Comparison of First Attempt Success in Nasotracheal Intubation Using Macintosh Videolaryngoscope vs. Flexible Bronchoscope: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- First-attempt success rate of nasotracheal intubation
研究概览
简要总结
Participants are randomly assigned to two groups: one group undergoes nasotracheal intubation using a videolaryngoscope, while the other group undergoes nasotracheal intubation using a flexible bronchoscope. The primary outcome is the first-attempt success rate, assessed at the time of tracheal tube placement. Additional outcomes include the degree of subglottic injury upon extubation, and the incidence and severity of sore throat and hoarseness at 1 hour and 24 hours postoperatively, as well as overall intubation success rates.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 19 years or older
- •Undergoing ear, nose, and throat (ENT) surgery requiring nasotracheal intubation
排除标准
- •Refusal to participate in the study
- •History of gastroesophageal reflux disease
- •History of surgery or radiation therapy involving the upper airway
- •Presence of severely loose teeth
研究组 & 干预措施
Videolaryngoscope Group
干预措施: Macintosh videolaryngoscope (Device)
Flexible Bronchoscope Group
干预措施: Flexible bronchoscope (Device)
结局指标
主要结局
First-attempt success rate of nasotracheal intubation
时间窗: At the time of tracheal intubation
The proportion of patients in whom nasotracheal intubation is successfully completed on the first attempt, comparing the videolaryngoscope group with the flexible bronchoscope group.
次要结局
- Postoperative sore throat severity(1 hour and 24 hours postoperatively)
- Incidence of postoperative hoarseness(1 hour and 24 hours postoperatively)
- Cormack-Lehane grade(At the time of tracheal intubation)
- Changes in blood pressure(Within 5 minutes before and after intubation)
- Changes in heart rate(Within 5 minutes before and after intubation)
- Changes in saturation(Within 5 minutes before and after intubation)
- Changes in bispectral value(Within 5 minutes before and after intubation)
- Degree of subglottic injury(At the time of extubation)
- POGO score(At the time of tracheal intubation)