跳至主要内容
临床试验/CTRI/2024/05/066672
CTRI/2024/05/066672尚未招募Unknown

To evaluate the efficacy of Baska mask and LMA Protector in anesthetized paralysed patients – a prospective randomized comparative study.

Kalyan Singh Superspeciality cancer institute1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年5月12日最近更新:

试验速览

阶段
Unknown
状态
尚未招募
发起方
入组人数
70
试验地点
1
主要终点
Oropharyngeal leak pressure during positive pressure ventilation.

研究概览

简要总结

The supraglottic airway devices (SGAD) are widely used for airway management in anaesthetic field, critical care and emergency situations like difficult airway management. Since their introduction, several innovative devices have been developed depending on shape, functioning channels and cuff.

Baska maskTM (BM) is novel SGAD with self-sealing membranous cuff that inflates during inspiration and partially deflates during expiration.  It has two drain channels proximally, opening into the large integral sump cavity distally, at the upper oesophagus.

LMA-Protectorâ„¢ is relatively new SGAD with inflatable cuff integrated with Cuff Pilotâ„¢ technology for easier and continuous adjustment of the intracuff pressure. Similar to BM, it has two drain channels which narrows distally into common orifice communicating with the upper oesophageal sphincter.

Both the devices had been evaluated in limited studies. The two devices are similar in design except cuff. BM has got self-sealing cuff while LMA protector has inflatable cuff with continuous monitoring of cuff pressure, so we hypothesize that oropharyngeal sealing pressures might be comparable. Currently, there is no available literature comparing the efficacy of BM with LMA protector.

In our study, we aim to compare BM and LMA protector in terms of clinical efficacy like adequacy of airway seal, insertion time, ease and accuracy of insertion, and the incidence of postoperative sore throat and other complications, in paralyzed and anesthetized patients.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • 18- 65 years all patients Scheduled for elective surgery under general anaesthesia in supine position with expected duration of surgery less than 2 hours.

排除标准

  • Upper airway anatomic variation or pathology.
  • Predicted difficult airway
  • High risk of aspiration (full stomach, gastroesophageal reflux, Pregnancy)
  • Body mass index greater than 30 kg/m2,
  • Patient refusal to participate.

结局指标

主要结局

Oropharyngeal leak pressure during positive pressure ventilation.

时间窗: it will be assessed only once immediately after insertion and once successful ventilation is confirmed.

This outcome measure was used for sample size calculation.

时间窗: it will be assessed only once immediately after insertion and once successful ventilation is confirmed.

次要结局

  • 1. First attempt success rate.(2. Accuracy of size as per manufacturer recommendation.)

研究者

发起方
Kalyan Singh Superspeciality cancer institute
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Ruchi Saxena

Kalyan Singh Superspeciality Cancer Institute

研究点 (1)

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