| 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
|
|
|
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
|
|
|
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. |