The effect of I-gel versus endotracheal tube on atelactasis in paediatric patients undergoing general anesthesia assessed by lung ultrasound: A prospective randomised study.
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Incidence and severity of lung atelactasis assessed by lung ultrasound
研究概览
简要总结
Atelectasis (collapse of part of the lung) is a common complication during and after general anaesthesia in children. It can reduce oxygenation, cause breathing problems, and increase the risk of postoperative complications. Different airway devices used during anaesthesia may influence the risk of atelectasis.
The i-gel is a supraglottic airway device that is easy to insert, causes less irritation, and maintains airway patency during anaesthesia. The endotracheal tube (ETT) is the conventional method for airway management but requires more manipulation, may cause airway irritation, and can be associated with a higher risk of atelectasis.
This study is a randomized clinical trial comparing i-gel and ETT in children aged 1–14 years undergoing elective surgeries lasting more than one hour. One hundred children will be enrolled and randomly assigned to either i-gel or ETT groups. Lung ultrasound, a safe and radiation-free bedside tool, will be used to assess atelectasis at different time points during and after surgery.
The primary outcome is the degree of atelectasis 15 minutes after airway insertion. Secondary outcomes include atelectasis at extubation and 30 minutes after extubation, airway complications (such as sore throat and hoarseness), postoperative pulmonary complications, and hospital stay.
The results of this study will help determine whether i-gel or ETT is better in reducing lung atelectasis and improving recovery in children undergoing anaesthesia.
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
- 1.00 Year(s) 至 14.00 Year(s)（—）
- 性别
- All
入选标准
- •ASA 1-3,elective surgery of duration more than 1 hour in supine position,informed consent from parents/guardians.
排除标准
- •Chest deformities,thoracic surgery history,recent respiratory tract infection,airway abnormality,high aspiration risk.
结局指标
主要结局
Incidence and severity of lung atelactasis assessed by lung ultrasound
时间窗: 15 minutes after airway insertion
次要结局
- Lung atelactasis(at extubation and 30 minutes after extubation)
- Incidence of postoperative airway complication(at 24 hour and 48 hour post-operation)
- Incidence of postoperative pulmonary complications(Within 48 hour)
研究者
Alok jha
IGIMS;sheikhpura,patna