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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-5
SponsorAin Shams University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Pediatric patients (6 months to 5 years).

Patients with isolated peri-membranous VSD.

Scheduled for surgical VSD closure.

Disqualifiers

Refusal of legal guardians.

Patients with other types of VSD.

Patients with pulmonary vascular diseases.

Patients with unrestrictive VSD.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

115 Participants
are grouped into 1 trial group
Group A: TEE derived measurement vs direct catheter measurement

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: