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临床试验/NCT03905733
NCT03905733Unknown不适用

The Effects of High-flow Nasal Oxygen on Oxygenation During Rigid Bronchoscopy Under General Anesthesia in Pediatric Patients: A Prospective Observational Pilot Study

Yonsei University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年4月最近更新:
适应症

试验速览

阶段
不适用
入组人数
20
试验地点
1
主要终点
Hypoxia occurs the first time

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 maintenance of oxygenation and removal of carbon dioxide during apnoeic period in pediatric patients undergoing general anesthesia with rigid bronchoscopy

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
— 至 7 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing general anesthesia with stent placement or bougination, biopsy or removal of a foreign body or a mass through a rigid bronchoscope
  • Patients aged 7 or younger who meet American Society of Anesthesiologists (ASA) physical class 2-4

排除标准

  • Patients undergoing extracorporeal membrane oxygenation (ECMO)
  • Patients with active nasal bleeding), severe nasal obstruction, recent nasal trauma of surgery
  • Patients with current maxillofacial trauma or basal skull fracture
  • Patients with active nasal bleeding), severe nasal obstruction, recent nasal trauma of surgery
  • Extremely low birth weight infant and premature infant less than 28 weeks gestation age
  • Patients who had previously undergone rigid bronchoscopy / surgery
  • If the parent of subject includes a person who can not read the written consent (eg, illiterate, foreigner, etc.)

结局指标

主要结局

Hypoxia occurs the first time

时间窗: 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 intraoperatively.

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

the lowest oxygen saturation

时间窗: apnea period during the rigidbroscopic procedure/surgery

the lowest value of oxygen saturation measured percutaneously at extremity.

Occurence of hypoxic event

时间窗: apnea period during the rigidbroscopic procedure/surgery

Occurence of hypoxic event: Presence or absence of hypoxia(peripheral oxygen saturation fell below 90% ) during rigid bronchoscopy

次要结局

  • End-tidal carbon dioxide partial pressure(end-tidal CO2 partial pressure after 3 consecutive breaths after intubation or insertion of laryngeal mask following end of apnea during intraoperative period.)
  • Arterial oxygen / carbon dioxide partial pressure(shortly before start of apnea (within 30 seconds) and shortly after end 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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