Application of Electrically Driven Atomized Surface Anesthesia to Awake Endotracheal Intubation in Patients With Predictably Difficult Airway.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 230
- 试验地点
- 1
- 主要终点
- cough score
研究概览
简要总结
This is a parallel and randomized-controlled clinical study aimed to identify the optimized size of atomized particles of 2% lidocaine that can provide the best topical anesthesia during ATI. To determine the effect of nebulization with different sizes of atomized particles of 2% lidocaine on cough, reaction, and comfort during ATI in patients with predicted difficult airway.
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
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with distinctly difficult airways：(1) Patients with medical history indicating difficult airways.(2) Patients suffering from severe burn scars.(3) Patients suffering from severe obstructive sleep apnea syndrome.(4)Patients suffering from severe congenital dysplasia.
- •Patients with suspected difficult airway:
- •Patients with risk factors underwent a medical history for evaluation:(1)Patients with ankylosing spondylitis.(2) Patients with rheumatoid arthritis.(3)Patients with degenerative osteoarthritis.(4)Patients with epiglottitis. (5)Patients with acromegaly.(6)Patients with morbid obesity.(7)Patients with subglottic stenosis. (8) Patients with enlarged thyroid or tonsils.(9)Patients with mediastinal mass.(10)Patients with throat tumors.
- •Patients with risk factors underwent a physical examination for evaluation:(1)Patients with BMI > 26 kg/m
- •(2)Patients with Mallampati class 3 or
- •(3)Patients with thyromental distance<60 mm (corresponding to an average distance of 3 finger breadths).(4)Patients with limited mouth opening with interincisor distance<30 mm.(5)edentulous patients.(6)When the patient closed his mouth in a natural state, the upper incisor was situated in front of the lower incisor.(7)When the mandible is extended forward, the lower incisors of the patient can not protrude beyond the upper incisors.(8)The patient's jaw exhibits stiffness, with minimal elasticity or presence of a tumor.(9)The patients have a short neck with a thick circumference.(10)The patients are unable to touch their chest wall with their jaw, or extend their neck.(11)The patients's palate shape is either characterized by a high arch or is extremely narrow.
排除标准
- •(1) refusal to participate in the study; (2) airway bleeding; and (3) known allergies to local anesthetics.
研究组 & 干预措施
Group A
Participants in the A group received 2% lidocaine by A model atomizer.
干预措施: atomizer (Other)
Group B
Participants in the B group received 2% lidocaine by B model atomizer.
干预措施: atomizer (Other)
Group C
Participants in the C group received 2% lidocaine by C model atomizer.
干预措施: atomizer (Other)
Group D
Participants in the D group received 2% lidocaine by D model atomizer.
干预措施: atomizer (Other)
结局指标
主要结局
cough score
时间窗: during intubation
Investigators will record cough score during intubation.
次要结局
- reaction and discomfort scores(during intubation.)
- intraoperative hemodynamic parameters(endotracheal tube insertion, inflation of the tracheal tube cuff and 1 minute after endotracheal tube insertion)