Tracheal Tube Cuff Inflation-deflation Method for Video Laryngoscope-assisted Nasal Intubation in Pediatric Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- to test whether the inflation-deflation method (pre-cuff inflation) would decrease the need for Magill forceps in video laryngoscopy assisted nasal intubation in pediatric patients compared with the conventional non-cuff inflation approach. T
研究概览
简要总结
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 pediatric patients, a population with known physiological limitations in respiratory reserve. This, in turn, could point to a reduction in the complications (as desaturation and cardiac arrhythmia) that associated with the prolonged-time procedure.
详细描述
the investigator will compare the cuff inflation-deflation method versus the conventional method of nasal intubation in pediatric patients for the need of using Magill forceps 90 pediatric patients between the ages of 3 and 12 years with the American Society of Anesthesiologists (ASA) physical status I-II, scheduled for elective surgery (dental and maxillofacial) will be enrolled in a prospectively randomized observer-blinded clinical trial. 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.
Airway management is subdivided into phases:
- Phase 1: Passage of the endotracheal tube through the nose into the pharynx
- Phase 2: Video-laryngoscope-guided passage of the endotracheal tube through the pharynx into the trachea.
Phase 2 can be performed with the tracheal tube cuff inflation-deflation method vs. non-cuff inflation method. A Magill forceps can be used to guide the endotracheal tube pass through the pharynx and glottis into the trachea if required.
Tracheal tube cuff inflation-deflation method: Tracheal tube cuff is inflated with a variable amount of air (volume of air is depending on the level of the larynx). Once the tip of endotracheal tube at the laryngeal inlet, the cuff of the endotracheal tube is deflated and advanced into the trachea
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists (ASA) physical status I-II,
- •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
研究组 & 干预措施
Conventional nasal intubation
Passage of an endotracheal tube via the nare followed by video laryngoscopy-assisted passage through the glottis, with or without the aid of Magill forceps
干预措施: cuff deflation-inflation -deflation method (Procedure)
Nasotracheal Intubation with cuff inflation-deflation method
Nasotracheal intubation placed with video laryngoscopy assistance, via the tracheal tube cuff inflation-deflation method with or without the aid of Magill forceps
干预措施: cuff deflation-inflation -deflation method (Procedure)
结局指标
主要结局
to test whether the inflation-deflation method (pre-cuff inflation) would decrease the need for Magill forceps in video laryngoscopy assisted nasal intubation in pediatric patients compared with the conventional non-cuff inflation approach. T
时间窗: during nasal intubation : 60 seconds
The percentage of patients who did not require Magill forceps for nasal intubation success was recorded.
次要结局
- The time period for the second phase nasal intubation(60 seconds)
- The number of attempts required for successful nasal intubation.(120 seconds)
- Amount of injected air for cuff inflation(15 seconds)
- Assessment of side effects of using Magill forceps during nasal intubation(Intraoperative and in the first 48 postoperative hours])
- evaluate the anesthetists' experience of using the inflation-deflation method for nasal intubation.(20 minutes after complete recovery of patients)
- Evaluation of oxygenation state during nasal intubation(preoperative and intraoperative)
研究者
Tarek F.Tammam
Tarek F.Tammam,M.D,Ph.D,Department of Anesthesia and intendive care,Faculty of Medicine.
Suez Canal University