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临床试验/CTRI/2022/09/045949
CTRI/2022/09/045949尚未招募不适用

Comparison between Laryngeal Mask Airway- Gastro and Low flow nasal Cannula in patients undergoing Upper Gastro-Intestinal Endoscopic procedures under Total Intravenous Anaesthesia: A Randomized Control study

JIPMER1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2022年9月30日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
JIPMER
入组人数
140
试验地点
1
主要终点
To compare success rate of passing endoscopy in the first attempt with LMA gastro and low flow Nasal cannula under TIVA.

研究概览

简要总结

Anaesthesia during gastroenterological procedures is a growing field. While the numbers of patients with severe comorbidities are rising constantly, gastrointestinal endoscopic interventions are moving closer to minimally invasive endoscopic surgery. Various airway techniques have been employed for endoscopic procedures, with an aim to optimise patient outcome by improving airway control and preventing hypoxia whilst avoiding the need for intubation. The LMA gastro is a newer supraglottic airway device, developed specifically for upper gastrointestinal endoscopy and intervention.

Patients undergoing upper Gastro intestinal endoscopy typically receive either Total intravenous anaesthesia(TIVA) or general endotracheal anaesthesia (GETA). Patients receiving propofol based TIVA are at higher risk of sedation related complication. The LMA gastro Airway, a novel dual channel supraglottic airway technique, has a dedicated endoscopy channel which runs parallel along the separate airway channel with terminal cuffs. Use of LMA Gastro helps in avoiding sedation related airway complications like apnea, desaturation and also gives the advantage of initiating rescue measures like positive pressure ventilation without interrupting the endoscopic procedure.

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 60.00 Year(s)(—)
性别
All

入选标准

  • 1} Age 18 to 60 yrs of either sex 2) ASA physical status I and II 3}Elective upper gastro intestinal endoscopic procedure.

排除标准

  • ASA physical status ≥III 2) Hemodynamically unstable patients – Heart rate <60beats per minute and BP <90/60mmHg 3)Patients requiring Endotracheal intubation 4)Patients with anticipated difficult airway.

结局指标

主要结局

To compare success rate of passing endoscopy in the first attempt with LMA gastro and low flow Nasal cannula under TIVA.

时间窗: Baseline

次要结局

  • Endoscopy insertion time(Baseline)
  • interruption of procedure(End of the procedure)
  • Complication(30 minutes after the procedure)
  • Anaesthesiologist satisfaction(Likert scale)
  • Endoscopist satisfaction(Likert scale)

研究者

发起方
JIPMER
申办方类型
Research institution and hospital

研究点 (1)

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