跳至主要内容
临床试验/CTRI/2024/03/064792
CTRI/2024/03/064792已完成2/3 期

Comparison of Oropharyngeal Leak Pressure between Laryngeal Mask Airway Supreme and Blockbuster Laryngeal Mask Airway in Different Head and Neck Positions: A Prospective, Comparative, Randomized Study

Riddhi Rajan1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年4月6日最近更新:

试验速览

阶段
2/3 期
状态
已完成
发起方
入组人数
90
试验地点
1
主要终点
Oropharyngeal leak Pressure with head in the neutral, flexed, extended and rotated to left position

研究概览

简要总结

The  second generation supraglottic  airways  have become the standard of care for positive pressure ventilation .  The leak pressures determine their efficacy for ventilation and safety.  The evaluation of leak pressures in different head and neck position  will increase their clinical utility and avoid Endotracheal Tube placement  for all surgeries involving changes in head  and neck position. The patient shall benefit from smooth emergence, decreased requirement of narcotics and anesthetic agents  and avoids airway instrumentation.

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
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Elective surgeries of duration less than 3 hours
  • Any elective surgery requiring Laryngeal Mask Airway use.

排除标准

  • BMI more than 35KG/M2 Pathology of neck such as cervical spondylosis Anticipated difficult airway Risk of aspiration.

结局指标

主要结局

Oropharyngeal leak Pressure with head in the neutral, flexed, extended and rotated to left position

时间窗: Immediately after insertion intraoperatively, within 30 mins of insertion of LMA

次要结局

  • Peak airway pressure(Immediately after insertion intraoperatively, within 30 mins of insertion of LMA)
  • Expired tidal volume(Immediately after insertion intraoperatively, within 30 mins of insertion of LMA)
  • End tidal CO2(Immediately after insertion intraoperatively, within 30 mins of insertion of LMA)
  • Difference between inspired & expired volume(Immediately after insertion intraoperatively, within 30 mins of insertion of LMA)
  • Difference between leak pressure & airway pressure(Immediately after insertion intraoperatively, within 30 mins of insertion of LMA)
  • Time to insert SAD(From taking Laryngeal mask Airway in hand to Obtaining square shaped capnogram on the monitor,within 5 mins)
  • successful placement in the first attempt(During insertion, within first 5 mins)
  • failed placement of SAD(During Insertion, within first 10 mins)

研究者

发起方
Riddhi Rajan
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Riddhi Rajan

Sri Ramachandra Institute of Higher Education and research

研究点 (1)

Loading locations...

相似试验

Comparison of Efficacy between Laryngeal Mask Airway... | 临床试验