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临床试验/NCT05046223
NCT05046223已完成不适用

Analysis of Intraoperative Homeostasis and Postoperative Recovery After Interventional Bronchoscopy With Different Anesthetic Management

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2021年8月20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
160
试验地点
1
主要终点
response to spraying local anesthetics by bronchoscopy

研究概览

简要总结

THRIVE and iGEL were applied for maintain oxygenation in bronchoscopic interventions which could not performed with an endotracheal tube. However, besides the risk of desaturation, the differences on difficulties to approach vocal cords, the responses to spay of local anesthetics including cough or spasm, the CO2 elimination, the hemodynamic changes, and the effects on postoperative recovery are rarely investigated.

详细描述

THRIVE and iGEL were applied for maintain oxygenation in bronchoscopic interventions which could not performed with an endotracheal tube. Unlike the nasal cannula with THRIVE, the tips of iGel are located in upper esophagi, it may affect the postoperative swallowing, especially for the aged group. However, the bronchoscopic approach may be easier for an established route to vocal cords. With shared airway for ventilation and interventions, CO2 elimination is hardly monitored besides the risk of desaturation.

In this study, THRIVE or iGel was planned to be randomized used for bronchoscopic interventions in an adult group (age 20-65) and an aged group (age over 65). The difficulties to approach vocal cords, the responses to spay of local anesthetics including cough or spasm, the CO2 elimination, the hemodynamic changes, and the effects on postoperative recovery are compared between THRIVE and iGel groups.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

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

入选标准

  • plan to receive bronchoscopic interventions with total intravenous anesthesia

排除标准

  • awake bronchoscopy pregnancy

结局指标

主要结局

response to spraying local anesthetics by bronchoscopy

时间窗: from visualizng vocal cords to complete local anesthetic spray in trachea and main bronchi

the status of vocal cords visualized (relaxed, closed, relaxed but close with spray of local anesthetics); cough scale during bronchoscopic insertion and spray of local anesthetics

difficulty of bronchoscopic approach

时间窗: from bronchoscopic insertion to visualize vocal cords

time from insertion to visualize vocal cord, records of manipulations if applied

次要结局

  • hemodynamic changes(from bronchoscopic insertion to 20 minutes after completion of local anesthetic spraying)
  • cough scale(from bronchoscopic insertion to the end of procedure)
  • postanesthetic recovery(from admission to PACU to discharge from PACU)
  • SPO2(every 5 minutes from bronchoscopic insertion to the end of procedure)
  • Transdermal CO2(every 5 minutes from bronchoscopic insertion to the end of procedure)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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