The Use of Supraglottic I-Gel Airway as a Conduit for Fiberoptic Guided and Blind Intubation in Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 2
- 主要终点
- The success rate of first attempt intubation
研究概览
简要总结
Aim of the work
To compare between use of I-gel as a conduit for blind intubation and as a conduit for fiberoptic guided intubation in children and also aim to validate the use of I-gel as conduit for blind intubation in absence of fiberoptic or lack of experience of its use.
Objectives:
- To validate I-gel use as blind intubating conduit in children.
- To Estimate the duration of blind intubation using I-gel and duration of fiberoptic guided intubation through I-gel.
Ethical Considerations
The study protocol will be approved by the Research Ethics Committee.
详细描述
Introduction:
A supraglottic airway device is designed to maintain a clear airway while sitting above, and creating a seal around the larynx. It may be used in elective surgery, as an airway rescue device in failed tracheal intubation, as a conduit for tracheal intubation, or in emergencies such as cardiorespiratory arrest, both in and out of hospital.
'First-generation'supraglottic airway devices are simple airway tubes such as the laryngeal mask airway (LMA) Classic. 'Second generation' devices contain suction ports and integral bite blocks, these include the LMA Proseal and the i-gel.
The I-gel is the innovate second generation supraglottic airway and it is considered the first major development since LMA. The I-gel has changed the face of airway management and is now widely used in anesthesia and resuscitation across the globe. It is made from a medical grade thermoplastic elastomer and it is designed to create a non-inflatable, anatomical seal of the pharyngeal, laryngeal and perilaryngeal structures.
Pediatrics are not small adults, there are a number of anatomical differences which make airway management difficult than adults. Predicatably, these differences are most pronounced at birth and the most unfamiliar(non-adult like) airway is encountered in neonates and infants under 1 year of age.
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
- 2 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA physical status I-II
排除标准
- •Known difficulty of intubation. (Airway assessment clinically for presence of retrognathia, small mandibular cavity, limited neck or mandibular mobility and presence of syndromes associated with facial abnormalities e.g Pierre Robin sequence, Treacher Collins, Hurler's Hunter's syndrome (mucopolysaccharidoses), Beckwith-Wiedemann syndrome and Down's syndrome.)
- •Emergency surgery.
- •Risk of aspiration (e.g; full stomach, GERD, CHPS).
- •Respiratory tract infections.
- •Children not fitted with I-Gel.
研究组 & 干预措施
Group B(blibd)
group B (blind); an appropriate size endotracheal tube will be introduced through I-gel blindly. Only smooth intubation without force together with manoeuvres necessary to correct the position of tracheal tube will be allowed. Only one attempt of blind intubation is allowed to avoid airway injury. Any resistance to first attempt tube insertion will indicate failure of blind tube insertion.
干预措施: I-gel (Device)
Group C(control)
group C (control), a paediatric fibrescope will be primed with an appropriate size tracheal tube. The fibrescope will be introduced through I-gel and guide tracheal intubation. After insertion of tube and confirmation of position, the fiberscope will be removed
干预措施: I-gel (Device)
结局指标
主要结局
The success rate of first attempt intubation
时间窗: The success rate for insertion will be recorded 5 minutes after induction of anesthesia
assessing the success rate of first attempt to insert the endotracheal tube through I-gel either blindly or by a fiberscope
次要结局
未报告次要终点
研究者
Amr Galal EL-Sherbeny
Assistant lecturer of anesthesia
Cairo University