Comparison of the Supreme™ And Proseal™ Laryngeal Mask Airways in Infants: A Prospective Randomised Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 主要终点
- performance characteristics
研究概览
简要总结
In this study, the Supreme and ProSeal LMAs in infants were compared by measuring their performance characteristics, including insertion features, ventilation parameters, induced changes in hemodynamics and rates of postoperative complications.
详细描述
Both the Supreme™ and ProSeal™ laryngeal mask airways (LMAs) are widely used for paediatric anaesthesia; however, LMA use in infants is limited, as many anaesthesiologists prefer to use tracheal intubation in infants.
In this study, the Supreme and ProSeal LMAs in infants were compared by measuring their performance characteristics, including insertion features, ventilation parameters, induced changes in hemodynamics and rates of postoperative complications.
Infants of ASA physical status I who were scheduled for elective, minor, lower abdominal surgery were divided into two groups: the Supreme LMA group and the ProSeal LMA group. Heart rate (HR), oxygen saturation and end tidal carbon dioxide values were recorded both before and after LMA insertion, as well as both before and after extubation. After extubation, complications and adverse effects were noted.
Demographics and surgical data were similar between the two groups. LMA insertion times for the ProSeal group were shorter, the leakage pressure for the ProSeal group was statistically higher. The ProSeal LMA is superior to the Supreme LMA for use in infants, due to its ease of insertion, high oropharyngeal leakage pressure and fewer induced changes in hemodynamics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •scheduled for elective, minor (<1 hour duration), lower abdominal surgery, including unilateral herniorrhaphy and unilateral orchidopexy
排除标准
- •premature birth, potentially difficult airway, clinically significant upper respiratory tract infection and risk of aspiration, such as gastro-oesophageal reflux disease
研究组 & 干预措施
ProSeal group
This group received the ProSeal LMA for supraglottic airway intubation and ventilation during anaesthesia.
干预措施: supraglottic airway intubation (Device)
Supreme group
This group received the Supreme LMA for supraglottic airway intubation and ventilation during anaesthesia.
干预措施: supraglottic airway intubation (Device)
结局指标
主要结局
performance characteristics
时间窗: operation duration
insertion time in minutes
次要结局
- haemodynamics(operation duration)
研究者
Canan Tulay ISIL
Specialist, M.D.
Sisli Hamidiye Etfal Training and Research Hospital