Impact of Anesthesia on the Dimension of the Ascending Aorta

Sponsor
Sheba Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT03431870
Collaborator
(none)
20
1
1
48
0.4

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Trans-esophageal echocardiography
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
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
Actual Study Start Date :
Jan 21, 2018
Anticipated Primary Completion Date :
Jan 21, 2022
Anticipated Study Completion Date :
Jan 21, 2022

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. difference in the aortic dimension [intraoperative]

      10% difference in the aortic dimension before and after anaesthesia

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sheba medical center Ramat Gan Israel 52621

    Sponsors and Collaborators

    • Sheba Medical Center

    Investigators

    • Principal Investigator: Eilon Ram, MD, Sheba Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sheba Medical Center
    ClinicalTrials.gov Identifier:
    NCT03431870
    Other Study ID Numbers:
    • SHEBA-18-4459-ER-CTIL
    First Posted:
    Feb 13, 2018
    Last Update Posted:
    Apr 8, 2021
    Last Verified:
    Apr 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 8, 2021