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Impact of Anesthesia on the Dimension of the Ascending Aorta

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03431870
Recruitment Status : Recruiting
First Posted : February 13, 2018
Last Update Posted : April 8, 2021
Sponsor:
Information provided by (Responsible Party):
Sheba Medical Center

Study Description
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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
Aortic Aneurysm, Thoracic Other: Trans-esophageal echocardiography Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : January 21, 2018
Estimated Primary Completion Date : January 21, 2022
Estimated Study Completion Date : January 21, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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 Name: Cardiac surgery


Outcome Measures
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Primary Outcome Measures :
  1. difference in the aortic dimension [ Time Frame: intraoperative ]
    10% difference in the aortic dimension before and after anaesthesia


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03431870


Contacts
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Contact: Diana Kogan 972-52-8646402 Diana.Kogan@sheba.health.gov.il

Locations
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Israel
Sheba medical center Recruiting
Ramat Gan, Israel, 52621
Contact: Diana Kogan    972-52-8646402    Diana.Kogan@sheba.health.gov.il   
Contact: Eilon ram, MD    972-54-4929101    eilon.ram@sheba.health.gov.il   
Sponsors and Collaborators
Sheba Medical Center
Investigators
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Principal Investigator: Eilon Ram, MD Sheba Medical Center
More Information
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Responsible Party: Sheba Medical Center
ClinicalTrials.gov Identifier: NCT03431870    
Other Study ID Numbers: SHEBA-18-4459-ER-CTIL
First Posted: February 13, 2018    Key Record Dates
Last Update Posted: April 8, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Thoracic
 Vascular Diseases
Cardiovascular Diseases
Aortic Diseases