Central Venous Catheterization Clinical Trial
Official title:
Estimation of Umbilical Venous Catheter Insertion Depth in Newborns Using Weight or Body Measurement: A Randomized Trial
In this randomized clinical study, neonates who require umbilical venous catheter (UVC) insertion as part of their routine care at anytime during their NICU admission will be randomized to one of the 2 formulas for estimation of the pre-insertion UVC depth (umbilicus to the nipple in cm minus 1 (UN - 1) or birth weight based formula ([(3× birth weight (Kg) + 9)/2+1)]. UVC will be inserted under sterile condition as per unit protocol. To verify the UVC tip position, a thoracoabdominal radiograph will be taken. In addition, the investigators will do a ultrasound of the heart to assess the exact location of the catheter tips as soon as possible but within 6 hours of insertion.
Background:
The ideal position of UVC) tip to minimize complications is just outside the heart at the
junction of inferior vena cava and right atrium. UVC related complications are mainly due to
catheter malposition. Accurate prediction of insertion length of UVC as well as confirmation
of the position after insertion by radiograph or with ultrasound is very important to avoid
complications. UVC malposition with subsequent re-positioning exposes these fragile infants
to unnecessary handling, further radiologic exposure and increasing risk of infection.
The commonly used formulas to estimate the depth of umbilical catheter include Dunn's
shoulder to umbilical length graph and a birth weight based formula proposed by Shukla and
Ferrara in 1986. In Calgary, the most commonly used method for estimation of UVC insertion
length is the birth weight based formula (i.e. UVC insertion length = (3 x birth weight +
9)/2 +1). The success rate of achieving the optimum position of catheter tip using this
formula ranges from 31-40%. A recent retrospective study reported the use of different
surface markers for calculating UVC insertion depth. A distance from base of umbilicus to
nipple distance (UN)-1 cm provided the best and most accurate insertion depth of UVC. This
formula had accuracy rate of 84% compared with 57% accuracy rate with birth weight based
formula.
The objectives of our study are:
1. To compare accuracy rate between UVC insertion length estimated by using two formula
(i.e. umbilicus to the nipple distance in cm minus 1 (UN - 1) and Shukla's birth weight
based formula ([(3× birth weight (Kg) + 9)/2+1)] in achieving optimum UVC tip position
2. To compare the accuracy rate of UVC tip position between two methods based on growth
status of neonates
Methods:
This is a randomized clinical study. All infants who require UVC insertion as part of their
routine care at anytime during their hospital admission are eligible for the study. Infants
with hydrops fetalis, abdominal wall defects, congenital diaphragmatic hernia and/or major
structural heart disease will be excluded from the study.
When a newborn baby needs UVC central line insertion, neonate will be randomized to one of
the 2 formulas for estimation of the pre-insertion UVC depth. UVC will be inserted under
sterile condition as per unit protocol. To verify the UVC tip position, a thoracoabdominal
radiograph will be taken. In addition,the investigators will do a ultrasound of the the heart
to assess the exact location of the catheter tips as soon as possible but within 6 hours of
insertion.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02741453 -
Bilateral Internal Jugular Veins Ultrasound Scanning Prior to CVC Placement
|
N/A | |
Completed |
NCT02661607 -
Point of Care Echocardiography Versus Chest Radiography for the Assessment of Central Venous Catheter Placement
|
N/A | |
Not yet recruiting |
NCT03442790 -
Agitated Saline Versus CXR Confirmation of Central Venous Lines
|
N/A | |
Not yet recruiting |
NCT04279808 -
Adequate Insertion Depth of Dilator During Central Venous Catheterization
|
N/A | |
Completed |
NCT01003366 -
Effect of the Bevel Direction of Puncture Needle on Success Rate and Complications During Central Venous Catheterization
|
N/A | |
Completed |
NCT03841968 -
Dynamic SAX vs Conventional LAX in Internal Jugular Vein Catheterization
|
N/A | |
Completed |
NCT01543360 -
Comparison of Axillary Versus Subclavian Vein Strategies for Central Venous Catheterization Under Continuous Ultrasound Guidance
|
N/A | |
Withdrawn |
NCT03348826 -
Study of Sodium Bicarbonate in Restoring Blocked Catheters
|
Phase 2 | |
Recruiting |
NCT04962945 -
Comparison of the Oblique-axis and Long-axis Approaches for Axillary Vein Catheterization Under Ultrasound Guidance
|
N/A | |
Not yet recruiting |
NCT06469034 -
Mixed Reality and Head-mounted Display for Central Venous Catheterization
|
N/A | |
Completed |
NCT04690296 -
Ultrasound Guidance Versus Anatomical Landmarks for Subclavian Vein Catheterization
|
N/A | |
Not yet recruiting |
NCT02264964 -
Duration and Adverse Events of Non-cuffed Catheter in Patients With Hemodialysis
|
N/A | |
Recruiting |
NCT06050902 -
Standard Ultrasound Guidance vs. New Needle-steering Device in Subclavian Venous Catheterization
|
N/A | |
Completed |
NCT03395691 -
Comparison of the Proximal Approach and Distal Approach of Axillary Vein Catheterization Under Ultrasound Guidance
|
N/A | |
Completed |
NCT03741946 -
Contralateral Head Rotation on Internal Jugular Vein to Carotid Artery Distance and Overlap Ratio
|
N/A | |
Not yet recruiting |
NCT04916288 -
Needle Puncture Point During Central Venous Catheterization With Ultrasound Guidance
|
||
Recruiting |
NCT05409768 -
Comparison of Two Approach in Ultrasound Guided Central Venous Catheterizations
|
N/A | |
Not yet recruiting |
NCT06375252 -
Evaluation of Central Jugular Vein Catheter Lumen Holder Design and Ergonomic Use
|
N/A |