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临床试验/NCT04767867
NCT04767867已完成不适用

Pre-oxygenation With Facemask Oxygen vs High-flow Nasal Oxygen vs High-flow Nasal Oxygen Plus Mouthpiece Oxygen - a Randomised Controlled Trial

University College Hospital Galway1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2020年8月1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
84
试验地点
1
主要终点
Time to oxygen desaturation

研究概览

简要总结

Pre-oxygenation increases oxygen reserves in the body to reduce the likelihood of oxygen desaturation on induction of general anaesthesia. Pre-oxygenation with facemask is the commonest method method of pre-oxygenation. High-flow nasal oxygen is a newer alternative. This study randomises participants to receive pre-oxygenation by one of three methods: facemask, high-flow nasal oxygen, high-flow nasal oxygen plus mouthpiece.

详细描述

The administration of supplemental oxygen prior to induction of anaesthesia is known as pre-oxygenation. Pre-oxygenation increases oxygen reserves in the body with the purpose of delaying the time until oxygen desaturation after breathing stops (apnoea) following the administration of an anaesthetic. In the last decade, clinicians have begun utilising high-flow nasal oxygen for pre-oxygenation. However, the rationale for this is based largely on its ability to achieve ongoing oxygenation after the onset of apnoea (apnoeic oxygenation). This study isolates oxygen administration with high-flow nasal oxygen to the period when the person is breathing, without ongoing oxygen administration during the apnoea period, to quantify its effects during the pre-oxygenation period only. A third group of participants breathes oxygen through a mouthpiece in addition to receiving oxygen via high-flow nasal cannulae. The effect of these pre-oxygenation methods will be measured by the time taken until oxygen saturation levels decline to the lower end of the normal range (92%), along with other parameters such as blood oxygen levels.

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.

结局指标

主要结局

Time to oxygen desaturation

时间窗: Immediately after the intervention

The time period from the onset of apnoea (determined by visual inspection) until an oxygen saturation of 92% is measured by pulse oximetry.

次要结局

  • Correlation between end-tidal carbon dioxide measurement and arterial partial pressure of carbon dioxide(Etco2 obtained at the time of resumption of ventilation. Paco2 obtained from the preceding blood gas measurement.)
  • Change in acid-base status during apnoea(At 0, 1, 2 minutes and each 2 minutes thereafter)
  • Arterial partial pressure of oxygen after pre-oxygenation.(At 3 minutes of pre-oxygenation)
  • Arterial partial pressure of carbon dioxide change during pre-oxygenation(At 0 and 3 minutes)
  • Change in arterial partial pressure of carbon dioxide during apnoea(At 0, 1, 2 minutes and each 2 minutes thereafter)

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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