Estimation of Umbilical Venous Catheter Insertion Depth in Newborns Using Weight or Body Measurement: A Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Proportion of correctly inserted UVC at optimum catheter tip position
研究概览
简要总结
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.
详细描述
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:
- 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
- To compare the accuracy rate of UVC tip position between two methods based on growth status of neonates
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 1 Minute 至 2 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All infants who require UVC insertion as part of their routine care at anytime during their NICU admission
排除标准
- •Infants with hydrops fetalis, infants with abdominal wall defects, congenital diaphragmatic hernia and major structural heart disease
研究组 & 干预措施
UVC and surface measurement formula
UVC insertion depth = Umbilicus to nipple distance minus 1cm
干预措施: UVC (Device)
UVC and surface measurement formula
UVC insertion depth = Umbilicus to nipple distance minus 1cm
干预措施: Ultrasound (Device)
UVC and Birth weight based formula
UVC insertion depth=[(3× birth weight (Kg) + 9)/2+1)] cm
干预措施: UVC (Device)
UVC and Birth weight based formula
UVC insertion depth=[(3× birth weight (Kg) + 9)/2+1)] cm
干预措施: Ultrasound (Device)
结局指标
主要结局
Proportion of correctly inserted UVC at optimum catheter tip position
时间窗: within 12 hours
次要结局
- Number of readjustment of UVC(within first 2 weeks)
- Comparison of UVC tip position between two methods based on based growth status at birth (i.e.AGA, SGA, LGA)(within 12 hours)
研究者
Amuchou Soraisham
Associate Professor of Pediatrics
University of Calgary