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CTRI Number  CTRI/2025/05/087054 [Registered on: 16/05/2025] Trial Registered Prospectively
Last Modified On: 08/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   A Study on Using Ultrasound to Confirm Central Line Tip Placement in Children 
Scientific Title of Study   A Prospective Observational Study to Assess the Utility of Ultrasound for Central Venous Catheter Tip Placement in Children 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr. Apurva Kamat 
Designation  Junior Resident Doctor 
Affiliation  Lokmanya Tilak Municipal Medical College and Hospital 
Address  Department of Anaesthesiology, 4th Floor Lokmanya Tilak Municipal Medical College and Hospital, Sion, Mumbai

Mumbai
MAHARASHTRA
400022
India 
Phone  9158192265  
Fax    
Email  apurvakamat17@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Anila D Malde 
Designation  Professor and Head of the Department of Anesthesiology 
Affiliation  Lokmanya Tilak Municipal Medical College and Hospital 
Address  Room No. 424, 4th Floor, Department of Anaesthesiology, Lokmanya Tilak Municipal Medical College and Hospital, Sion, Mumbai.

Mumbai
MAHARASHTRA
400022
India 
Phone  9821085730  
Fax    
Email  dradmalde@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr. Apurva Kamat 
Designation  Junior Resident Doctor 
Affiliation  Lokmanya Tilak Municipal Medical College and Hospital 
Address  Department of Anaesthesiology, Lokmanya Tilak Municipal Medical College and Hospital, Sion, Mumbai

Mumbai
MAHARASHTRA
400022
India 
Phone  9158192265  
Fax    
Email  apurvakamat17@gmail.com  
 
Source of Monetary or Material Support  
Lokmanya Tilak Municipal Medical College and Hospital, Sion, Mumbai, Maharashtra, India. Pin- 400022 
 
Primary Sponsor  
Name  Lokmanya Tilak Municipal Medical College and Hospital 
Address  Lokmanya Tilak Municipal Medical College and Hospital, Sion, Mumbai, Maharashtra, India. Pin-400022 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Apurva Kamat  Lokmanya Tilak Municipal Medical College and Hospital Sion  Room No. 424 4th Floor Department of Anaesthesiology
Mumbai
MAHARASHTRA 
9158192265

apurvakamat17@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Human Research Lokmanya Tilak Municipal Medical College and General Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 4||Measurement and Monitoring,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  nil  nil 
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  12.00 Year(s)
Gender  Both 
Details  All paediatric patients aged 0-12 years requiring Central venous catheter placement for medical management. 
 
ExclusionCriteria 
Details  1) Patients with chest deformities and thick scars in whom subcostal bicaval view cannot be obtained.
2) Lack of parental consent. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Accurate placement of central venous catheter (CVC) tip at the superior vena cava (SVC)-right atrium (RA) junction using ultrasound   Baseline
Post procedure 
 
Secondary Outcome  
Outcome  TimePoints 
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.
3) To correlate the catheter insertion depth achieved using ultrasound guidance with the depth derived from height-based formulae.
4) To correlate the accuracy of central venous catheter (CVC) tip placement at the SVC-RA junction using ultrasound with that determined by chest radiograph.
 
Baseline
Post Procedure 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/07/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
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.

 
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