跳至主要内容
临床试验/CTRI/2025/09/094491
CTRI/2025/09/094491尚未招募1/2 期

Comparative evaluation of the Air Q and Baska Mask in patients undergoing ambulatory surgery under general anesthesia.

Dr Moopens Medical College1 个研究点 分布在 1 个国家目标入组 118 人开始时间: 2025年10月15日最近更新:

试验速览

阶段
1/2 期
状态
尚未招募
发起方
入组人数
118
试验地点
1
主要终点
The Baska Mask’s non-inflatable cuff may offer superior sealing, while the Air-Q with blocker provides easier insertion and dynamic pressure regulation, potentially reducing airway morbidity.

研究概览

简要总结

This double-blinded, randomized controlled trial aims to compare the efficacy and safety of two supraglottic airway devices—the Baska Mask and the Air-Q—in adult patients undergoing elective minor or ambulatory surgeries under general anesthesia. A total of 118 patients, aged 18–60 years, classified as ASA physical status I or II with a BMI <40 kg/m², will be recruited and randomly assigned to either device group.

Both devices will be inserted by experienced anesthesiologists without the use of neuromuscular blockers, and the primary parameters assessed will include insertion time, ease of insertion, oropharyngeal leak pressure (OLP), ventilation adequacy, and number of insertion attempts. Hemodynamic stability and airway-related complications, including sore throat, mucosal trauma, and postoperative nausea and vomiting, will also be monitored.

The Air-Q, with its self-pressurizing cuff and gastric protection features, is evaluated as a newer alternative to the Baska Mask, which is known for its self-sealing cuff and integrated suction system. The study’s outcomes aim to provide evidence-based guidance on optimal supraglottic airway device selection in daycare surgical settings, where rapid recovery and minimal complications are critical.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patients planned for day care surgeries
  • Patients who have been planned for an elective non head and neck surgical intervention by general anaesthesia
  • American Society of Anaesthesiologist Physical Status I-II.

排除标准

  • V patients Difficult Airway: a) Mallampati class 3 and 4 b) Adentulous patents c) Mouth opening less than 5cm d) Thyromental distance less than 5cm e) Patients with body mass index morethan or equal to
  • Patients known to have risk of gastric aspiration, gastro-esophageal refux disease or hiatus hernia. Pregnancy.

结局指标

主要结局

The Baska Mask’s non-inflatable cuff may offer superior sealing, while the Air-Q with blocker provides easier insertion and dynamic pressure regulation, potentially reducing airway morbidity.

时间窗: Airway sealing pressure and Peak airway pressure after placement. Hemodynamic monitoring at insertion and every 5 min for half hour then every 10 min

次要结局

  • Ease of insertion and postoperative complications(Ease of insertion after placement)

研究者

发起方
Dr Moopens Medical College
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Ranjini M Nair

Dr Moopens Medical College

研究点 (1)

Loading locations...

相似试验