FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2023/03/050673 [Registered on: 14/03/2023] Trial Registered Prospectively
Last Modified On: 14/03/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [PROCEDURAL SUPERIORITY]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Study comparing how good an ultrasound scan guided long catheter insertion technique is in guiding the catheter to the correct position, when compared to the usual technique 
Scientific Title of Study   Comparison of accuracy of ultrasound guided umbilical venous catheter insertion with standard technique in neonates admitted in neonatal intensive care unit - a randomised controlled trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  NEETHU RAJEEV 
Designation  SENIOR PG REGISTRAR 
Affiliation  CHRISTIAN MEDICAL COLLEGE, VELLORE 
Address  ROOM NO 145, LADIES INTERNS QUARTERS, CHRISTIAN MEDICAL COLLEGE

Vellore
TAMIL NADU
632004
India 
Phone  9445732875  
Fax    
Email  neethurajeev1604@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  MANISH KUMAR 
Designation  PROFESSOR 
Affiliation  CHRISTIAN MEDICAL COLLEGE, VELLORE 
Address  DEPARTMENTOF NEONATOLOGY CHRISTIAN MEDICAL COLLEGE

Vellore
TAMIL NADU
632004
India 
Phone  9894853898  
Fax    
Email  maneeshdr@gmail.com  
 
Details of Contact Person
Public Query
 
Name  NEETHU RAJEEV 
Designation  SENIOR PG REGISTRAR 
Affiliation  CHRISTIAN MEDICAL COLLEGE, VELLORE 
Address  ROOM NO 145, LADIES INTERNS QUARTERS, CHRISTIAN MEDICAL COLLEGE


TAMIL NADU
632004
India 
Phone  9445732875  
Fax    
Email  neethurajeev1604@gmail.com  
 
Source of Monetary or Material Support  
FLUID RESEARCH GRANT - CHRISTIAN MEDICAL COLLEGE, VELLORE 
 
Primary Sponsor  
Name  FLUID RESEARCH GRANT 
Address  CHRISTIAN MEDICAL COLLEGE, VELLORE 632004 
Type of Sponsor  Private 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 MANISH KUMAR  CHRISTIAN MEDICAL COLLEGE   DEPARTMENT OF NEONATOLOGY, ISSCC BUILDING CHRISTIAN MEDICAL COLLEGE
Vellore
TAMIL NADU 
9894853898

maneeshdr@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL REVIEW BOARD, CMC VELLORE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 2||Placement,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Standard technique  Umbilical venous catheter insertion where depth of insertion is predetermined by Shuklas formula 
Intervention  Ultrasound  Umbilical venous catheter will be inserted under ultrasound guidance; if catheter advances in undesirable direction, pressure will be applied over the abdomen with ultrasound probe so as to guide the catheter towards the correct direction 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  28.00 Day(s)
Gender  Both 
Details  Neonates requiring umbilical venous catheter insertion as a part of their NICU care 
 
ExclusionCriteria 
Details  Suspected or diagnosed congenital diaphragmatic hernia
Suspected or diagnosed heterodoxy syndromes or situs inversus
hydrops foetalis
Babies requiring umbilical venous catheter insertion in labour room or operation theatre
Persistent pulmonary hypertension of newborn
 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Rate of accurate positioning of umbilical venous catheter tip in ultrasound guided group compared with standard group  Within 3 hours after catheter insertion 
 
Secondary Outcome  
Outcome  TimePoints 
Time taken for catheter insertion  At the time of catheter insertion 
Incidence of central line associated blood stream infection   Till the catheter is removed 
Incidence of extravasation  Till the catheter is removed 
 
Target Sample Size   Total Sample Size="112"
Sample Size from India="112" 
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)   03/04/2023 
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 Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Study will be published in an appropriate journal 7 potential authors  
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Umbilical venous catheters provide unique and easy central venous access in neonates. They are usually inserted based on a pre calculated depth of insertion. There are various methods to determine the depth of insertion. The position is confirmed with a radiograph. A common problem encountered with umbilical catheter insertion is catheter malposition. Malpositioned catheters are associated with various complications and warrant removal or repositioning.
In current practice, with the increasing availability of point of care ultrasound, it is also being used to localize catheter tips. In this study, we are evaluating an ultrasound-guided technique to prevent catheter malposition, specifically portal vein cannulation. We propose to compare the accuracy of ultrasound-guided catheter insertion 
versus standard  procedure. In this technique, UV catheter is inserted under ultrasound guidance. As the catheter is being inserted, the tip will be localized with an ultrasound probe kept over the abdomen. At the level of portal sinus, if the catheter is advancing to the portal vein, instead of ductus venosus, pressure will be applied over the abdomen with the ultrasound probe. This makes a change in the alignment of the venous system that the portal vein gets occluded and ductus venosus comes in line with the sinus, thus guiding the catheter into ductus venosus and then IVC.

We also propose to look at the time taken for catheter insertion and incidence of central line associated blood stream infection and extravasation associated with both techniques. This study may help in developing a bedside technique to accurately insert UVC, thus minimizing chance of catheter malposition.

 
Close