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临床试验/NCT03195504
NCT03195504已完成不适用

Effectiveness of Apneic Oxygenation Using High-flow Nasal Cannula in Morbidly Obese Patients Undergoing General Anesthesia

University Health Network, Toronto1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2017年8月10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
40
试验地点
1
主要终点
Measurement of safe apnea time

研究概览

简要总结

Before going off to sleep patients are given oxygen to saturate blood with oxygen to extend time before a decrease in the level of oxygen in the blood occurs. During this period, obese patients have a faster decrease in the level of oxygen in their blood. This study uses a device called "high-flow nasal cannula" (HFNC), which delivers humidified high-flow oxygen through 2 small plastic tubes placed just inside nostrils. In the intensive care unit settings this device has been used extensively and has become a standard practice. Purpose of this study is to determine whether these high-flow nasal cannula increase the time safely when going to sleep during elective surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

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

入选标准

  • •Age more than18 years old
  • •ASA status I-III
  • •Elective surgery performed under general anesthesia requiring endotracheal intubation
  • •BMI more than 40 kg/m2

排除标准

  • •Chronic respiratory disease
  • •SpO2 <98% after supplementing oxygen
  • •Previous or anticipated difficult intubation
  • •Uncontrolled hypertension
  • •Ischemic heart disease
  • •Congestive heart failure
  • •Increased intracranial pressure
  • •Uncontrolled GERD
  • •Known allergy or contraindication to anesthesia drugs
  • •Nasal blockade contraindicating the use of HFNC

研究组 & 干预措施

HFNC (High Flow Nasal Cannulae)

Experimental

High Flow Nasal Cannulae providing humidified, high-flow oxygen during induction of anesthesia

干预措施: HFNC (Device)

CON (control)

Active Comparator

Standard flow oxygen during induction of anesthesia

干预措施: CON (control) (Device)

结局指标

主要结局

Measurement of safe apnea time

时间窗: Maximum up to 6 minutes

Safe apnea time, defined by time to desaturation (SpO2 \> 95%) or apnea maximum up to 6 minutes

次要结局

  • Highest EtCO2(Every minute up to 5 minutes on commencing ventilation)
  • Time to regain baseline SpO2(Up to 5 minutes after intubation)
  • Lowest SpO2(Every minute up to 5 minutes after intubation)

研究者

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

David Wong

Professor Anesthesia (MD)

University Health Network, Toronto

研究点 (1)

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