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

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.

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06835946

Enrollment

100

Registered

2025-02-19

Start date

2025-03-01

Completion date

2027-04-01

Last updated

2025-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Insufficiency, Aortic Regurgitation Disease

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Belgium

Contacts

Primary ContactAlan Houven, MD

ahouben@chuliege.be+3243237655

Outcome results