跳至主要内容
临床试验/CTRI/2018/07/014774
CTRI/2018/07/014774尚未招募1 期

COMPARISON OF EFFECTS OF LARYNGEAL MASK AIRWAY (LMA) SUPREME CUFF INFLATION WITH AIR, AIR: OXYGEN MIXTURE AND OXYGEN: NITROUS OXIDE MIXTURE IN ADULTS: A RANDOMIZED DOUBLE BLIND STUDY

Govt Medical College Amritsar1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2018年12月7日最近更新:

试验速览

阶段
1 期
状态
尚未招募
发起方
入组人数
120
试验地点
1
主要终点
To compare the changes in cuff pressure intraoperatively with different gas composition (Air, Air: Oxygen mixture, Oxygen: Nitrous oxide mixture) used to inflate the LMA Supreme by cuff pressure monitor.(Manometer)

研究概览

简要总结

The laryngeal mask airway is one of the airway devices that has gained popularity during the past decade.LMA cuff inflation with the normal recommended injection volume results in the residual volume of the cuff being exceeded during anaesthesia resulting in severe and even fatal injury including tracheal pain or stridor.  A variety of   media are used for cuff inflation which varies with their efficacy to maintain a stabilised cuff pressure and to prevent post intubation-related emergence phenomenon. This will be a prospective randomized double blind study which will be done to compare the effects of laryngeal mask airway (LMA) supreme cuff inflation with air, air: oxygen mixture and oxygen: nitrous oxide mixture in adults. The study will be carried out on 120 adults of ASA grade I and II who will be divided into three groups of 40 each. Supreme LMA cuff inflation will use Air only in group A, Oxygen: Air mixture in Group OA andOxygen: Nitrous oxide mixture in Group ON. All the groups will be compared with respect to changes in cuff pressure intraoperatively with different gas composition used to inflate the LMA Supreme with a manometer and

post-operative pharyngolaryngeal morbidity. The observations will be recorded on the proforma and the results will be statistically analysed in the three groups.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Double Blind Double Dummy

入排标准

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

入选标准

  • ASA Grade I and II Age 18 to 60.

排除标准

  • Inadequate mouth opening
  • Patient with BMI > 35 kg/m2
  • Anticipated difficult airway.
  • Patient having diseases with risk of aspiration like gastro oesophageal reflux disease, hiatus hernia.
  • Oropharyngeal pathology
  • ASA grading III, IV
  • Cervical spine pathology 8.

结局指标

主要结局

To compare the changes in cuff pressure intraoperatively with different gas composition (Air, Air: Oxygen mixture, Oxygen: Nitrous oxide mixture) used to inflate the LMA Supreme by cuff pressure monitor.(Manometer)

时间窗: The primary outcome will be compare the changes in cuff pressure intraoperatively with different gas composition (Air, Air: Oxygen mixture, Oxygen: Nitrous oxide mixture) used to inflate the LMA Supreme by cuff pressure monitor.(Manometer)

次要结局

  • a. To compare the effect of LMA Supreme cuff pressure change on intraoperative(ventilator parameters)

研究者

发起方
Govt Medical College Amritsar
申办方类型
Government medical college

研究点 (1)

Loading locations...

相似试验