Gastric Ultrasound Feeding Tube Placement Confirmation Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Test effectiveness of ultrasound in determining gastric feeding tube position in stomach.
研究概览
简要总结
Objective
This study aims to assess the accuracy and reliability of ultrasound in determining the correct placement of gastric feeding tubes (GFTs) in intensive care patients.
Study Design
A diagnostic study will be conducted to evaluate the efficacy of ultrasound in determining GFT placement in all ICU patients who require GFT placement. Patients will undergo ultrasound by an ultrasonographer (USG) after receiving a new or replaced GFT. The USG will assess the presence or absence of a "mosaic sign" after insufflation of 20 mL of air through the GFT. The mosaic sign indicates proper GFT placement in the stomach.
Methods
All ultrasonographic measurements will be recorded and saved in a central picture archiving and communication system (PACS). The images will be labeled with the deepness of the GFT (20 cm, 50 cm, or tracheobronchial) and anonymized before being presented to an intensivist expert in USG for interpretation.
Hypothesis
A 20 mL air insufflation via a GFT at the esophageal level or via a suction catheter in the tracheobronchial system will not produce a "mosaic sign" on ultrasound. This sign will only be present if the GFT is properly positioned in the stomach.
详细描述
Objective: To evaluate the effectiveness of ultrasound Doppler in determining the correct placement of gastric feeding tubes (GFTs) in intensive care patients compared to the standard of care, chest X-ray (CXR).
Study Design: A diagnostic study involving ICU patients who require GFT placement or replacement.
Background: Misplacement of GFTs is a common complication in ICU settings, with significant potential consequences for patient safety. Ultrasound Doppler has emerged as a potential alternative to CXR for confirming GFT placement due to its portability, ease of use, and real-time assessment.
Methods:
Subject Selection: Subjects will be recruited from the ICU at the Leiden University Medical Center (LUMC) who meet the inclusion criteria: tracheally intubated, require GFT placement or replacement, and provide informed consent.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Being tracheally intubated
- •Have a gastric feeding tube which needs replacement for any particular reason e.g the GFT is not functioning, has been displaced, and the patient has no exclusion criteria ( zie 4.3).
- •Need a gastric feeding tube
- •Given informed consent directly
排除标准
- •Does not need a gastric feeding tube and doesn't have one.
- •Laparotomy wound interfering with abdominal ultrasound.
- •Patient in prone position
- •No informed consent
结局指标
主要结局
Test effectiveness of ultrasound in determining gastric feeding tube position in stomach.
时间窗: ultrasound control of gastric feeding tube, confirming with X-ray
To assess the effectiveness of the test we will calculate its sensitivity and specificity. Sensitivity in this case being the proportion of images categorized as having a "mosaic sign present" by the blinded intensivist and indeed representing a gastric GFT localisation (objectivized by CXR). Specificty being the proportion of images categorized as "mosaic sign absent" and representing a non-gastric GFT localisation ( Air insuflation at 20cm GFT insertion and in tracheal canula (TB)). Sensitvity and Specificity will be expressed as a percentage as well as false positive and false negative rates. With this information we will be able to calculate the Likelihood Ratio (LR) for a positive result and for a negative result. The analysis will be done using the statistical program SPSS.
次要结局
- Correlating results with basline patient demographic, ventilator settings and post procedure chest x-ray findings.(baseline and post procedure ( gastric feeding tube) chest x-ray)
研究者
jelopezmatta
Medical Doctor
Leiden University Medical Center