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临床试验/NCT05049395
NCT05049395Unknown不适用

HFNO Reducing the Incidence of Hypoxia During the Procedure of Hysteroscopy Sedated With Propofol,a Randomized, Controlled Trial

RenJi Hospital1 个研究点 分布在 1 个国家目标入组 960 人开始时间: 2021年9月30日最近更新:
适应症

试验速览

阶段
不适用
入组人数
960
试验地点
1
主要终点
The incidence of hypoxia

研究概览

简要总结

To determine whether high-flow nasal cannula oxygen can reduce the incidence of hypoxia during the procedure of sedated hysteroscopy.

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 (Participant)

入排标准

年龄范围
20 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 20 years old ≤ age ≤ 50 years old, female.
  • Undergoing hysteroscopy sedated with propofol for diagnosis or treatment.
  • Informed consent
  • ASA physical status Ⅰ~ Ⅱ.

排除标准

  • Epistaxis, nasal congestion and nasal mucosal damage.
  • Confirmed brain disease (cranial trauma, tumor, stroke, cognitive dysfunction etc.).
  • Confirmed severe heart disease (heart failure, angina pectoris, myocardial infarction, arrhythmia, etc.).
  • Confirmed severe lung diseases (upper respiratory tract infection, asthma, bronchitis, COPD, bullae, pulmonary embolism, pulmonary edema, lung cancer, etc.).
  • Pregnant women.
  • Acute and chronic hepatitis or liver cirrhosis with severe abnormal liver function.
  • Acute and chronic nephritis with severe abnormal renal function or renal failure.
  • Needing oxygen inhalation for underlying diseases.
  • Emergency surgery.
  • Combined with multiple trauma.
  • Allergic to soybean

结局指标

主要结局

The incidence of hypoxia

时间窗: Patients will be followed for the duration of hospital stay, an expected average of 2 hours

75%≤SpO2\<90% and \<60S

次要结局

  • The incidence of sub-clinical respiratory depression(Patients will be followed for the duration of hospital stay, an expected average about 2 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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