Aortic Aneurysm, ThoracicNCT03431870
Impact of Anesthesia on the Dimension of the Ascending Aorta
A study testing Trans-esophageal echocardiography in people with Aortic Aneurysm, Thoracic, run by Sheba Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Aortic Aneurysm, Thoracic
- What is being tested?
- Trans-esophageal echocardiography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- 21 Jan 2018to 21 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ascending aorta of 40 mm and above
- Patients who undergo cardiac surgery
Who cannot join
- Unstable patients
- Patients who underwent a previous cardiac surgery
- Patients who were diagnosed with aortic dissection
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Sheba medical center
Ramat Gan, 52621
Diana Kogan, 972-52-8646402, Diana.Kogan@sheba.health.gov.il
Eilon ram, MD, 972-54-4929101, eilon.ram@sheba.health.gov.il
About this study
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
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.
Read the 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.
- Conditions
- Aortic Aneurysm, Thoracic
- Being tested
- Trans-esophageal echocardiography
- Medical subject headings
- Aortic Aneurysm, Thoracic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trans-esophageal echocardiographyOther
Also called Cardiac surgery
Perform a trans-esophageal echocardiography before and after anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Aorta dilated | Other | Patients with aorta of 40mm or more who undergo a cardiac surgery. The intervention include: Trans-Esophageal Echocardiography Receives: Other: Trans-esophageal echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
difference in the aortic dimension
10% difference in the aortic dimension before and after anaesthesia
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2018
- Study start21 Jan 2018
- Primary completion21 Jan 2022 (estimated)
- Study completion21 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Aneurysm, ThoracicStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Eilon Ram, MD, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03431870
- Sponsor's protocol ID
- SHEBA-18-4459-ER-CTIL
- Status last verified
- Apr 2021
- First submitted
- 23 Jan 2018
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03431870
- Acronym / sponsor ID
- SHEBA-18-4459-ER-CTIL
- Conditions
- Aortic Aneurysm, Thoracic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- 21 Jan 2018 (actual)
- Primary completion
- 21 Jan 2022 (estimated)
- Study completion
- 21 Jan 2022 (estimated)
- First posted
- 13 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aorta dilated | Other | Other: Trans-esophageal echocardiographyPatients with aorta of 40mm or more who undergo a cardiac surgery. The intervention include: Trans-Esophageal Echocardiography |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Ascending aorta of 40 mm and above
- Patients who undergo cardiac surgery
Key exclusion criteria (3 listed)
- Unstable patients
- Patients who underwent a previous cardiac surgery
- Patients who were diagnosed with aortic dissection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trans-esophageal echocardiographyAlso: Cardiac surgeryPerform a trans-esophageal echocardiography before and after anesthesia. | Other | Aorta dilated |
Primary outcome
difference in the aortic dimension
Time frame: intraoperative
10% difference in the aortic dimension before and after anaesthesia
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
- Individual participant dataSharing planned: No
Related trials for Aortic Aneurysm, Thoracic
Recruiting
Treatment in Thoracic Aortic Aneurysm: Surgery vs Surveillance
Ascending Aortic Aneurysm Enlargement, Ascending Aorta Aneurysm
Recruiting
GORE® TAG® Thoracic Branch Endoprosthesis Zone 0/1 Post-Approval Study
Aortic Arch Dissection, Aortic Arch Aneurysm
RecruitingPhase 4
Effect of Remimazolam Versus Propofol Total Intravenous Anesthesia on Intraoperative Hemodynamic Stability in Patients Undergoing Thoracic or Abdominal Endovascular Aortic Repair
Aortic Aneurysm, Thoracoabdominal, Aortic Aneurysm, Abdominal
Not yet recruitingPhase 4
Effects of Remimazolam on Postoperative Cognitive Dysfunction and Neuroinflammatory Biomarkers in Patients Undergoing Aortic Arch Surgery
Aortic Aneurysm of the Proximal Arch, Aortic Aneurysms Arch
Enrolling by invitation
Endovascular Treatment of Thoracic Aortic Disease
Thoracic Aortic Aneurysms, Dissecting, Aneurysm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eilon Ram, MD principal investigator
Sheba Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trans-esophageal echocardiography in people with Aortic Aneurysm, Thoracic, run by Sheba Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Diana Kogan (972-52-8646402, Diana.Kogan@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
difference in the aortic dimension (time frame: intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2021.