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临床试验/NCT03892408
NCT03892408已完成不适用

High-flow Nasal Oxygen During Rigid Bronchoscopy Under General Anesthesia: a Randomized Controlled Trial

Yonsei University1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2019年4月21日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
56
试验地点
1
主要终点
the lowest oxygen saturation

研究概览

简要总结

The aim of this study is to evaluate the effect of high-flow nasal cannula oxygen administration on apnea in patients undergoing general anesthesia with rigid bronchoscopy compared with standard anesthesia methods.

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
None

盲法说明

triple (Participant, Care Provider, investigator)

入排标准

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

入选标准

  • •1. Patients undergoing general anesthesia with stent placement or bougination, biopsy or removal of a foreign body or a mass through a rigid bronchoscope
  • •2. Patients aged 19 or older who meet American Society of Anesthesiologists (ASA) physical class 2-4

排除标准

  • •1. Patients with dementia or cognitive impairment
  • •2. pregnant women
  • •3. Patients undergoing extracorporeal membrane oxygenation (ECMO)
  • •4. Patients with active nasal bleeding), severe nasal obstruction, recent nasal trauma of surgery
  • •5. Patients with current maxillofacial trauma or basal skull fracture
  • •6. Patients who had previously undergone rigid bronchoscopy / surgery
  • •7. If the subject includes a person who can not read the written consent (eg, illiterate, foreigner, etc.)

研究组 & 干预措施

Standard

No Intervention

standard anesthesia

Optiflow

Experimental

100 % of oxygen at 70 L / min through Optiflow ™ (Fisher and Paykel Healthcare Limited, Auckland, New Zealand)

干预措施: Optiflow ™ (Device)

结局指标

主要结局

the lowest oxygen saturation

时间窗: apnea period during the rigidbroscopic procedure/surgery

the lowest value of oxygen saturation measured percutaneously at extremity.

次要结局

  • Hypoxia occurs the first time(intraoperative (The time taken to reach the point at which peripheral oxygen saturation fell below 90 for the first time immediately after the onset of apnea))
  • End-tidal carbon dioxide partial pressure(Intraoperative (end-tidal CO2 partial pressure after 3 consecutive breaths after intubation or insertion of laryngeal mask following end of apnea))
  • Arterial oxygen / carbon dioxide partial pressure(shortly after end of apnea (within 30 seconds))
  • hypoxemia related surgical interruptions(4) hypoxemia related surgical interruptions during apneic period)
  • Arterial oxygen / carbon dioxide partial pressure(shortly before start of apnea (within 30 seconds))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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