| CTRI Number |
CTRI/2019/01/017282 [Registered on: 28/01/2019] Trial Registered Prospectively |
| Last Modified On: |
25/11/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [ultrasound] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Use of ultrasound to confirm position of catheters inserted through major blood vessels in newborn babies |
|
Scientific Title of Study
|
Use of Point of Care Ultrasound for Confirming Central Line Tip Position in Neonates |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anup Thakur |
| Designation |
Consultant Neonatologist, Sir Ganga Ram Hospital,New Delhi |
| Affiliation |
Sir Ganga Ram Hospital |
| Address |
Department of Neonatology
Sir Ganga Ram Hospital
Old Rajinder Nagar, New Delhi
Central
DELHI
110060
India |
| Phone |
8800565956 |
| Fax |
|
| Email |
dr.thakuranup@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anup Thakur |
| Designation |
Consultant Neonatologist, Sir Ganga Ram Hospital,New Delhi |
| Affiliation |
Sir Ganga Ram Hospital |
| Address |
Department of Neonatology
Sir Ganga Ram Hospital
Old Rajinder Nagar, New Delhi
Central
DELHI
110060
India |
| Phone |
8800565956 |
| Fax |
|
| Email |
dr.thakuranup@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anup Thakur |
| Designation |
Consultant Neonatologist, Sir Ganga Ram Hospital,New Delhi |
| Affiliation |
Sir Ganga Ram Hospital |
| Address |
Department of Neonatology
Sir Ganga Ram Hospital
Old Rajinder Nagar, New Delhi
Central
DELHI
110060
India |
| Phone |
8800565956 |
| Fax |
|
| Email |
dr.thakuranup@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Neonatology
Sir Ganga Ram Hospital
Old Rajinder Nagar
New Delhi-60 |
|
|
Primary Sponsor
|
| Name |
Sir Ganga Ram Hospital |
| Address |
Old Rajinder Nagar
New Delhi 60 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Anup Thakur |
Neonatal Intensive care unit,Department of Neonatology,Sir Ganga Ram Hospital |
Old Rajinder Nagar, New Delhi
Central
DELHI |
8800565956
dr.thakuranup@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee, Sir Ganga Ram Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P84||Other problems with newborn, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Point of care ultrasound |
After placement of central catheter, USG assessment of position of catheter tip will be done by the principal investigator. A radiograph will be performed to assess catheter position as the standard of care. For any chest radiograph of an infant with an upper extremity PICC, the arm will be positioned in a neutral 45â—¦ angle to the body midline axis. For a lower extremity PICC, the leg will be positioned in a relaxed, slightly flexed position. No manipulation of the central line will be done between USG and radiograph. The ultrasonologist will be blinded to the radiological findings.
Ultrasound will be done using Sonosite M Turbo machine with curvilinear probe with frequency of 8-4 MHz. A sub xiphoid right parasagittal view will be used to assess tip position of UVC, femoral venous lines and lower limb PICC, with additional complementary windows (long axis, apical, modified views) as needed. Once inferior vena cava (IVC) is visualized, probe head will be moved back and forth, until catheter tip can be clearly seen. For visualization of UAC, a sub xiphoid left parasagital view, high parasternal view and suprasternal view will be used with similar approach. Tip position of upper limb PICC will be assessed using the high parasternal view. If catheter tip is not visible using standard techniques, 0.5-1 ml of normal saline will be flushed through catheter to locate the tip.
|
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
30.00 Day(s) |
| Gender |
Both |
| Details |
All admitted neonates who would undergo central line placement. |
|
| ExclusionCriteria |
| Details |
1. Neonates with thoracic or abdominal congenital abnormalities.
2. Investigator not available.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Agreement between radiological and USG based assessment of central line tip position. |
At insertion of central lines |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. To assess the feasibility of USG for evaluation of tip position of central catheter in neonates. |
At insertion of central lines |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="65" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
11/02/2019 |
| Date of Study Completion (India) |
30/08/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Preterm and sick term infants frequently
require central venous access for provision of parenteral nutrition, infusion
of inotropes and other drugs. Many infants in addition may require
invasive central arterial canulation for blood pressure monitoring and repeated
blood sampling. Central lines in these infants are usually
inserted and advanced blindly to a predetermined length based on an external
anatomic measurement of the estimated catheter pathway. Optimality
of catheter tip position is confirmed with chest or abdominal radiographs.
Frequently, position of these catheters may be sub-optimal, necessitating
manipulation of catheters followed by further radiographs for reconfirmation. This involves handling of critically ill infants and carries a
significant risk of dislodgement of lines, radiation exposure and unacceptable
delay in confirmation of central catheter position.
Point of care ultrasound (USG) is an emerging
bedside tool in management of sick neonates. It may be used to locate catheter
position during and immediately after procedure, reducing the time lag and
radiation exposure. Its usefulness in placement of central lines in adults and
paediatric patients is well established. There are few studies
that have evaluated utility of USG in locating the tip position of central
catheters in neonates.We plan to conduct this study to assess
feasibility of USG for evaluation of tip position of central catheter in
neonates and to determine agreement between radiological and USG based
assessment of central line tip position. Objectives:
1. To
assess the feasibility of USG
for evaluation of tip position of central catheter in neonates.
2. To determine agreement between radiological
and USG based assessment of central line tip position.
|