Tracheal Tube Cuff Inflation-Deflation Method for Video Assisted Laryngoscope Nasal Intubation in Adults
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- The time period for the second phase of nasal intubation
研究概览
简要总结
The goal of this clinical trial is to compare cuff inflation deflation method versus conventional method using Magill forceps in adult patients scheduled for elective surgery dental or maxillofacial that need nasal intubation. The study question:
Is cuff inflation deflation method for nasal intubation takes a short time than the conventional method using Magill forceps in adult patients scheduled for elective surgery dental or maxillofacial?
We will compare the inflation deflation technique with the Magill forceps technique for nasal intubation in adult patients to see if the inflation deflation technique will take less time and associated with less side effects like cuff perforation and mucosal injury.
Participants will [describe the main tasks participants will be asked to do, interventions they'll be given and use bullets if it is more than 2 items].
详细描述
Magill forceps is used to maneuver the endotracheal tube (ETT) in the posterior oropharynx and place its tip into the laryngeal inlet. While the Magill forceps are useful in guiding the nasotracheal tube past the vocal cords, care must be taken to avoid excessive maneuvering in order to minimize the risk of local trauma and rupture of the nasotracheal tube balloon.
Cuff inflation-deflation method can reduce the apnea time in the adult patients. This, in turn, could point to a reduction in the complications (as desaturation and cardiac arrhythmia) that associated with the prolonged-time procedure.
Written informed consent will be obtained from all patients participating in the trial. The trial will be registered prior to patient enrollment. Ninety patients between the ages of 18 and 60 years with American Society of Anesthesiologists (ASA) physical status I -II , scheduled for elective surgery (dental and maxillofacial) will be enrolled in a prospective randomized observer blinded clinical trial. Patients, who have coagulopathies, have upper airway abnormalities, at risk for aspiration or patient's refusal will be excluded from the study.
Materials and methods
Airway management is subdivided into phases:
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 (Investigator)
盲法说明
The nasal intubation will be performed behind an opaque screen so that observer could not see which approach will be used.
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists (ASA) physical status I-III
- •Scheduled for elective surgery (dental and maxillofacial) in need for nasal intubation.
排除标准
- •Patients, who have coagulopathies,
- •Have upper airway abnormalities,
- •At risk for aspiration or by reasons of
- •Parent's refusal will be excluded from the study
结局指标
主要结局
The time period for the second phase of nasal intubation
时间窗: Intraoperaotive
The time in seconds for the second phase nasal intubation(from the tip of endotracheal tube will be placed in pharynx till it pass the vocal cords
次要结局
- to test whether the inflation-deflation method would decrease the need for Magill forceps in video laryngoscopy assisted nasal intubation in pediatric patients compared with the conventional non-cuff inflation approach.(Intraoperaotive)
- The number of attempts required for successful nasal intubation.(Intraoperaotive)
- Amount of injected air for cuff inflation(Intraoperaotive)
- Assessment of side effects of using Magill forceps during nasal intubation(Intraoperaotive)
- Evaluation of oxygenation state during nasal intubation(preoperative and intraoperative)
- evaluate the anesthetists' experience of using the inflation-deflation method for nasal intubation.(20 minutes after patient recovery)
- Need for external compression and need for help(Intraoperaotive)
- need of endotracheal tube rotation(Intraoperaotive)
研究者
Aiman Al-Touny
Lecturer of Anesthesia and Intensive Care
Suez Canal University