Suction Catheter as a Guide for Nasotracheal Intubation Under General Anesthesia: Randomized Clinical Trial of Efficacy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Extent of Bleeding
研究概览
简要总结
The goal of this clinical trial to study the efficacy of suction catheter guided technique and conventional technique during nasotracheal intubation.
The main question are
- How effective of the use of a suction catheter guided ETT in reducing bleeding during nasotracheal intubation?
- Does the use of a suction catheter guided ETT can improve its navigability through the nasal passage and reduce nasal passage time?
详细描述
Study design Clinical trial: Prospective randomized controlled trial with equal randomization (1:1), double-blinded (Participant and Primary outcome assessor), parallel design
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient undergoing elective oral and maxillofacial surgery in which nasotracheal intubation is preferred over orotracheal intubation to optimize surgical access.
- •ASA physical status I-II
- •Thai adult, aged 18-65 years old
- •Normal Body Mass Index (BMI = 18.5-24.9)
排除标准
- •Anticipated difficult airway (e.g., Mallampati classification 3-4, interincisal distance < 35 mm., thyromental length < 60 mm., limited neck mobility)
- •Nasal infection or systemic infection
- •Abnormal coagulation status or having bleeding disorder or taking anticoagulation/antiplatelet medication
- •History of recurrent epistaxis since adulthood
- •Allergic rhinitis that necessitates the use of glucocorticoids, antihistamine, antileukotriene or decongestant in the past 4 weeks
- •History of nasal trauma or abnormality (e.g., trauma in mid-face region, nasal surgery, nasal polyps, chronic sinusitis, abnormal nasal vasculature, tumor in nasal region, radiotherapy in nasal region)
- •Craniofacial deformity syndrome
- •Using nasal oxygen or Continuous Positive Airway Pressure (CPAP)
- •Previous nasotracheal intubation or nasogastric tube placement within 3 months
- •Diagnosed as having a mental disorder
- •Drop-out criteria:
- •Unable to complete intubation procedure
- •Intubation failed on both nostrils
- •When intubation was only possible with a tube smaller than 6.5 internal diameter (ID) in male and 6.0 ID in female
- •Inadequate data collection
研究组 & 干预措施
Control group
conventional nasotracheal intubation procedure
Guided group
use suction catheter guided endotracheal tube through the nasal passage
干预措施: suction catheter (Device)
结局指标
主要结局
Extent of Bleeding
时间窗: measured from video recorded at insert to withdraw videolaryngoscope
The video from video laryngoscope will be recorded at the moment during and immediately after successful intubation, which will be later reviewed by primary outcome assessor that not involved in the procedure. Accounting for only bleeding observed at posterior pharyngeal area, which originate from trauma from attempt to pass ETT through the nasal passage into the pharynx. Assessment of bleeding will be scored at the most severe bleeding state observed from inserting to the removal of video laryngoscope after successful intubation. The extent of bleeding will be graded as: "Grade 0" = no bleeding "Grade 1" = blood-stained tube and/or cuff "Grade 2" = blood-stained posterior pharyngeal wall (traces or streak of blood) "Grade 3" = blood pooling at posterior pharyngeal wall
Incidence of Bleeding
时间窗: measured immediately after successful intubation
rate of incidence of bleeding * No Bleeding (Grade 0) * Bleeding (Grade 1, 2, 3)
次要结局
- Ease of Navigation(measured immediately after successful intubation)
研究者
Duangdee Rummasak
Assoc. Prof.
Mahidol University