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临床试验/NCT05680909
NCT05680909招募中不适用

Evaluation of SaCo Videolaryngeal Mask Airway for Airway Management and Intubation in Morbidly Obese Anesthetized for Elective Surgery.

Medical University of Lodz1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年5月20日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
1
主要终点
effectiveness of ventillation using SaCo mask in morbidly obese

研究概览

简要总结

SaCo videolaryngeal mask airway is a novel third generation supraglottic device allowing for continuous observation of entrance to larynx via inserted in special channel videoscope connected with cable with external monitor. In obese patients airway management can be difficult so use of new devices that improve safety and potentially efficacy of airway management is indicated. In prospective observational study the SaCo VLM will be evaluated in terms of maintaining airway patency and effectiveness of intubation through it's lumen in morbidly obese scheduled for elective general surgery under general anesthesia.

详细描述

Morbidly obese patients pose challenge to operator when airway management is needed. Additionally they are at increased risk of complications related to failed airway management, hypoxia and following brain injury. SaCo videolaryngeal mask airway is a nowvel third generation supraglottic device allowing for continuous observation of entrance to larynx via inserted in special channel videoscope connected with cable with external monitor. In obese patients airway management can be difficult so use of new devices that improve safety and potentially efficacy of airway management is indicated.

In prospective observational study the SaCo VLM will be evaluated in terms of maintaining airway patency and effectiveness of intubation through it's lumen in morbidly obese scheduled for elective general surgery under general anesthesia.

After induction to general anesthesia SaCo VLM will be inserted with continuous visualisation through camera channel and inserted videoscope and mechanical ventilation will be commenced. Ease of SaCo VLM insertion will be recorded in 5 grade scale: 1- very easy, 2- easy, 3- neutral, 4 - difficult, 5 - very difficult. Time of insertion will be recorded as time from grabbing device and opening of patient's mouth to connecting SaCo VLM to ventilator and confirming of patient's ventilation. Parameters of mechanical ventilation will be recorded: Peak pressure, Lung Compliance - from respirator monitoring system and Seal pressure (measured with following method: fresh gas flow 5 l/min, valve set at 40cmH2O, manual/spontaneuous ventilation mode - with increasing airway pressure when the leak will be recognized achieved maximum pressure will be recorded). The visualisation of entrance to larynx will be assessed on device's monitor in 4-grade scale: 1- best view - all structures of vocal cords visible, 2 - vocal cords partialy visible, 3 - only lower part of entrance to larynx visible, 4 - no visualisation of entrance to larynx). Necessary adjustements will be reorded like external pressure on thyroid cartilage, changing of SaCo VLM mask position. In case of not adequate ventilation following steps will be taken: reposition of SaCo VLM, changing of size of SaCo VLM, endotracheal intubation using videolaryngoscope. After measurements the endotracheal intubation efforts will be commensed under continuous visualisation of entrance to larynx with SaCo VLM videoscope system. Time of intubation will be recorded. Ease of intubation will be recorded in 5 grade scale: 1- very easy, 2- easy, 3- neutral, 4 - difficult, 5 - very difficult. After successful endotracheal intubation confirmed with EtCO2 the standard general anesthesia will continue. After surgery and anesthesia the possible complications will be evaluated: track of blood on device, laryngospasm, sore throat.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • morbid obesity defined as BMI>40 kg/m2
  • scheduled for elective surgery under general anesthesia with endotracheal intubation

排除标准

  • lack of conscent
  • airway abnormalities like for example tumors in mouth, tongue, airway injury,
  • surgery on airway,
  • emergency surgery,

结局指标

主要结局

effectiveness of ventillation using SaCo mask in morbidly obese

时间窗: immediate - right after insertion of SaCo mask

evaluation of ventillation effectiveness indicated by proper ventilation parameters

effectiveness of visualisation of larynx using SaCo VLM in morbidly obese

时间窗: immediate - right after insertion of SaCo VLM

visualisation of entrance to larynx with intergrated SaCo VLM videoscope system - evaluated in 4 grade scale: 1 - best visualisation - all structures of entrance to larynx visible, 4 - only epiglottis visible

seal pressure of SaCo VLM in morbidly obese

时间窗: immediate - right after insertion of SaCo VLM

seal pressure - measured on anesthesia machine

effectiveness of insertion of SaCo VLM for airway management in morbidly obese

时间窗: immediate - right after performing insertion of SaCo mask

evaluation of insertion effectiveness: proper insertion confirmend by presence of EtCO2

次要结局

  • effectiveness of SaCo VLM for endotracheal intubation in morbidly obese(immediate - right after endotracheal intubation through SaCo mask)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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