跳至主要内容
临床试验/CTRI/2022/06/043121
CTRI/2022/06/043121尚未招募4 期

Safety and Efficacy of Laryngeal Mask Airway Placement in Term of Oropharyngeal Leak Pressure : A Comparison between ConventionalInsertion and Laryngoscope Guided Insertion

Bankura Sammilani Medical College1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年6月15日最近更新:

试验速览

阶段
4 期
状态
尚未招募
入组人数
100
试验地点
1
主要终点
OPLP, time taken for insertion, whether first attempt successful, Post LMA removal adverse events

研究概览

简要总结

Laryngeal Mask Airway is most commonly used supraglottic airway devices, it is routinly used by conventional/blind technique.It can also be introduced by laryngoscope guidance.The degree of airway protection or sealing in LMA can be determine from clinical sign such as Oropharyngeal Leak PreSsure (OPLP) or Fiberoptic Scoring...Here OPLP  is considering better clinical performance or function of the LMA than Fiberoptic scoring system..Higher OPLP is desirable as they indicate the feasibility of positive pressure ventilation and the likelihood of supraglottic airway placement.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant and Investigator Blinded

入排标准

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

入选标准

  • •Patients aged between 19-70years of each sex •Patients belonging to ASA physical status Grade I and II.
  • •Patients planned for elective general surgery, urosurgery, gynae-obstetrics& orthopedic surgery under general anaesthesia with Laryngeal Mask Airway.

排除标准

  • •Patient not giving consent.
  • •Recent history of upper respiratory tract infection •Contraindications of use of LMA such as body mass index(BMI) ≥ 40 kg/m2 •patients who are at an increased risk of gastric aspiration-the patient with a history of obesity, hiatal hernia, gastroparesis or trauma •An inability to open the mouth or an infection or pathologic abnormality within the oral cavity or pharynx, •Disease like-Bronchospasm, pulmonary edema •Any acute injury or trauma patient.

结局指标

主要结局

OPLP, time taken for insertion, whether first attempt successful, Post LMA removal adverse events

时间窗: 6 months

次要结局

  • Hemodynamic parameters will be recorded at baseline, 1 min after anaesthesia induction, before insertion of the LMA, and 1 min after insertion of the LMA(6 months)

研究者

申办方类型
Government medical college

研究点 (1)

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