Umbilical Venous Catheter Insertion Depth in Neonates

Central Venous Catheterization Clinical Trial

Official title:

Estimation of Umbilical Venous Catheter Insertion Depth in Newborns Using Weight or Body Measurement: A Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02939690
• Other study ID #: 16-1303
• Status: Completed
• Phase: N/A
• Start date: October 2016
• Est. completion date: March 2018

Study information

• Verified date: May 2018
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 2 Weeks

Eligibility

Inclusion Criteria:

• All infants who require UVC insertion as part of their routine care at anytime during their NICU admission

Exclusion Criteria:

• Infants with hydrops fetalis, infants with abdominal wall defects, congenital diaphragmatic hernia and major structural heart disease

Related Conditions & MeSH terms

• Central Venous Catheterization

Intervention

Device:
• UVC
UVC insertion depth calculated by [(3× birth weight (Kg) + 9)/2+1)]
• UVC
UVC insertion depth calculated by umbilicus to nipple distance-1
• Ultrasound

Locations

Country	Name	City	State
Canada	Foothills Medical Center	Calgary	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Calgary

Country where clinical trial is conducted

Canada, 

References & Publications (6)

Dunn PM. Localization of the umbilical catheter by post-mortem measurement. Arch Dis Child. 1966 Feb;41(215):69-75. — View Citation

Gupta AO, Peesay MR, Ramasethu J. Simple measurements to place umbilical catheters using surface anatomy. J Perinatol. 2015 Jul;35(7):476-80. doi: 10.1038/jp.2014.239. Epub 2015 Jan 22. — View Citation

Harabor A, Soraisham A. Rates of intracardiac umbilical venous catheter placement in neonates. J Ultrasound Med. 2014 Sep;33(9):1557-61. doi: 10.7863/ultra.33.9.1557. — View Citation

Kieran EA, Laffan EE, O'Donnell CP. Estimating umbilical catheter insertion depth in newborns using weight or body measurement: a randomised trial. Arch Dis Child Fetal Neonatal Ed. 2016 Jan;101(1):F10-5. doi: 10.1136/archdischild-2014-307668. Epub 2015 A — View Citation

Michel F, Brevaut-Malaty V, Pasquali R, Thomachot L, Vialet R, Hassid S, Nicaise C, Martin C, Panuel M. Comparison of ultrasound and X-ray in determining the position of umbilical venous catheters. Resuscitation. 2012 Jun;83(6):705-9. doi: 10.1016/j.resus — View Citation

Shukla H, Ferrara A. Rapid estimation of insertional length of umbilical catheters in newborns. Am J Dis Child. 1986 Aug;140(8):786-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of correctly inserted UVC at optimum catheter tip position		within 12 hours
Secondary	Number of readjustment of UVC		within first 2 weeks
Secondary	Comparison of UVC tip position between two methods based on based growth status at birth (i.e.AGA, SGA, LGA)	AGA: appropriate for gestational age (i.e birth weight between 10th and 90th percentile for gestational age); SGA: Small for gestational age (i.e. birth weight <10th percetile for gestational age); LGA: large for gestational age (i.e.birth weight >90th percentile for gestational age) using Fentons growth chart for preterm infants and WHO growth chart for term infants	within 12 hours