| 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
|
|
|
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
|
|
|
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. |