thoracic
Sponsor
Sheba Medical Center
Enrollment
20
Locations
1
Primary Endpoint
difference in the aortic dimension
Last Updated
5 years ago

Overview

Brief 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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
January 21, 2018
End Date
January 21, 2022
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Ascending aorta of 40 mm and above
  • Patients who undergo cardiac surgery

Exclusion Criteria

  • Unstable patients
  • Patients who underwent a previous cardiac surgery
  • Patients who were diagnosed with aortic dissection

Outcomes

Primary Outcomes

difference in the aortic dimension

Time Frame: intraoperative

10% difference in the aortic dimension before and after anaesthesia

Study Sites (1)

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