跳至主要内容
临床试验/NCT04795895
NCT04795895终止不适用

Ultrasound for Confirmation of Gastric Tube Placement in Critically Ill Patients Under Invasive Mechanical Ventilation, a Randomization Trial

National Taiwan University Hospital2 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2021年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
62
试验地点
2
主要终点
correct rate as comparing with the chest radiography in each group

研究概览

简要总结

Introduction: Data using ultrasonography to confirm correct position of the gastric tube is heterogeneous in approach sites, combination exams, and methodology.

Aim: Find the best strategy to confirm gastric tube placement to avoid immediate complication.

Method: A randomized controlled trial was initiated to compare ultrasonography and standard routine method, using non-inferiority design. The study will be conducted in one medical ICU with 59 beds at a medical center. The primary outcome is the correct rate as comparing with the chest radiography in each group. Total 190 patients is needed with estimated 10% drop-out rate.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Care Provider)

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical indication of nasogastric tube placement
  • Age than 20 years old.
  • Exclusion criteria:
  • Facial trauma or head-base fractures
  • Esophageal or gastric resection
  • Esophageal strictures or alkaline injury
  • Open wound in the area to prevent ultrasonography

排除标准

  • 未提供

结局指标

主要结局

correct rate as comparing with the chest radiography in each group

时间窗: 1 day

次要结局

  • procedure time, tube placement confirmation time other than chest radiography method, and additional auscultation method in US group(1 day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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