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临床试验/NCT07623330
NCT07623330尚未招募不适用

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

Ain Shams University1 个研究点 分布在 1 个国家目标入组 115 人开始时间: 2026年5月27日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
115
试验地点
1
主要终点
Accuracy of TEE-derived pressure gradient measurement across peri membranous VSD

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
6 Months 至 5 Years(Child)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.

研究组 & 干预措施

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

结局指标

主要结局

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

时间窗: intraoperative

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.

次要结局

  • Interrater agreement of TEE measurements(intraoperative)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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