跳至主要内容
临床试验/CTRI/2023/11/059475
CTRI/2023/11/059475尚未招募Phase 3 4

Comparison Between Baska mask and I-gel for short duration surgeries

NH MMI Narayana Superspeciality Hospital1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2023年11月11日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
80
试验地点
1
主要终点
To measure the oropharyngeal leak pressure between the two devices.

研究概览

简要总结

ACOMPARISON BETWEEN BASKA MASK AND I-GEL

FOR SHORT DURATION SURGERIES

 Patients  undergoing  general anaesthesia  should    have a secured airway  especially in long  duration  surgeries. However,  for shorter surgical  procedures, the  airway can be kept  patent  by the use of  supraglottic  airway devices  without administering  neuromuscular  blockers thus lesser  impact   on patient’s hemodynamic s  and  lesser  trauma  to airway.  Also  these  devices  have high  airway seal  pressure with low  resistance  to gas flow , low  incidence ofaspiration  and complications .  These  are  divided  into  first , second  and third  generation airway  devices. The newest include Baska mask   and  I-GEL which  have  a cuffless sealing  mechanism due to its thermoelastic material  which  can expand on heat , also   preventing  injury  to airway  and problems  of maintaining  sealing  pressure . Both devices have an airwaychannel separate from gastric channel  toprovide  additional safety inlaparoscopic  surgeries . They  also have  laryngoprotective    properties.

I-GEL which is a second generation supraglottic airwaydevice made from styrene-ethylene- butylene. It has an additional bite block.It is also comparable to LMAs and proseal LMAs in insertion rates and sealingpressures.

Baska mask, introduced by Kanag and Meena Baska , a 3rdgenerational airway with one gastric channel and a pharyngeal channel with abite block. Various studies and journals supporting this thesis work has beendone . Studies have also been perfomed on laparoscopic surgeries , minorurological  and gynaecologicalprocedures, in obese and spontaneously ventilating patients.

Shamugavelu et al. conducted a study comparing both i-Geland Baska mask in laparoscopic surgeries and concluded that both airways arecomparable with each other in larascopic surgeries and i-Gel is quicker toinsert whilst Baska gave a good airway seal.

Our study will compare Insertion time,Number of attempts required to insert, oropharyngeal leak pressure between thetwo devices. We will also assess hemodynamic stability of the patient andanalyse intraoperative and post operative airway related complications.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Not Applicable

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • 1.ASA I and II patients 2.Mallampati grade 1 and 2.

排除标准

  • 1.Patients with ASA III or above 2.anticipated difficult airway 3.patients with increased aspiration risk 4.BMI >30kg/m2.

结局指标

主要结局

To measure the oropharyngeal leak pressure between the two devices.

时间窗: To measure the oropharyngeal leak pressure between the two devices immediately after insertion and 30 mins after insertion | 2. Insertion time | 3. Number of attempts required to insert

2. Insertion time

时间窗: To measure the oropharyngeal leak pressure between the two devices immediately after insertion and 30 mins after insertion | 2. Insertion time | 3. Number of attempts required to insert

3. Number of attempts required to insert

时间窗: To measure the oropharyngeal leak pressure between the two devices immediately after insertion and 30 mins after insertion | 2. Insertion time | 3. Number of attempts required to insert

次要结局

  • 1 To assess hemodynamical parameters of the patient(2 To analyse intraoperative & post operative airway related complications)

研究者

发起方
NH MMI Narayana Superspeciality Hospital
申办方类型
Research institution and hospital

研究点 (1)

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