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Clinical Trials/CTRI/2025/05/087054
CTRI/2025/05/087054
Not yet recruiting
Not Applicable

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 site in 1 country30 target enrollmentStarted: July 1, 2025Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Lokmanya Tilak Municipal Medical College and Hospital
Enrollment
30
Locations
1
Primary Endpoint
Accurate placement of central venous catheter (CVC) tip at the superior vena cava (SVC)-right atrium (RA) junction using ultrasound

Overview

Brief Summary

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.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
0.00 Day(s) to 12.00 Year(s) (—)
Sex
All

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: Baseline | Post procedure

Secondary Outcomes

  • 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.)

Investigators

Sponsor
Lokmanya Tilak Municipal Medical College and Hospital
Sponsor Class
Government medical college
Responsible Party
Principal Investigator
Principal Investigator

Dr. Apurva Kamat

Lokmanya Tilak Municipal Medical College and Hospital

Study Sites (1)

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