Comparison Of Clinical Performance of Video Laryngoscope Guided Vs Blind Placement of I Gel in Paediatric Patients A Randomised Controlled Open Label Trial
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- To compare clinical performance of video laryngoscope vs blind placement of I-gel in paediatric patients
研究概览
简要总结
Second generation supraglottic airway devices have made airway management safer in children during surgery under general anaesthesia. The i gel is one of the most commonly used devices because it is easy to insert, usually requires fewer attempts, and provides a good seal that allows normal and assisted breathing. Traditionally, doctors insert the i gel without directly seeing the airway, known as blind insertion. However, studies using fibreoptic scopes have shown that even when the breathing looks fine, the device may not always be positioned correctly.
Previous research has compared the blind method with using a video laryngoscope, which is a camera that lets the doctor see the airway while inserting the device. Kumar and colleagues found that using the camera resulted in much fewer malpositions compared to the blind method and also gave better airway seal and visibility, though both methods were similarly successful in overall placement. Another study by Behera and colleagues, which used a different airway device called the Ambu AuraGain, did not find the same benefit, suggesting that results may vary depending on the device type.
Other studies have confirmed that the i gel performs well compared with other airway devices in children, offering faster placement and good ventilation. Imaging studies have also shown that blind insertion can lead to malposition in many children, even when breathing seems adequate. Overall, using video guidance to insert the i gel appears to improve how well the device fits, although more studies are needed in different age groups and situations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 2.00 Year(s) 至 6.00 Year(s)(—)
- 性别
- All
入选标准
- •All paediatric patients 2 to 6 yrs Scheduled for elective infraumbilical surgery in supine position Under general anaesthesia ASA physical status I or II.
排除标准
- •Emergency surgeries non elective procedures Anticipated difficult airway Having history of URTI gastroesophageal reflux Mass in the pharyngeal laryngeal cavity syndromic babies Insertion attempt more than 3.
结局指标
主要结局
To compare clinical performance of video laryngoscope vs blind placement of I-gel in paediatric patients
时间窗: base line time only after insertion will check position of i gel
次要结局
- To compare the hemodynamic parameters & the insertion characteristics such as the number of attempts, ease of insertion & time required for successful insertion between two insertion technique(baseline time only after insertion)
研究者
RAKHI V P
Armed Forces Medical College
