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NCT Number: NCT06835946

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

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.

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Key information

Conditions

Aortic Regurgitation Disease Aortic Insufficiency Aortic Valve Disease Aortic Valve Insufficiency Cardiovascular Diseases Heart Diseases Heart Valve Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier Universitaire de Liège

Liège, 4000, Belgium

Location status: Recruiting

Location contact

Alan Houven, MD

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

    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 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.

    Time frame: Enrollment to end of pre-operative trans-thoracic echo

    The aortic regurgitation will be graded similarly as described for the primary outcome.

Study contacts

Contact information is provided by the study sponsor or research team.

Alan Houven, MD

CONTACT

[email protected]

+3243237655

Sponsors and collaborators

Lead sponsor

University of Liege

Other

Registry information

Official study 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.

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Feb 19, 2025
Registry last updated
Apr 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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