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临床试验/NCT03028688
NCT03028688已完成不适用

HIFLO ENDO- Use of High Flow Nasal Cannula Oxygenation to Increase Patient Safety During Upper GI Endoscopy

University of Maryland, Baltimore2 个研究点 分布在 1 个国家目标入组 262 人开始时间: 2017年6月21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
262
试验地点
2
主要终点
Hypoxemia event (Low blood oxygen level)

研究概览

简要总结

Millions of patients undergo upper GI endoscopy in the United States each year. A large number of these patients have anesthesia to assist with their comfort during the procedure. The majority of patients do not have a protected airway during the procedure, meaning there is no endotracheal tube. Instead the current standard of care is to give supplementary oxygen via nasal cannula. Because patients are deeply sedated or have general anesthesia there is a risk for low oxygen saturation during the procedure, which presents a significant patient safety issue. The purpose of the clinical trial is compare the current anesthesia standard of care against high flow nasal cannula oxygen delivery during anesthesia. The investigator's hypothesis is that high flow nasal cannula oxygen delivery will decrease the frequency with which patients experience hypoxemia during anesthesia for upper GI endoscopy.

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
Single (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

  • Having Upper GI endoscopy expected to last greater than 15 minutes with anesthesia.
  • Age greater than or equal to 18 years

排除标准

  • Propofol, midazolam, or fentanyl allergy
  • Pre-procedure plan for general anesthesia with an endotracheal tube (at the discretion of the attending anesthesiologist)
  • Any procedure with planned electro-cautery as a high-inspired oxygen concentration could increase the risk for airway or esophageal fire.

结局指标

主要结局

Hypoxemia event (Low blood oxygen level)

时间窗: The outcome variable will be measured one time 24 hours after the completion of the patient's anesthesia.

The primary outcome measure will be occurrence of a low blood oxygen level defined by oxygen saturation less than 92% for greater than 15 seconds at any point during the patient's anesthesia. This will be a dichotomous outcome variable analyzed by time to event.

次要结局

  • Hypercarbia event (Elevated blood CO2 level)(The outcome variable will be measured one time 24 hours after the completion of the patient's anesthesia.)
  • Hypotension event (Low blood pressure)(The outcome variable will be measured one time 24 hours after the completion of the patient's anesthesia.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael Mazzeffi

Assistant Professor of Anesthesiology

University of Maryland, Baltimore

研究点 (2)

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