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Not yet recruitingNCT07623330Updated Jun 22, 2026

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

An observational study in Peri Membranous Ventricular Septal Defect, sponsored by Ain Shams University. Not yet recruiting at 1 site in Egypt. Open to participants aged 6 Months to 5 Years. Per ClinicalTrials.gov, last updated 2026-06-22.

Sponsored by Ain Shams University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
115
Ages
6 Months to 5 Years
Sex
All
01

Study summary

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

Read the 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, the investigators 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.

02

Conditions studied

  • Peri Membranous Ventricular Septal Defect
03

In context

Lead sponsor

Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Months to 5 Years
Sexes eligible
All
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.

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
115 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

06

What researchers measure

Primary outcomes

  1. Accuracy of TEE-derived pressure gradient measurement across peri membranous VSD

    Accuracy of TEE derived Pressure gradient in numerical value across peri membranous VSD (in Rv inflow outflow view) in comparison with direct catheter-based measurements under general anesthesia.

    Time frame: intraoperative

Secondary outcomes

  1. Interrater agreement of TEE measurements

    Assessment of agreement between different operators with different levels of experience regarding TEE image acquisition and TEE derived measurements.

    Time frame: intraoperative

  2. Accuracy of TEE-derived RVSP and PASP measurements

    Comparison between TEE-derived RVSP/PASP and direct catheter-based measurements under general anesthesia.

    Time frame: intraoperative

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07623330
Lead sponsor
Ain Shams University
Responsible party
Sponsor
First posted
Jun 3, 2026
Start date
May 27, 2026 (estimated)
Primary completion
Jan 20, 2027 (estimated)
Completion
Apr 20, 2027 (estimated)
Last update
Jun 22, 2026

Study contacts

karim mohammad el kersh, MBBCH
Contact
karim.elkersh@med.asu.edu.eg
01002123494

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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