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临床试验/NCT06103968
NCT06103968已完成不适用

Determining the Influence Gastric Tube Presence in Upholding the Correct Placement of LMA Blockbuster During Surgery.

Aligarh Muslim University1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2023年10月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
66
试验地点
1
主要终点
POGO SCORE

研究概览

简要总结

Since its invention in 1981 by Dr. Archie Brain, the classical laryngeal mask airway (LMA ) has undergone many modifications. Today various LMAs are available that can also help in Ryle's tube insertion, intubation via LMA, deep extubation, adjunct in difficult airway and for spontaneous ventilation in short procedures.

One of the newer modifications is the Blockbuster LMA. It was invented by Prof. Ming Tian, the president of Chinese Difficult Airway Society and is being increasingly used for cases of difficult intubation. It has some unique features like its 95 degrees angulated airway that makes it easier to insert. It also has a gastric port and provides better sealing pressures at lower volumes.

However the one of the major concern with supraglottic airway is that despite correct placement it may dislodge, or its position may change intraoperatively especially in surgeries where patient position needs to be changed or patient is moved/transferred or head and neck surgeries.

In this study investigator wishes to evaluate weather gastric tube inserted through LMA helps in maintaining the LMA blockbuster placement by comparing fibreoptic bronchoscope (FOB) scores recorded immediately after LMA placement and at the end of the surgical procedure.

详细描述

Following approval by the Board of studies, Department of anaesthesiology and ethical committee of this institution the study will be conducted in J N Medical College and hospital on 60 patients undergoing operative procedures under general anaesthesia. Patients will be included in the study after well informed written consent, including the information that they would be part of this ongoing institutional research.

STUDY DESIGN Prospective randomised controlled study

STUDY POPULATION The study will be conducted on 60 patients admitted to JNMCH, AMU Aligarh planned for operative procedure under general anaesthesia.

In this study investigator wishes to evaluate weather gastric tube inserted through LMA helps in maintaining the LMA blockbuster placement by comparing fibreoptic bronchoscope (FOB) scores recorded immediately after LMA placement and at the end of the surgical procedure.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
20 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ASA Grade I & II patients
  • Age between 20-70 years
  • Weight between 40-70 kg
  • Patients of both sexes
  • All classes of MP Grades

排除标准

  • Any pathology of the oral cavity that may obstruct the insertion of device
  • Mouth opening less than 2.5cm.
  • Potentially full stomach patients (trauma, morbid obesity, history of gastric regurgitation and heart burn, full term pregnancy)
  • risk of oesophageal reflux (hiatus hernia)
  • Bleeding disorder
  • Unable to provide informed consent

结局指标

主要结局

POGO SCORE

时间窗: IMMEDIATELY AFTER LMA PLACEMENT AND AT THE END OF SURGERY JUST BEFORE REMOVAL OF LMA

Grading the placement of LMA blockbuster through Fibreoptic Bronchoscope score of at the start and end of the surgery.

次要结局

  • GASTRIC TUBE INSERTION SUCCESS RATE(within 2 minutes of LMA Blockbuster placement)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

MUAZZAM HASAN

Assitant Professor

Aligarh Muslim University

研究点 (1)

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