Compare the Effects of Two Different Endotracheal Tubes on The Secretion and Bleeding Volume of Patients During Intubation to Facilitate Nasotracheal Tube Advancement Into Trachea Under Video-laryngoscope
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- success rate
研究概览
简要总结
Either uses two different endotracheal tubes to pass the nasal cavity and to compare the effects on the secretion and bleeding volume of patients during intubation to facilitate nasotracheal tube advancement.
详细描述
- Assess the patient's airway before intubation. EKG, blood pressure and SPO2 are monitored during the process.
- Randomly divided into two groups：Henan Tuoren Endotracheal Tube and Smiths Portex Tracheal tubes.
- Sedation process：Give Fentanyl 1 ug/kg according to the patient's weight via IV.
- Give 1.5ml of Lidocaine without Epinephrine and 0.5ml of Lidocaine with Epinephrine to reduce intranasal bleeding.
- Sedative injection：give Fentanyl 1ug/kg + Thiamylal 5mg/kg + Rocuronium 1mg/kg
- Anesthesia intubation inducer：Propofol 1mg/kg
- Intubation
- Record the bleeding of the oropharyngeal and nasal mucosa、intubation time、Intubation Difficult Scale (IDS score) and number of intubations during intubation.
- Record oropharynx、nostril and oropharynx bleeding in 3 minutes after completion of intubation.
- Evaluate the patient's sore throat, hoarse voice, dysphagia, nasal congestion, nose bleeding, and nasal pain every other day.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
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
- •Age:20-65 years
- •Undergoing oro-maxillofacial surgery
- •Opening mouth > 3 cm
- •Denied any systemic disease.
- •American Society of Anesthesiologists (ASA) class:I-III
排除标准
- •Difficult airway assessed (limited mouth opening, limited neck motion, and thyromental distance < 6cm)
- •Previous head and neck surgery history
- •Upper abnormal airway diagnosed
- •Easily epistaxis
- •Both sides nasal cavities obstruction
研究组 & 干预措施
Henan Tuoren Endotracheal Tube group
Uses the Henan Tuoren endotracheal tube to assist the nasal tracheal tube passing the nasal cavity, oropharynx and advanced into the trachea
干预措施: Henan Tuoren Endotracheal Tube (Device)
Smiths Portex Tracheal tubes group
Uses the Smiths Portex endotracheal tube to assist the nasal tracheal tube passing the nasal cavity, oropharynx and advanced into the trachea
干预措施: Smiths Portex Tracheal Tubes (Device)
结局指标
主要结局
success rate
时间窗: 10 minutes
success rate of tube advancement and successful first tube attempt success rate of tube passing through nasal cavity into trachea
time
时间窗: 10 minutes
time taken in tube advancement time taken in tube advancement from nostril into trachea in each time interval
次要结局
- post-anesthesia care(2 days)