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临床试验/CTRI/2025/09/095035
CTRI/2025/09/095035尚未招募不适用

Comparison of oropharyngeal leak pressure of Blockbuster® Laryngeal Mask Airway with Laryngeal Mask Airway Proseal™ in children: A randomized comparative study.

MS Ramaiah Medical College Bangalore MSRIT Post New BEL Road Bangalore 5600541 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2025年10月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
92
试验地点
1
主要终点
Comparison of oropharyngeal leak pressure of Blockbuster® Laryngeal Mask Airway with Laryngeal Mask Airway Proseal™ in children under controlled ventilation

研究概览

简要总结

Supraglottic airway devices (SADs) have now become the commonly used modality of airway management not only in adults but in children undergoing elective surgical procedures under general anaesthesia. They not only provide adequate ventilation and oxygenation but are also associated with lower respiratory related adverse events, thus replacing the need for tracheal intubation in children.

**a.**The popularity of the SADs has led to various modification in the design as well as in the material used since its first introduction into clinical anaesthesia by Archie Brain. Blockbuster® LMA is a recent addition to the armamentarium of SADs. It is made of medical grade silicone with an anatomically shaped airway tube. The cuff of the device is made of silicone which is more elastic and malleable, thus thought to provide a high sealing pressure.

The LMA Proseal™ with its unique design features is regarded as the state-of-the-art SAD and is compared with all latest SADs. The LMA Proseal™ is the commonly used SAD in children in our institution.  There is paucity of literature comparing BlockBuster® LMA with LMA Proseal™ in children.

The hypothesis of this study is that the BlockBuster® LMA will provide a higher oropharyngeal leak pressure than LMA Proseal™ in children undergoing elective short-duration surgeries under general anaesthesia.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
2.00 Year(s) 至 10.00 Year(s)(—)
性别
All

入选标准

  • American Society of Anaesthesiologists (ASA) physical status 1 and 2.

排除标准

  • Laparoscopic surgeries History of obstructive sleep apnoea Intraoral surgeries Increased risk of aspiration Anticipated difficult airway Surgery in positions other than supine Upper airway pathology Abnormal upper airway anatomy.

结局指标

主要结局

Comparison of oropharyngeal leak pressure of Blockbuster® Laryngeal Mask Airway with Laryngeal Mask Airway Proseal™ in children under controlled ventilation

时间窗: 5 minutes after the insertion of the device

次要结局

  • Compare Blockbuster® Laryngeal Mask Airway with Laryngeal Mask Airway Proseal™ with respect to(Ease of insertion)

研究者

发起方
MS Ramaiah Medical College Bangalore MSRIT Post New BEL Road Bangalore 560054
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Zeeba Taranum

MS Ramaiah Medical College

研究点 (1)

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