Assessment of a Properly Video Stylet Angulation for Nasotracheal Intubation
研究概览
地位
条件
详细说明
In oro-maxillo-facial surgery, it is a common practice for patients receiving general anesthesia with nasotracheal intubation to widen the surgical field and to ease undergoing surgery. However, a nasotracheal tube blindly passing through the nasal cavity may easily result in nasal cavity and oropharynx damages.
The aim of the study is to investigate use which angulation including 45 degree, 70 degree and 90 degree is appropriate to assist the nasotracheal tube passing the nasal cavity, oropharynx, and advanced into the tracheal. Patients are randomized into three groups by 45 degree, 70 degree and 90 degree to facilitate nasotracheal tube sliding through into trachea and compared with each other group.
Hemodynamic changes in each time interval, each time taken of tube going through the nasal cavity, tube advanced from oropharynx into trachea will be recorded. The incidence of using the video stylet with different angulation to accurately place tube tip into trachea, intubation related side effects and complications are recorded at postoperative time stages.
研究类型
注册 (预期的)
联系人和位置
学习联系方式
- 姓名：Pin-Yang Hu, MD.
- 电话号码：7035 88673121101
- 邮箱：u8901090@gmail.com
研究联系人备份
- 姓名：Kuang-I Cheng, MD, PhD
- 电话号码：7035 88673121101
- 邮箱：kuaich@kmu.edu.tw
学习地点
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Sanmin District
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Kaohsiung、Sanmin District、台湾、807
- 招聘中
- Kaohsiung Medical University Chung-Ho Memorial Hospital
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接触：
- Pin-Yang Hu, MD
- 电话号码：7035 88673121101
- 邮箱：u8901090@gmail.com
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- undergoing oro-maxillofacial surgery with general anesthesia(GA)
- ASA(American Society of Anesthesiologists):Ι to III
- 20-65 y/o
- mouth Open > 3cm
- the systemic disease exclusion
- conscious clear and without major Neurocognitive Disorder
- Mandarin or Taiwanese speaker
- agree the purpose of the study and sign the ICF
Exclusion Criteria:
- difficult airway assessment [limited mouth opening<3cm, limited neck motion(thyromental distance < 6cm]
- previous head neck surgery history
- upper abnormal airway diagnosed, easily epistaxis, and both sides nasal cavities obstruction.
- reject to participate
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
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45° group
Uses the video stylet with 45 degree(The tip of the trachway in 45°-55°) to assist the nasotracheal tube passing the nasal cavity, oropharynx and advanced into the trachea
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70° group
Uses the video stylet with 70 degree(The tip of the trachway in 60°-70°)to assist the nasotracheal tube passing the nasal cavity, oropharynx and advanced into the trachea
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90° group
Uses the video stylet with 90 degree(The tip of the trachway in 80°-90°)to assist the nasotracheal tube passing the nasal cavity, oropharynx and advanced into the trachea
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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success rate of video stylet angulation and successful first tube attempt in 60 seconds
大体时间：During procedure
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Time: TTI(time taken advancement) is less than 60 seconds in first tube attempt, it defines successful; TTI(time taken advancement) is over 60 seconds in first tube attempt, it defines unsuccessful.
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During procedure
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success rate of video stylet angulation and successful first tube attempt in Lung's ventilation
大体时间：During procedure
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Lung's ventilation: The lung's ventilation is success.
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During procedure
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time taken advancement(TTI)
大体时间：During procedure
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time taken advancement from nasal cavity into trachea in each time interval
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During procedure
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困难插管评估（IDS）
大体时间：过程中
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插管后需要通过插管困难量表（The Intubation Difficulty Scale，IDS，1997）评估插管困难。
尝试次数>1，得分“N1”；操作员数量>1，得分“N2”；替代技术的数量，得分“N3”； Comark等级-1，得分“N4”；所需提升力正常，得分“N5=0”；所需提升力增加，得分“N5=1”；喉压未应用，评分“N6=0”；施加喉压，评分“N6=1”；声带外展，评分“N7=0”；声带移动性内收，评分“N7=1”。
IDS=分数总和(N1-N7)。
如果IDS得分增加，“0”表示“容易”，“0<IDS≤5”表示“轻微困难”，“5<IDS”表示“中等至较大困难”，“IDS=∞”表示“不可能插管”。
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过程中
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声门级（Cormack Grade）的评估
大体时间：过程中
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插管后需要评估声门等级（Cormack Grade）。
等级定义： 1级：声门全观； 2a 级：声门局部观； 2b 级：仅杓状软骨； 3级：仅会厌； 4 级：声门和会厌均未识别
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过程中
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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插管后引起的口咽出血、声音嘶哑和喉咙痛
大体时间：第2天（手术后的第二天）
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访视问卷用于测量插管后的情况，包括口咽出血、喉咙痛、声音嘶哑、吞咽困难。
口咽出血、咽痛、声音嘶哑、吞咽困难的评分分为无、轻度、中度、重度四级。
所有评估将在术后第二天早上进行评估。
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第2天（手术后的第二天）
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合作者和调查者
调查人员
- 首席研究员：Pin-Yang Hu, MD、Kaohsiung Medical University Chung-Ho Memorial Hospital
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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