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临床试验/NCT05124093
NCT05124093已完成不适用

A Randomised Controlled Trial of Apnoeic Oxygenation With No-flow vs High-flow vs Ultra High-flow Nasal Oxygen

University College Hospital Galway1 个研究点 分布在 1 个国家目标入组 114 人开始时间: 2021年11月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
114
试验地点
1
主要终点
Rise in arterial partial pressure of carbon dioxide

研究概览

简要总结

Apnoeic oxygenation refers to oxygenation that occurs through the insufflation of oxygen into the lungs in the absence spontaneous respiration or positive pressure ventilation. It is used to extend the time to desaturation at induction of anaesthesia and as a primary oxygenation technique during airway surgery. The impact of high-flow nasal oxygen flow rate selection on gas exchange is poorly understood. Participants in this study will be randomised to receive a certain nasal oxygen flow rate during apnoea and its effect on gas exchange will be measured by blood gas analysis.

详细描述

Apnoeic oxygenation with high-flow nasal oxygen has been proposed to result in carbon dioxide clearance. However, this has been poorly quantified.

This study will compare use of nasal oxygen at different flow rates during apnoea with that of a control that does not receive nasal oxygen. Participants are anaesthetised after standardised pre-oxygenation with high-flow nasal oxygen, after which they will receive one of three nasal oxygen flow rates (0, 70, 120 L/min).

The rate of carbon dioxide elevation will be measured by arterial blood gas analysis after the onset of apnoea and compared between the three groups to discern the relative rates of carbon dioxide clearance after the first minute of apnoea. The effect of nasal oxygen flow rate on oxygenation will also be measured.

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
None

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

  • 18 years of age or older
  • ASA 1 or 2
  • Receiving a general anaesthetic for non-emergent surgery

排除标准

  • ASA score ≥3
  • BMI ≥ 30 kg/m2
  • Nasal obstruction
  • Baseline SpO2 ≤95% on room air
  • Anticipated difficult airway management
  • Requirement for awake intubation
  • Pregnancy
  • Positive PCR test for coronavirus in preceding 14 days.

结局指标

主要结局

Rise in arterial partial pressure of carbon dioxide

时间窗: Between 1 and 4 minutes of apnoea

The rate of rise of the partial pressure of carbon dioxide between 60 seconds and 240 seconds of apnoea as measured by arterial blood gas analysis.

次要结局

  • Time to oxygen desaturation(Immediately after the intervention)
  • Partial pressure of oxygen during apnoea(Following high-flow nasal oxygen administration)
  • Change in carbon dioxide elevation before and after HFNO administration(Between 3 and 5 minutes of apnoea)
  • Carbon dioxide elevation during the first minute of apnoea(Between 0 and 1 minute of apnoea)
  • Change in acid-base status during apnoea(At 1 minute intervals during apnoea)

研究者

发起方
University College Hospital Galway
申办方类型
Other
责任方
Principal Investigator
主要研究者

John Laffey

+Michael Callaghan - principal investigator

University College Hospital Galway

研究点 (1)

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