Developing a Magnetic-POCUS-assisted Bronchoscopy in Difficult Endotracheal Intubation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- Time to success
研究概览
简要总结
Introduction Endoracheal intubation (ETI) is a crucial but risky procedure, especially among patients with suspected difficult endotracheal intubation (DTI). Bronchoscopy, as an improved technique commonly used in DTI, might encounters the difficulties of visualization. The magnetic point-of-care ultrasound (MGPOCUS) not only provide an novel visualization from outside, but also enable the estimation of relative position and trajectory of bronchoscopy. The study aims to evaluate the efficiency of MGPOCUS assisted bronchoscopy in time taken to the first-attempt success, the first-attempt and overall success of ETI, complications and satisfaction of visualization among patients suspected with DTI.
Methods and analysis The current study is a randomized, parallel-group, single-blinded, single-center study. Participants (n=350) will be recruited by primary anesthesiologist and randomized to groups of ETI with bronchoscopy or MGPOCUS assisted bronchoscopy. The primary outcome is time taken to the first-attempt success ETI. Secondary outcomes include procedure time, the first-attempt and overall success, complications and satisfaction of visualization. Cox regression with the Bonferroni correction and the linear mixed regression will be used to analysis the outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 18 and 85 years old.
- •Requiring ETI.
- •Anticipated DTI meets one or more positive findings in the airway evaluation, including history, examination, and appropriate investigations of anatomy .
- •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.
- •At risk of pulmonary or cardiovascular complications during intubation with flexible bronchoscope, including severe hypoxemia, severe pulmonary hypertension, unstable or severe obstructive airway disease.
- •At risk of bleeding during bronchoscope, including anticoagulants or coagulopathy, renal insufficiency, and superior vena cava syndrome.
- •High risk of aspiration.
- •Current pregnancy.
- •Patient unable to cooperate (for awake intubation).
研究组 & 干预措施
MGPOCUS-assisted bronchoscope-guided intubation
干预措施: MGPOCUS-assisted bronchoscope-guided intubation (Procedure)
Bronchoscope-guided Intubation
干预措施: Bronchoscope-guided intubation (Procedure)
结局指标
主要结局
Time to success
时间窗: At once after performing intubation at the first attempt and confirming successful endotracheal intubation by capnography
Time taken in seconds to successful intubation at the first-attempt
次要结局
- Procedure time(Whiler performing intubation.)
- The first-attempt success(At once after the first-attempt and confirmed by capnography..)
- Number of attempts(While performing the procedure)
- Overall success(At once after procedure and confirmed by capnography.)
- Satisfaction with visualizaiton(At once after every attempt before confirmed by capnography)
- Intubation relative complications(At once after performing procedure and after extubation.)