For Nasotracheal Intubation With Video Rigid Stylet, Which Nostril is Better? A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Total time for intubation
研究概览
简要总结
To determine which nostril is more suitable for nasotracheal intubation with video rigid stylet.
详细描述
Head and neck surgeries usually require nasal intubation, which allows leeway for operative maneuvering in the mouth, pharynx, larynx, and neck. Previous studies have found that the right nostril is more appropriate for nasal intubation using direct laryngoscope or videolaryngoscope. It has been shown that the optical rigid stylet was also an appropriate tool for nasal intubation. However, nasal intubation with rigid optical stylet is technically different from that with laryngoscope. It is unknown whether the choice of nostril could affect the intubation using rigid optical stylet. The main aim is to determine which nostril is more suitable for nasal intubation with video rigid stylet.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years;
- •American Society of Anesthesiologists physical status I~II;
- •Scheduled to undergo elective oral and maxillofacial surgery requires nasal intubation;
- •The expected operation time < 3 hours;
- •Extubation in operation room and do not scheduled to preventive tracheotomy;
- •Patients who were able to breathe clearly and equally through both nostrils.
排除标准
- •Patients had history of difficult intubation or presented with an anticipated difficult airway;
- •Patients requiring nasogastric tube insertion;
- •Presence of contraindications of nasal intubation;
- •Due to surgical requirement, intubation must be completed through one nostril;
- •Presence of severe nasal obstruction,deformities of the nasal cavity, or other serious nasal diseases;
- •History of severe epistaxis or epistaxis within a month;
- •Previous history of nasal and/or laryngeal surgery;
- •Previous experience with nasal intubation;
- •History of schizophrenia, Parkinson's disease or profound dementia, or language barrier;
- •Participate in other clinical studies;
- •Refusal to sign informed consent.
结局指标
主要结局
Total time for intubation
时间窗: Procedure (From when the device tip entered the nostril to when the tube entered the trachea.)
The duration from when the device tip entered the nostril to when the tube entered the trachea, as confirmed by capnography.
次要结局
- Total success rate(Procedure (Up to the tube entered the trachea.))
- First-attempt success(First-attempt of nasal intubation with video rigid stylet.)
- Times of intubation-attempts(Procedure (From when the device tip entered the nostril to when the tube entered the trachea.))
- The time for device insertion(Procedure (From when the device tip entered the nostril to when it passed through the vocal cord.))
- The time for tube insertion(Procedure (From when the tip of the device passed through the vocal cord to when the tube was confirmed inserted into the trachea.))
- Incidence and severity of epistaxis(Procedure (Up to completion of intubation))
研究者
Yang Xudong
Project leader
Peking University