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临床试验/NCT04814628
NCT04814628已完成不适用

Contribution of Transnasal Humidified Rapid-insufflation Ventilatory Exchange (THRIVE) to Optimize Maternal Pre-oxygenation and Anaesthetic Preparation Time for General Anaesthesia for Urgent Caesarean Section A Prospective Experimental Study on Healthy Volunteers.

Hospices Civils de Lyon2 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2024年2月15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
1
试验地点
2
主要终点
time between when the volunteer enters the operating room and when the conditions for general anesthesia are met during pre-oxygenation

研究概览

简要总结

The main objective of this study is to determine if the use of transnasal humidified rapid-insufflation ventilatory exchange (THRIVE) can reduce by 90 seconds the time between the entry into the operating room of the volunteer and the moment when the anaesthetic drugs are ready and when the Oxygen Reserve Index has reached a plateau value for more than 10 seconds, a moment which would therefore allow the induction of general anaesthesia, compared to the pre-oxygenation with the face mask applied by the anaesthetist alone in charge of anaesthesia.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

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

入选标准

  • affiliated to a social security scheme or beneficiary of such a scheme
  • having voluntarily and informedly agreed to participate in the study.
  • non-smoker
  • free from pulmonary, cardiac and neurological pathologies
  • have a normal functional respiratory test at baseline.

排除标准

  • refusal to participate in the study
  • non-French speaking volunteer
  • obesity defined by a body mass index greater than 30 kilogram/meter² (kg/m²)
  • current pregnancy
  • Volunteer in period of exclusion from further research
  • Person under guardianship, curatorship or any other administrative or judicial measure of deprivation of rights and liberty

结局指标

主要结局

time between when the volunteer enters the operating room and when the conditions for general anesthesia are met during pre-oxygenation

时间窗: through study completion, an average of 1 year

Difference between the time when volunteer enters the operating room and the time when the conditions for general anaesthesia are met during pre-oxygenation with the face mask applied by one anaesthesist in charge of the volunteer (simulated patient) compared to the use of preoxygenation with THRIVE by one anaesthesist in charge of the volunteer

次要结局

  • number of medication errors during the preparation(through study completion, an average of 1 year)
  • number of deviations from appropriate anaesthetic practices observed during preparation(through study completion, an average of 1 year)
  • time between volunteer enters the operating room and when the conditions for general anaesthesia are met during pre-oxygenation(through study completion, an average of 1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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