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Recruiting NCT06835946

Impact of Anesthesia, Positive Pressure Ventilation and Modality of Imaging on the Echocardiographic Assessment of the Severity of Aortic Regurgitation

Observational Aortic Regurgitation Disease Aortic Insufficiency

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Aortic Regurgitation Disease, Aortic Insufficiency. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Prospective Single-center Observational Trial Aimed at Investigating the Effect of General Anesthesia, Positive Pressure Ventilation and Change of Imaging Modality From Transthoracic Echo to Transesophageal Echo on the Grading of the Severity of Aortic Regurgitation.

Overview

The goal of this observational study is to assess the impact of imaging modality (trans-thoracic echo (TTE) vs trans-esophageal echo (TEE)), anesthesia and positive pressure ventilation on the grading of aortic insufficiency. Patients scheduled for cardiac surgery and in whom a TEE is going to be performed intra-operatively will be enrolled. The grading of the aortic insufficiency will be compared between a TTE performed immediately before the induction of general anesthesia end the TEE performed after induction of general anesthesia.

Primary outcome measures

  • Concordance between the grade of aortic regurgitation on pre-operative TTE and intra-operative TEE [Time frame: From enrollment to the end of the pre-operative trans-esophageal echo]
Secondary outcome measures (1)
  • Concordance between the grade of aortic regurgitation based on the pre-operative trans-thoracic echo and a trans-thoracic echo repeated immediately after induction of anesthesia. [Time frame: Enrollment to end of pre-operative trans-thoracic echo]

Eligibility criteria

Inclusion criteria

  • Known aortic regurgitation of any grade
  • Scheduled for a cardiac surgery procedure during which a trans-esophageal echo is planned.

Exclusion criteria

  • Non sinus rhythm
  • Mitral regurgitation more than mild.
  • Pre-operative critical state (according to the definition of the EuroSCORE II)
  • Presence of a prosthetic aortic valve
  • Contra-indication to trans-esophageal echo

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Belgium · 1 center
  • Centre Hospitalier Universitaire de Liège — Liège

Identifiers

NCT: NCT06835946 · ANESTIAO

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗