Comparison Among Three Different Video Scope Guided Nasotracheal Intubation: a Prospective, Non-randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 主要终点
- the duration of catheter reaching oropharynx
研究概览
简要总结
Nasotracheal intubation (NTI) has become the most optimal alternative to oral endotracheal intubation for oro-maxillofacial surgery because it can offer an excellent vision field of the mouth. Additional benefits include milder oropharynx stimulation, less airway secretions, and better tolerance for long term endotracheal intubation maintenance. Traditional NTI is performed under the guidance of indirect laryngoscope, which is often accompanied by longer maneuver time and adverse complications such as trauma and bleeding. The development of various visualization tools such as video laryngoscope, video fiberoptic scope and video rigid laryngoscope has greatly improved NTI. However, there is no consensus on which one is the best adjunctive device for NTI. Therefore, a study on a comparison of the clinical efficacy of the above three video scope guided methods for NTI will be conducted.
详细描述
A total of 60 eligible patients will be enrolled in this prospective study, they are scheduled to undergo elective oro-maxillofacial surgeries under general anaesthesia with nasotracheal intubation in the Union Hospital, Tongji Medical College, Huazhong University of Science and Technology. According to the kinds of video methods uesd to assist in nasotracheal intubation, patients will be randomly divided into video laryngoscope group, video fiberoptic scope group and video rigid laryngoscope group, 20 participants in each group. The data of the duration of catheter reaching oropharynx (T1), the duration of catheter reaching glottis (T2), successful intubation time (T3), the first-attempt intubation success rate, the total number of intubations for each participant, whether there is oral and nasal mucosa bleeding, whether the tracheal ring is pressed, whether the catheter is rotated, the heraodynamic changes, and the occurrence of throat complications within 2 hours after surgery, will be recorded respectively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Participants scheduled for elective oro-maxillofacial surgery under general anesthesia.
- •Age between 18 and 65 years old.
- •The American Society of Anesthesiologists (ASA) Ⅰ～Ⅱ.
- •Body mass index (BMI) 18.5～24.9kg/m
- •Mallampati Ⅰ～Ⅱ.
- •Able to give informed consent.
排除标准
- •Participants with severe intranasal diseases.
- •Participants with severe and uncontrolled clotting diseases.
- •Participants with skull base fractures and cerebrospinal fluid leakage.
- •Participants with unstable cardiovascular and cerebrovascular diseases, or with poor tolerance to vagal stimulation.
- •Participants who are deemed ineligible for participation in the clinical trial by the investigator.
- •Participants who have to receive the alternative therapy to establish ventilation after the several attempts for nasotracheal intubation.
结局指标
主要结局
the duration of catheter reaching oropharynx
时间窗: within 1 minute
time requirements for delivering the anterior segment of the endotracheal tube from the nasal cavity to the oropharynx
successful intubation time
时间窗: within 3 minute
time requirements for delivering the anterior segment of the endotracheal tube from the nasal cavity to the trachea
average number of intubations
时间窗: anticipated eight months
average number of nasotracheal intubations for each participant
the first-attempt intubation success rate
时间窗: anticipated eight months
number of successful first-attempt intubation/total number of intubations
the duration of catheter reaching glottis
时间窗: within 1 minute
time requirements for the anterior segment of the endotracheal tube from being put into the nasal cavity to the glottis being exposed
次要结局
- the number of participants whose oral and nasal mucosa bleeds during intubation(within 3 minute)
- Blood pressure values before and after intubation intubation(20 minute)
- the occurrence of throat complications(within 2 hours after surgery)
- the number of participants whose tracheal ring is pressed and catheter is rotated when intubation(within 3 minute)
- Heart rate values before and after intubation intubation(20 minute)
研究者
Zhilin Wu
Principal Investigator
Wuhan Union Hospital, China