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临床试验/CTRI/2025/05/087054
CTRI/2025/05/087054尚未招募不适用

A Prospective Observational Study to Assess the Utility of Ultrasound for Central Venous Catheter Tip Placement in Children

Lokmanya Tilak Municipal Medical College and Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年7月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
Accurate placement of central venous catheter (CVC) tip at the superior vena cava (SVC)-right atrium (RA) junction using ultrasound

研究概览

简要总结

This prospective observational cohort study aims to evaluate the utility of ultrasound in accurately positioning central venous catheter (CVC) tips at the superior vena cava–right atrium (SVC-RA) junction in pediatric patients. Correct placement of the CVC tip is vital to avoid complications such as arrhythmias, valvular injury, or pericardial tamponade. Conventional methods such as chest radiography or insertion depth formulae are often limited by inaccuracy, radiation exposure, and procedural delays. Ultrasound, being real-time and radiation-free, has shown promise in adults, but there is limited data in pediatric populations. This study includes 30 children aged 0–12 years requiring CVC placement under anesthesia or sedation. Using sterile technique and Seldinger’s method, CVCs are inserted with ultrasound guidance, employing a subcostal bicaval view to visualize the SVC-RA junction and confirm catheter tip position. The rapid atrial swirl sign (RASS) is used to further confirm placement, and the quality of ultrasound visualization is graded. Initial insertion depth is calculated using height-based formulae and compared with ultrasound-confirmed depth and, where available, postoperative chest radiography using the tracheal bifurcation as a landmark. Parameters assessed include patient demographics, catheter specifications, insertion depth, visualization grade, guidewire position, RASS response, and radiographic tip location. Statistical analysis involves descriptive statistics, Pearson’s correlation, and Chi-square testing. The study seeks to establish whether ultrasound alone can ensure accurate CVC tip placement in pediatric patients, potentially reducing the need for confirmatory chest radiographs and enhancing patient safety by minimizing radiation exposure.

研究设计

研究类型
Observational

入排标准

年龄范围
0.00 Day(s) 至 12.00 Year(s)(—)
性别
All

入选标准

  • All paediatric patients aged 0-12 years requiring Central venous catheter placement for medical management.

排除标准

  • Patients with chest deformities and thick scars in whom subcostal bicaval view cannot be obtained.
  • Lack of parental consent.

结局指标

主要结局

Accurate placement of central venous catheter (CVC) tip at the superior vena cava (SVC)-right atrium (RA) junction using ultrasound

时间窗: Baseline | Post procedure

次要结局

  • 1) To assess the utility of rapid atrial swirl sign to detect the correct placement of the Central venous catheter (CVC) tip at the SVC-RA junction.(2) To assess the quality of view obtained by subcostal/subcostal bicaval view for visualisation of SVC-RA junction.)

研究者

发起方
Lokmanya Tilak Municipal Medical College and Hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr. Apurva Kamat

Lokmanya Tilak Municipal Medical College and Hospital

研究点 (1)

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