| CTRI Number |
CTRI/2025/08/092579 [Registered on: 07/08/2025] Trial Registered Prospectively |
| Last Modified On: |
06/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of two methods for finding the right depth for neck vein catheter in children |
|
Scientific Title of Study
|
Comparison of topography with TEE derived formula for optimum depth of insertion of right internal jugular vein catheter in pediatric patients |
| 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 Yukta Singh |
| Designation |
Post Graduate Resident |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung hospital |
| Address |
Department of Anaesthesia and Intensive Care, Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi-110029
South
DELHI
110029
India |
| Phone |
8826169647 |
| Fax |
|
| Email |
yuktasings.28@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepti Saigal |
| Designation |
Professor |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung hospital |
| Address |
Department of Anaesthesia and Intensive Care, Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi-110029
South
DELHI
110029
India |
| Phone |
8595611255 |
| Fax |
|
| Email |
deeptisaigal21@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepti Saigal |
| Designation |
Professor |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung hospital |
| Address |
Department of Anaesthesia and Intensive Care, Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi-110029
DELHI
110029
India |
| Phone |
8595611255 |
| Fax |
|
| Email |
deeptisaigal21@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia and Intensive Care Vardhman Mahavir Medical College and Safdarjung hospital New Delhi 110029 |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesia and Intensive Care |
| Address |
Vardhman Mahavir Medical College and Safdarjung hospital New Delhi 110029 |
| 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 Yukta Singh |
Safdarjung Hospital |
Department of Anaesthesia and Intensive Care,Vardhman Mahavir Medical College and Safdarjung hospital New Delhi 110029
South
DELHI |
8826169647
yuktasings.28@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Safdarjung Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Insertion of central venous catheter in right Internal Jugular vein at depth calculated by TEE derived formula method |
Insertion of central venous catheter in right Internal Jugular vein in pediatric patients under ultrasound guidance after induction of general anaesthesia with the catheter being fixed at a depth as calculated by TEE derived formula method |
| Intervention |
Insertion of central venous catheter in right Internal Jugular vein at depth calculated by topographic method |
Insertion of central venous catheter in right Internal Jugular vein in pediatric patients under ultrasound guidance after induction of general anaesthesia with the catheter being fixed at a depth as calculated by topography method . |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
All patients requiring insertion of right internal jugular vein central venous catheter. |
|
| ExclusionCriteria |
| Details |
Coagulopathy, Infection at local site, Presence of arrythmias, Deformity of neck(scars, mass etc.) or chest (barrel chest, pigeon chest) |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of optimum depth of insertion of right internal jugular vein catheter |
18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Need for repositioning |
assessed immediately after insertion of catheter |
| Incidence of arrythmia |
assessed immediately after insertion of catheter |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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)
|
25/08/2025 |
| 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="6"
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 trial is a randomized, single blind, parallel group trial being conducted at a single centre in India in having a sample size of 62.The primary objective of the study is to compare the topography method with TEE derived formula method for the incidence of optimum depth of insertion of right internal jugular vein central venous catheter using chest radiograph in pediatric patients and secondary objectives include access time, guidewire time, incidence of arrhythmias while insertion and incidence of repositioning of central venous catheter. |