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