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临床试验/NCT03591432
NCT03591432Unknown不适用

A Randomised Controlled Trial Comparing Transnasal humidified Rapid insufflation Ventilatory Exchange (THRIVE) Pre-oxygenation and Apneic Oxygenation With Facemask Pre-oxygenation and Ventilation in Elderly Patients Undergoing Induction of Anaesthesia.

Tao Zhang1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2018年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
200
试验地点
1
主要终点
Postoperative respiratory complications

研究概览

简要总结

Induction of general anaesthesia in patients undergoing emergency surgery can be challenging, because of the often suboptimal circumstances under which anaesthesia has to be delivered, as well as potential physiological derangements caused by their underlying illness, especially in elderly patients. Pre-oxygenation is usually achieved using oxygen delivered via a facemask before induction of anaesthesia. In patients undergoing elective surgery, the lungs are normally ventilated with a bag/facemask technique after induction. However, these options for oxygenation are limited. Facemask ventilation has a perceived risk of gastric insufflation of gas, leading to increased intragastric pressure and raised risk of pulmonary aspiration of stomach contents. Nasal cannulae have been recommended as an alternative method of delivering continuous oxygen during induction of anaesthesia. The Aim of this study is to compare the effect of transnasal humidified rapid insufflation ventilatory exchange (THRIVE) oxygenation with facemask oxygenation on extended apnoeic period and postoperative respiratory complications in elderly patients undergoing induction of anaesthesia.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
65 Years 至 100 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who required induction of general anaesthesia for emergency surgery, whose routine clinical care required arterial blood gas sampling, and who were competent to give consent were recruited.

排除标准

  • Patients who had severe respiratory disease.

研究组 & 干预措施

THRIVE

Experimental

Using transnasal humidified rapid insufflation ventilatory exchange (THRIVE) oxygenation technique in elderly patients undergoing induction of anesthesia.

干预措施: Transnasal humidified rapid insufflation ventilatory exchange (THRIVE) (Device)

Facemask

Active Comparator

Using facemask technique in elderly patients undergoing induction of anesthesia.

干预措施: Facemask ventilation (Device)

结局指标

主要结局

Postoperative respiratory complications

时间窗: 14 days after surgery

Extended apnoeic period

时间窗: during induction of anesthesia

次要结局

未报告次要终点

研究者

发起方
Tao Zhang
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Tao Zhang

Associate Professor

First Affiliated Hospital, Sun Yat-Sen University

研究点 (1)

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