Multi-center Evaluation of the NEMO Gauge to Aid in Correct Positioning of the Endotracheal Tube After Intubation of Critically Ill Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 6
- 主要终点
- Number of Correct Endotracheal Tube Position
研究概览
简要总结
The aim of this study is to verify the safety and accuracy of an FDA-approved device called the NEMO™ Gauge to aide in the proper positioning of the endotracheal tube (ETT), inserted in the lungs of patients admitted to the intensive care unit. The hope is that the NEMO™ Gauge is able to properly determine the correct position of the endotracheal tube without the use of a chest radiograph (chest x-ray). The study investigators anticipate sixty-eight (68) subjects will participate in this study at three (3) study centers in the Inland Empire of Southern California, with subjects being enrolled at Loma Linda University Medical Center, Riverside University Medical Center and Loma Linda Veterans Affairs Hospital.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Adult patients ≥ 18 years of age admitted to the intensive care unit (ICU)
- •Patients who have been intubated or at high risk of being intubated, requiring confirmation of ETT position after intubation as determined by the clinical team
- •Endotracheal tube size 7.0 mm to 8.5 mm in diameter
排除标准
- •Patients with active hemoptysis
- •Patients with known tracheal or bronchial masses prior to endotracheal intubation
- •Patients with known tracheal or bronchial abnormalities requiring surgical repair
结局指标
主要结局
Number of Correct Endotracheal Tube Position
时间窗: Immediate, post-intervention
The number of patients with correct Endotracheal tube position
次要结局
未报告次要终点
研究者
H. Bryant Nguyen
Professor of Medicine
Loma Linda University