Real-time Sonography as an Auxiliary Approach to Detect Inadvertent Esophageal Intubation Before Ventilation Among Suspected Difficult Intubation Patients: a Randomized Control Study
试验速览
- 阶段
- 不适用
- 入组人数
- 278
- 主要终点
- The specificity.
研究概览
简要总结
Early detection of esophageal intubation, one of the most common complications while performing endotracheal intubation (ETI), is crucial to adequate airway management, especially among patients suspected of difficult intubation (DI). Detective approaches with ventilation require time, increase the risk of emesis and aspiration to patients, and increase the risk of particle aerosolization to health providers under the epidemic of aerosol-borne diseases. Our study will determine the effectiveness of real-time sonography assisted to direct visualization to detect esophageal intubation before ventilation among DI patients.
详细描述
A single-blind, superiority, randomized controlled study. 224 eligible participants requiring elective orotracheal intubation under general anesthesia with suspected DI will be randomized 1:1 to sonography and direct visualization versus direct visualization alone. The primary objective will be to investigate, in suspected DI patients, if the real-time sonography-assisted with direct visualization results in improved specificity in the detection of inadvertent esophageal intubation before ventilation compared with direct visualization while performing intubation. The secondary objectives will be to compare the sensitivity, positive likelihood ratio (LR+), negative likelihood ratio (LR-), diagnostic odds ratio (DOR), positive predictive value (PPV), negative predictive value (NPV), and detective self-confidence grade using sonography-assisted direct visualization vs direct visualization. Test characteristics will be calculated using standard formulas for a binomial proportion, and the corresponding 95% confidence intervals (CIs), by the Wilson interval method.
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 (Participant)
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
- •Aged above 18 years old.
- •Requiring elective orotracheal intubation under general anesthesia in the OR.
- •Suspected DI according to airway assessments ，and with low risk of difficult ventilation.
- •Planning to use a Macintosh laryngoscope blade on the first attempt, whether direct or video laryngoscopy.
- •Signed written informed consent.
- •Willingness for the primary anesthesia team to participate.
排除标准
- •Anterior neck lesions, masses, lacerations, or subcutaneous emphysema.
- •A history of neck operation or tracheotomy.
- •Allergies to ultrasound coupling gel.
结局指标
主要结局
The specificity.
时间窗: Upon or within three minutes of performing intubation.
The detected negative/ true negative. According to the purpose of the proposed study, we will define esophageal intubation as positive, and endotracheal intubation as negative. In group direct visualization, positive and negative are defined as absent and present visualization of the tracheal tube passing through the glottis, respectively. In group ultrasonography assisted direct visualization, positive is defined as sonography detection of esophageal dilation or "double-tract" sign, and negative is defined as direct visualization of the tracheal tube passing through the glottis. If neither the specific US nor the clear visualization is noted, the intubator and the sonographer will discuss and reach a consistent conclusion in three seconds.
次要结局
- The positive predictive value.(Upon or within three minutes of performing intubation.)
- The positive likelihood ratio.(Upon or within three minutes of performing intubation.)
- The diagnostic odds ratio.(Upon or within three minutes of performing intubation.)
- The detective self-confidence grade(Upon or within three minutes of performing intubation.)
- The negative likelihood ratio.(Upon or within three minutes of performing intubation.)
- The sensitivity.(Upon or within three minutes of performing intubation.)
- The negative predictive value(Upon or within three minutes of performing intubation.)
研究者
Tian Yuan, MD
Physician
Peking Union Medical College Hospital