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

NCT07623330 | Not Yet Recruiting DMC

• 1 other identifier: FMASU MD358/2025
• Study Type: observational
• Target: 115
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Peri Membranous Ventricular Septal Defect

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Interrater agreement of TEE measurements

  intraoperative

• Accuracy of TEE-derived RVSP and PASP measurements

  intraoperative

Study Arms (1)

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

Eligibility Criteria

• Age: 6 Months - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams

Cairo, Abbasia, 00202, Egypt

Location

Central Study Contacts

karim mohammad el kersh, MBBCH

CONTACT

01002123494; karim.elkersh@med.asu.edu.eg

Study Design

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

Study Record Dates

• First Submitted: May 28, 2026
• First Posted: June 3, 2026
• Study Start: May 27, 2026
• Primary Completion (Estimated): January 20, 2027
• Study Completion (Estimated): April 20, 2027
• Last Updated: June 3, 2026

Record last verified: 2026-05

Locations

EG (1)