Use of TEE Derived Measurement vs Direct Measurement Under General Anesthesia in Assessment of Pressure Gradient in Peri Membranous Ventricular Septal Defect

In this study, we aim to compare the pressure gradient obtained by transesophageal echocardiography across the restrictive peri membranous VSD with direct catheter-based measurements of such gradient.

Study Overview

• Status: Not yet recruiting
• Conditions: Peri Membranous Ventricular Septal Defect

Detailed Description

Ventricular septal defect is the most common congenital heart defect, occurring in 50% of all children with congenital heart disease (CHD) and in 20% as an isolated lesion.

The peri membranous (also called Para membranous or Cono ventricular) VSD is a communication adjacent to a portion of the membranous septum and the fibrous trigone of the heart, where the, and tricuspid valves are in fibrous continuity. These infracristal defects (below the crista supra- ventricularis) are the most common VSD subtype, accounting for approximately 80% of VSDs.

The ventricular septum can be well imaged by TEE. Starting from the standard transverse plane at 0° or so in the mi esophageal four-chamber (ME 4-Ch) view, the crux of the heart, the inlet septum and most of the muscular trabecular septum can be well seen from the AV valves down to the apex.

In this study, we aim to compare the pressure gradient obtained by transesophageal echocardiography across the restrictive peri membranous VSD with direct catheter-based measurements of such gradient.

During the pre-anesthetic evaluation, demographic variables will be collected from each patient. ASA physical status and relevant comorbidities will be documented, and a recent echocardiogram will confirm the presence of VSD, its size, pressure gradient and estimated PAP.

Patients will be taken to the operating room and monitored with ASA standard monitors: ECG, NIBP, pulse oximetry, and capnography. Preoxygenation will be performed with FiO₂ adjusted to maintain normal oxygen saturation Anesthesia inhalational induction will be performed with sevoflurane until IV access is secured. Once IV access is established, transition to IV agents, fentanyl (1-2 mcg/kg), and rocuronium (0.8 mg/kg). Ventilation with oxygen and sevoflurane 1.5% for 3 min.

Direct laryngoscopy and intubation will be performed by an attending anesthesiologist (with more than two years of experience post-qualification) along with femoral arterial and venous line along with internal jugular central venous line insertion.

Using the previously inserted lines, the pressure gradient across VSD along with RVSP and PASP are directly measured using catheters under guidance of fluoroscopy along with the hemodynamics it was obtained with. This entails that this should be performed in a hybrid theatre otherwise, the confirmation of catheter placement by TEE should be done. TEE inserted in the same setup under the same hemodynamics, RV inflow outflow view obtained with best alignment for CWD interrogation and pressure gradient obtained along with its respective hemodynamics, this step is to be repeated with different personnel with different levels of experience. Care should be taken that both measurements should be taken with the same hemodynamics. TEE measurements of pressure gradient across the VSD are to be measured in the ME five chamber view and ME aorta long axis view as well.

The surgeon will then perform median sternotomy, cpb cannulation, VSD repair. Any considerable events during weaning from cpb shall be recorded along with the doses needed for vasopressors and inotropic support. TEE post bypass will be done by senior attending confirming VSD closure, RV function and PAP if possible.

• Study Type: Observational
• Enrollment (Estimated): 115

Contacts and Locations

• Study Contact: Name: karim mohammad el kersh, MBBCH; Phone Number: 01002123494; Email: karim.elkersh@med.asu.edu.eg

Study Locations

• Egypt
  • Abbasia
    • Cairo, Abbasia, Egypt, 00202
      • Ain Shams
      • Contact: karim mohammad el kersh, MBBCH; Phone Number: 01002123494; Email: karim.elkersh@med.asu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study will include pediatric patients aged 6 months to 5 years diagnosed with isolated peri membranous ventricular septal defect (VSD) who are scheduled for elective surgical VSD closure under general anesthesia. All patients will undergo intraoperative assessment of the pressure gradient across the VSD using both transesophageal echocardiography (TEE)-derived measurements and direct intraoperative measurement techniques.

Patients with other types of VSD, unrestrictive VSD, associated pulmonary vascular disease, recent or active upper respiratory tract infection, or any relative or absolute contraindication to TEE will be excluded. Informed consent will be obtained from legal guardians prior to enrollment.

Description

Inclusion Criteria:

• Pediatric patients (6 months to 5 years).
• Patients with isolated peri-membranous VSD.
• Scheduled for surgical VSD closure.

Exclusion Criteria:

• Refusal of legal guardians.
• Patients with other types of VSD.
• Patients with pulmonary vascular diseases.
• Patients with unrestrictive VSD.
• Recent or active upper respiratory tract infection.
• Any relative or absolute contraindication for TEE.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
TEE derived measurement vs direct catheter measurement; Pediatric patients with isolated peri membranous VSD undergoing surgical closure will undergo intraoperative pressure gradient assessment using both TEE-derived and direct catheter-based measurements under general anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of TEE-derived pressure gradient measurement across peri membranous VSD	Accuracy of TEE Pressure gradient across peri membranous VSD (in Rv inflow outflow view) in comparison with direct catheter-based measurements under general anesthesia.	intraoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Interrater agreement of TEE measurements	Assessment of agreement between operators with different levels of experience regarding TEE-derived measurements.	intraoperative
Accuracy of TEE-derived RVSP and PASP measurements	Comparison between TEE-derived RVSP/PASP and direct catheter-based measurements under general anesthesia.	intraoperative

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Estimated): May 27, 2026
• Primary Completion (Estimated): January 20, 2027
• Study Completion (Estimated): April 20, 2027

Study Registration Dates

• First Submitted: May 28, 2026
• First Submitted That Met QC Criteria: May 28, 2026
• First Posted (Actual): June 3, 2026

Study Record Updates

• Last Update Posted (Actual): June 3, 2026
• Last Update Submitted That Met QC Criteria: May 28, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: FMASU MD358/2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No