A comparative study of ease of insertion and hemodynamic parameters between Supraglottic airway device - Igel and Classic Laryngeal Mask Airway , in paediatric patients – A prospective randomized study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Compare the ease of insertion , hemodynamic parameters and complications following insertion of I-gel versus Classic Laryngeal mask airway in children
研究概览
简要总结
The use of Supraglottic airway devices in paediatric anaesthesia has increased recently in view of recent advancement in ambulatory surgeries . The most commonly used is the Laryngeal mask airway – Classic which are equipped with an inflatable cuff for sealing the perilaryngeal space . I-gel is a new single use supraglottic airway device without an inflatable cuff. The Aim of the study is to compare the ease of insertion , airway sealing ability and assess hemodynamic parameters and complications in children following insertion of I-gel versus Classic Laryngeal Mask Airway (LMA) in children .
This will be a prospective observational study that will be conducted in the department of Anaesthesia of Christian Medical College and Hospital Ludhiana , in 70 paediatric patients (4 months to 6 years) belonging to American Society of Anaesthesiologists (ASA) I-II .Computer generated random assignation will be done – Group I – I gel and Group II- cLMA will be used.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 4.00 Month(s) 至 7.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Age group 4 months to 6 years , males and females.
- •2.Patients whose guardians provide us with informed consent.
- •4.Scheduled for elective surgical procedures less than one and half hour.
排除标准
- •1.Patients who are not providing consent.
- •2.Patients having difficult airway , restricted mouth opening.
- •3.Patient with risk of aspiration.
- •4.Patients with upper respiratory tract infection.
- •5.Patient with bleeding and clotting abnormality.
- •8.Patients with history of upper gastrointestinal surgery.
结局指标
主要结局
Compare the ease of insertion , hemodynamic parameters and complications following insertion of I-gel versus Classic Laryngeal mask airway in children
时间窗: Immediately after insertion,1 minute, 3 minutes, 5 minutes and 10 minutes after insertion
次要结局
- Compare the hemodynamic parameters and complications following the removal of I-gel and Classic laryngeal mask airway in children(Immediately after removal, 5 minutes and 20 minutes after removal)
研究者
Dr Christina George
Christian Medical College and Hospital, Ludhiana, Punjab