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临床试验/NCT03954977
NCT03954977已完成不适用

Point of Care Ultrasound for PICC Line Monitoring Study

Seattle Children's Hospital4 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年2月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
4
主要终点
PICC line tip is located by the ultrasound operator

研究概览

简要总结

A prospective comparative study evaluating chest x-ray determination of PICC line tip location and POC ultrasound PICC line tip location. NICU patient's with PICC lines will be enrolled and blinded ultrasound operators will scan the neonate to find the PICC tip location. This will be compared to the location on the patient's chest x-ray. This process will be repeated each time the patient has a chest x-ray.

详细描述

Point of care (POC) ultrasound has become an invaluable tool for critically ill children. Several studies have been completed detailing its use for central line access and determining the location of the tip of umbilical venous lines. There are no current studies on monitoring PICC line tip placement using POC ultrasound. There have been studies showing ultrasound can be used to locate PICC line tip location, but none for monitoring. A previous study found that the sensitivity and specificity of US in identifying the location of PICC line tip were 86% and 75% respectively.

Review of the literature notes that Costa et al also found a high rate of PICC line complications. Costa et al and the investigators local experience also highlight the rare but potentially fatal complication of pericardial effusion from PICC lines that are too deep in the heart. One way the investigators could improve the safety of neonatal PICC lines is monitor them more closely. Current standard of care is to monitor PICC line tips on chest x-ray. Unfortunately, there is strong evidence that chest x-ray does not accurately identify the PICC line tip location. Another way would be to use POC ultrasound. A literature review on POC ultrasound to determine the location of a PICC line tip revealed that no such study has been done. Several studies have been completed demonstrating POC ultrasound both improved success rate and time to confirmation of placement of PICC lines.3 Pulickal et al published data on teaching pediatric residents to do point of care ultrasound to determine the location of the UVC tip. The investigators in that study found the residents were not only better at determining the correct location than chest x-ray, but the procedure was well tolerated. The investigators for this study feel further evaluation of POC ultrasound for PICC line tip monitoring to determine feasibility and accuracy is needed.

Eligible patients will be identified by the NICU care team. Participants will then be consented for the study by the study team. Trained Neonatology Fellows/Attendings will perform POC ultrasound to identify and document the PICC tip location and will be blinded to the PICC line tip location on x-ray. Ultrasounds will only be performed during patient's care times and be limited to 15 minutes.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Screening
盲法
None

盲法说明

Investigator is blinded to xray result before doing ultrasound

入排标准

年龄范围
— 至 12 Months(Child)
性别
All
接受健康志愿者

入选标准

  • NICU patient at Seattle Childrens Hospital or University of Washington
  • Patient has a PICC line in place

排除标准

  • vertebral anomalies
  • anomalies of venous anatomy
  • tracheal anomalies.

研究组 & 干预措施

Ultrasound vs Radiograph

Experimental

NICU patient's with PICC lines will be enrolled and blinded ultrasound operators will scan the neonate to find the PICC tip location. This will be compared to the location on the patient's chest x-ray. This process will be repeated each time the patient has a chest x-ray.

干预措施: PICC line ultrasound (Diagnostic Test)

结局指标

主要结局

PICC line tip is located by the ultrasound operator

时间窗: 6 months

PICC line identified under ultrasound

次要结局

  • PICC line location on ultrasound agrees with radiograph(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Patrick Motz

Neonatal Perinatal Fellow

Seattle Children's Hospital

研究点 (4)

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