CTRI/2018/04/013297招募中Unknown
Comparative evaluation of insertion characteristics of LMA ProSeal using different techniques in the paediatric age group
Vardhaman Mahavir Medical College and Safdarjung Hospital1 个研究点 分布在 1 个国家目标入组 135 人开始时间: 2018年1月4日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 135
- 试验地点
- 1
- 主要终点
- Haemodynamic parameters
研究概览
简要总结
1-To compare the ease of insertion of LMA ProSeal by three techniques i.e. introducer technique, 90 degree rotation technique and pharyngoscopic technique.
2- Haemodynamic parameters will be recorded before and after insertion of LMA ProSeal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 3.00 Year(s) 至 10.00 Year(s)（—）
- 性别
- All
入选标准
- •Age group of 3 to 10 years of either gender under ASA grade I or II, scheduled for surgery of less than 2 hours duration under general anaesthesia with controlled ventilation using the LMA ProSeal.
排除标准
- •Anticipated difficult airway -Weight <5kg or >kg -Recent upper respiratory tract infection, sore throat, history of asthma.
- •History of systemic or metabolic disorders.
- •Risk of regurgition or aspiration.
结局指标
主要结局
Haemodynamic parameters
时间窗: 1 minute before the insertion of device, at the time of insertion and after the time of insertion.
Assessment of insertion conditions i.e. insertion time, ease of insertion, number of attempts taken, manipulations done, oropharyngeal seal pressure, ease of orogastric tube placement.
时间窗: 1 minute before the insertion of device, at the time of insertion and after the time of insertion.
次要结局
- Postoperative adverse events i.e. Sore throat or Hoarseness(After surgery and First postoperative morning)
研究者
研究点 (1)
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