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Impact of Anesthesia on the Dimension of the Ascending Aorta

Primary Purpose

Aortic Aneurysm, Thoracic

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Trans-esophageal echocardiography
Sponsored by
Sheba Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Aortic Aneurysm, Thoracic

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sheba medical centerRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Aorta dilated

Arm Description

Patients with aorta of 40mm or more who undergo a cardiac surgery. The intervention include: Trans-Esophageal Echocardiography

Outcomes

Primary Outcome Measures

difference in the aortic dimension
10% difference in the aortic dimension before and after anaesthesia

Secondary Outcome Measures

Full Information

First Posted
January 23, 2018
Last Updated
April 6, 2021
Sponsor
Sheba Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03431870
Brief Title
Impact of Anesthesia on the Dimension of the Ascending Aorta
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 21, 2018 (Actual)
Primary Completion Date
January 21, 2022 (Anticipated)
Study Completion Date
January 21, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sheba Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Aneurysm, Thoracic

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Aorta dilated
Arm Type
Other
Arm Description
Patients with aorta of 40mm or more who undergo a cardiac surgery. The intervention include: Trans-Esophageal Echocardiography
Intervention Type
Other
Intervention Name(s)
Trans-esophageal echocardiography
Other Intervention Name(s)
Cardiac surgery
Intervention Description
Perform a trans-esophageal echocardiography before and after anesthesia.
Primary Outcome Measure Information:
Title
difference in the aortic dimension
Description
10% difference in the aortic dimension before and after anaesthesia
Time Frame
intraoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Diana Kogan
Phone
972-52-8646402
Email
Diana.Kogan@sheba.health.gov.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eilon Ram, MD
Organizational Affiliation
Sheba Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sheba medical center
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diana Kogan
Phone
972-52-8646402
Email
Diana.Kogan@sheba.health.gov.il
First Name & Middle Initial & Last Name & Degree
Eilon ram, MD
Phone
972-54-4929101
Email
eilon.ram@sheba.health.gov.il

12. IPD Sharing Statement

Plan to Share IPD
No

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Impact of Anesthesia on the Dimension of the Ascending Aorta

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