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

Recruiting

• Conditions: Aortic Regurgitation Disease; Aortic Insufficiency

• Registration Number: NCT06835946
• Lead Sponsor: University of Liege

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-14
• Study First Submitted QC: 2025-02-14
• Study First Posted: 2025-02-19
• Study Start: 2025-03-01
• Last Update Submitted: 2025-04-07
• Last Update Posted: 2025-04-10
• Primary Completion: 2027-03-01
• Study Completion: 2027-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Concordance between the grade of aortic regurgitation on pre-operative TTE and intra-operative TEE	From enrollment to the end of the pre-operative trans-esophageal echo	The preoperative TTE will be performed immediately before anesthesia induction. The intra-operative TEE will be performed after anesthesia induction.; Five measurements will be used to grade the aortic regurgitation including three major (vena contracta, ration between the width of the aortic regurgitation and the left ventricular outflow tract, and the pressure half time) and two minor (diastolic flow reversal in descending aorta and effective regurgitation orifice area assessed by the proximal isovelocity surface area method).; The images required to perform these measurements will be acquired three times on non contiguous cardiac cycles at end-expiration. The measurements will be performed offline, by two independent echocardiographers. Each of them will provide a mean for each measurement. The two means will be averaged for each criteria.

Secondary Outcome Measures

Name	Time	Method
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.	Enrollment to end of pre-operative trans-thoracic echo	The aortic regurgitation will be graded similarly as described for the primary outcome.

Trial Locations

Locations (1)

Centre Hospitalier Universitaire de Liège; 🇧🇪 Liège, Belgium