Impact of Anesthesia on the Dimension of the Ascending Aorta

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

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.

Study Overview

• Status: Recruiting
• Conditions: Aortic Aneurysm, Thoracic
• Intervention / Treatment: Other: Trans-esophageal echocardiography

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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Ramat Gan, Israel, 52621
    • Recruiting
    • Sheba Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Aorta dilated; Patients with aorta of 40mm or more who undergo a cardiac surgery. The intervention include: Trans-Esophageal Echocardiography	Other: Trans-esophageal echocardiography; Perform a trans-esophageal echocardiography before and after anesthesia.; Other Names: Cardiac surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
difference in the aortic dimension	10% difference in the aortic dimension before and after anaesthesia	intraoperative

Collaborators and Investigators

• Sponsor: Sheba Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2018
• Primary Completion (Anticipated): January 21, 2022
• Study Completion (Anticipated): January 21, 2022

Study Registration Dates

• First Submitted: January 23, 2018
• First Submitted That Met QC Criteria: February 6, 2018
• First Posted (Actual): February 13, 2018

Study Record Updates

• Last Update Posted (Actual): April 8, 2021
• Last Update Submitted That Met QC Criteria: April 6, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Thoracic
• Other Study ID Numbers: SHEBA-18-4459-ER-CTIL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No