A Comparative Study Between Atomization and Nebulization for Airway Topicalization During Awake Nasotracheal Fiberoptic Intubation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Bronchoscopy-guided intubation time
研究概览
简要总结
Intubation of difficult airway is a challenge for anesthetist. There many causes of difficult airway, and previous studies concluded that awake fiber-optic intubation (AFOI) is the gold standard for the management of these patients. Several studies showed that airway nerve blocks provide rapid and deep airway anesthesia, however, due to their several disadvantages, topicalization of the airway represents a promising alternative to them. Some studies revealed that nebulization and atomization of the airway provide adequate anesthesia for AFOI. In the present study, we try to find out which is more effective for topicalization of the airway during nasotracheal AFOI; nebulization or atomization. We used a simple atomization device as a modification of the McKenzie technique.
详细描述
Site of the Study: Zagazig university surgical hospitals.
Type of the Study: Prospective randomized double-blinded clinical trial.
Withdrawal Criteria:
The patient has the right to withdraw from the study at any time without any negative consequences on medical or surgical treatment plan.
Randomization:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Outcomes Assessor)
盲法说明
Both the anesthesiologist performing the fibroscopy and the data collector will be blind to group assignment.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consent obtained from all patients included in this study.
- •Age 18 - 60 years, of both sexes.
- •ASA class I, II and III.
- •Anticipated difficult airway; SARI score ≥ 4, airway pathology, craniofacial abnormalities, or cervical spine instability.
- •Scheduled for elective non-cardiac surgery requiring general anesthesia and endotracheal intubation.
排除标准
- •Patient refusal, uncooperative and mentally retarded patients.
- •Full stomach patients.
- •Patients with nasal fractures or trauma, fracture base of the skull, bleeding disorder, epistaxis or active oral bleeding.
- •Active cough or respiratory tract infection and bronchial asthma.
- •Allergy to lidocaine.
- •Raised intracranial pressure or intraocular pressure.
- •Cerebral aneurysm, history of recent acute myocardial infarction or cerebrovascular accident.
研究组 & 干预措施
Nebulization with lidocaine
A face mask nebulizer with oxygen flow rate of 8 L/min will be used to deliver 10 mL of 2% lidocaine. Patients will be encouraged to inhale deeply to facilitate entrainment of nebulized LA into their airway. Adequate topical anesthesia will be confirmed by heaviness or numbness of the tongue.
干预措施: Nebulization with lidocaine (Procedure)
Atomization with lidocaine
Our simple atomization device, a modification of the McKenzie technique, will be used. One end of oxygen bubble tubing will be cut to fit into the barrel of 1 mL syringe and attached to one connector of a 3-way tap. A 10-mL syringe filled with 2% lidocaine will be attached to the other connector of the 3-way tap. A 6 Fr suction catheter, with its colored end cut and its distal blind end cut open, will be attached to oxygen bubble tubing via the male Luer connector of the 3-way tap. The other end of bubble tubing will be then attached to an oxygen source turned on to deliver a flow of 6 L/min. As LA is slowly atomized as a jet-like spray, the catheter will be directed towards the soft palate and posterior pharynx in a controlled fashion during patients' inspiration to topicalize the airway. Patients will be asked to take full vital capacity breaths of atomized LA contained oxygen. Adequate topical anesthesia will be confirmed by tongue heaviness or numbness
干预措施: Atomization with lidocaine (Procedure)
结局指标
主要结局
Bronchoscopy-guided intubation time
时间窗: Intraoperative (during intubation)
Time from passing the flexible fiberoptic bronchoscope tip through the nostril to the first reading obtained by the capnograph after endotracheal intubation
次要结局
- Vocal Cord Position Score:(Intraoperative (during intubation))
- Intubating Condition Score:(Intraoperative (during intubation))
- Intraoperative Patient Comfort Score:(Intraoperative (during and immediately post-intubation))
- Postoperative Patient Satisfaction Score:(Postoperative 24 hours)
研究者
Ashraf Torki
Lecturer of Anesthesia, Zagazig University (Principal Investigator)
Zagazig University