Ultrasound-detectable Endotracheal Tube: a Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Proportion of the USD-ETTs visualized by ultrasound
研究概览
简要总结
The researchers are studying whether special features make it easier to see if the breathing tube is in the correct place. It is hoped that the investigational device will enable more accurate placement (depth and trachea vs. esophagus).
详细描述
The participant will have a breathing tube where the balloon (cuff) at the end of the tube has two special features: 1) The balloon will have a divot in it, rather than be round in shape, and 2) The balloon will be filled with saline (salt water), rather than air. The breathing tube is called an ultrasound detectable cuffed endotracheal tube (USD-ETT).
The USD-ETT has not been tested or used in humans previously.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
盲法说明
The outcomes assessor is "blinded" for outcome measure 4. Specifically the protocol says, "After each case is completed, the fluoroscopic images and ultrasound images will be interpreted by independent study team members who are blinded to the results of the other test."
入排标准
- 年龄范围
- 6 Months 至 42 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is undergoing scheduled or planned diagnostic or interventional cardiac catheterization with planned general anesthesia requiring endotracheal intubation.
排除标准
- •Patient has a known airway abnormality, including tracheal stenosis, previous tracheal stenosis, or tracheobronchomalacia.
- •Patient has a tracheostomy.
- •Patient is ventilator-dependent.
- •Patient has an anticipated difficult intubation based upon airway exam and/or history of difficult intubation.
- •Patient is unlikely (in opinion of anesthesia team) or is unable to be intubated with 3.5 mm, 4.0 mm, or 4.5 mm Inner Diameter USD-ETT due to the size of the patient or their airway.
- •Patient is already intubated prior to the scheduled procedure.
- •It is anticipated that the patient will not be extubated after the catheterization procedure.
- •Concurrent enrollment in another clinical trial with an intervention during the cardiac catheterization procedure or 30 days afterwards.
- •Allergy to plastic/materials in USD-ETT
研究组 & 干预措施
Ultrasound detectable cuffed endotracheal tube (USD-ETT)
Intubation with a novel ultrasound-detectable endotracheal tube
干预措施: Ultrasound detectable cuffed endotracheal tube (USD-ETT) (Device)
结局指标
主要结局
Proportion of the USD-ETTs visualized by ultrasound
时间窗: Within 5 minutes of placing the ultrasound probe at the suprasternal notch after intubation
Reported as a 'yes' or 'no' - this outcome simply seeks to verify if the ultrasound can detect the ultrasound detectable cuffed endotracheal tube. The outcome measure assesses if the device is detectable as designed. It does not assess health related information.
次要结局
- Safely support ventilation and oxygenation of the patient during the procedure(Immediately following extubation)
- Kappa agreement between placement location of USD-ETT as assessed by ultrasound and fluoroscopy(Approximately 5 minutes after of placing the ultrasound probe at the suprasternal notch after intubation)
- Adverse events that could be related to the USD-ETT device(Up to 30 days post intubation)
研究者
John R. Charpie
Professor of Pediatric Cardiology, Professor of Pediatrics
University of Michigan