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 volunteersQualifiers
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
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Interrater agreement of TEE measurements
Assessment of agreement between different operators with different levels of experience regarding TEE image acquisition and TEE derived measurements.
Accuracy of TEE-derived RVSP and PASP measurements
Comparison between TEE-derived RVSP/PASP and direct catheter-based measurements under general anesthesia.
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: