Assessment of a Properly Video Stylet Angulation for Orotracheal Intubation
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- success rate of video stylet angulation and successful first tube attempt in 60 seconds
研究概览
简要总结
Uses the video stylet with different angulation to assist the orotracheal tube passing the oral cavity, oropharynx and advanced into the trachea
详细描述
In the patients receiving general anesthesia with nasotracheal or orotracheal intubation is common. However, a orotracheal tube blindly passing through the oral cavity and oropharynx may easily result in oral cavity and oropharynx damages.
The advancement of the tube from oropharynx into trachea may assist using the video stylet.
The aim of the study is to investigate use which angulation including 45 degree, 70 degree and 90 degree is appropriate to assist the orotracheal tube passing the oral cavity, oropharynx, and advanced into the trachea.
Patients are randomized into three groups by 45 degree, 70 degree and 90 degree to facilitate orotracheal 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 oral 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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •undergoing surgery with general anesthesia(GA)
- •ASA(American Society of Anesthesiologists):Ι to III
- •20 to 65 years old
- •mouth Open > 3 cm
- •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
排除标准
- •difficult airway assessment [limited mouth opening < 3cm, limited neck motion(thyromental distance < 6cm)]
- •previous head neck surgery history, oral and respiratory tract tumors, oral infections, neck disease, loosen tooth
- •morbid obesity
- •reject to participate
结局指标
主要结局
success rate of video stylet angulation and successful first tube attempt in 60 seconds
时间窗: During procedure
successful rate of the properly video stylet angulation passing through oral cavity into trachea. 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.
time taken advancement(TTI)
时间窗: During procedure
time taken advancement from oral cavity into trachea in each time interval
assessment of difficult intubation(IDS)
时间窗: During procedure
Assessment of difficult intubation by Intubation Difficulty Scale(The Intubation Difficulty Scale, IDS, 1997) is required after intubation. Number of Attempts\>1, score "N1"; Number of Operators \>1, score "N2"; Number of Alternative Techniques, score "N3"; Comark Grade -1, score "N4"; Lifting Force Required Normal, score "N5=0"; Lifting Force Required Increased, score "N5=1"; Laryngeal Pressure Not applied, score "N6=0"; Laryngeal Pressure Applied, score "N6=1"; Vocal Cord Mobility Abducion, score "N7=0"; Vocal Cord Mobility Adducion, score "N7=1". IDS=Sum of scores(N1-N7). If IDS score gains "0" means "Easy", "0\<IDS≤5" means "Slight Difficulty", "5\<IDS" means "Moderate to Major Difficulty", "IDS=∞" means "Impossible intubation".
assessment of Glottic grade(Cormack Grade)
时间窗: During procedure
Assessment of Glottic grade(Cormack Grade) is required after intubation. The definitions of grade: Grade 1: full view of the glottis; Grade 2a: partial view of the glottis; Grade 2b: arytenoids only; Grade 3: epiglottis only; Grade 4: neither glottis or epiglottis identified
success rate of video stylet angulation and successful first tube attempt in Lung's ventilation
时间窗: During procedure
successful rate of the properly video stylet angulation passing through oral cavity into trachea. Lung's ventilation: The lung's ventilation is success.
次要结局
- post-intubation induced oropharyngeal bleeding, hoarseness and sore throat(Day 2(the day after the operation))
研究者
Chia-Heng Lin, MD
Physician
Kaohsiung Medical University Chung-Ho Memorial Hospital