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

NCT06835946 | Recruiting

• 1 other identifier: ANESTIAO
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Aortic Regurgitation Disease; Aortic Insufficiency

Outcome Measures

Primary Outcomes (1)

• Concordance between the grade of aortic regurgitation on pre-operative TTE and intra-operative TEE

  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.

  From enrollment to the end of the pre-operative trans-esophageal echo

Secondary Outcomes (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.

  Enrollment to end of pre-operative trans-thoracic echo

Study Arms (1)

Adult patients scheduled for cardiac surgery with previously known aortic regurgitation of any grade

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients scheduled for cardiac surgery at the "Centre Hospitalier Universitaire de Liège" with any grade of known preoperative aortic regurgitation.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Liege: lead

Study Sites (1)

Centre Hospitalier Universitaire de Liège

Liège, 4000, Belgium

RECRUITING

MeSH Terms

Conditions

Aortic Valve Insufficiency

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Alan Houven, MD

CONTACT

+3243237655; ahouben@chuliege.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2025
• First Posted: February 19, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: April 10, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)