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临床试验/NCT04772183
NCT04772183招募中不适用

OxyGap : Comparison Between Different Pulse Oximeter and With the Arterial Blood

Laval University2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2021年3月24日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
300
试验地点
2
主要终点
Diffence between Masimo SpO2 and the SaO2 value

研究概览

简要总结

The oximeter is used to monitor intensive care patients undergoing oxygen therapy. It indicates pulsed oxygen saturation (SpO2), a reflection of arterial oxygen saturation (SaO2) which enables detection of hypoxemia and hyperoxia, both deleterious state. Current SpO2 recommendations aim to reduce both risk of hypoxemia and hyperoxia. SpO2 is considered the 5th vital sign.

Current recommendations for SpO2 targets do not consider the variability of oximeters used in clinical practice. This variability and lack of specification represent an obstacle to an optimal practice of oxygen therapy.

Thus, this study aims to compare the SpO2 values of different oximeters (Nonin, Masimo, Philips, Nellcor) used in clinical practice with the SaO2 reference value obtained by an arterial gas in order to specify the precision and the systematic biases of the oximeters studied. This data will also make it possible to refine the recommendations concerning optimal oxygenation

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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 old
  • Patients admitted to the Intensive Care Unit
  • Artery catheter already installed

排除标准

  • No signal with the oximeter
  • Pigmented nails or nail polish
  • Methemoglobinemia
  • Patient in isolation (multi-resistant bacteria, C-Difficile, COVID-19...)
  • Prone position

结局指标

主要结局

Diffence between Masimo SpO2 and the SaO2 value

时间窗: During arterial blood gase sample

Diffence between Masimo oximeter SpO2 and the SaO2 value

Diffence between Nellcor SpO2 and the SaO2 value

时间窗: During arterial blood gase sample

Diffence between Nellcor oximeter SpO2 and the SaO2 value

Diffence between Nonin ear clip and the SaO2 value

时间窗: During arterial blood gase sample

Diffence between Nonin (ear sensor) oximeter SpO2 and the SaO2 value

Diffence between Philips SpO2 and the SaO2 value

时间窗: During arterial blood gase sample

Diffence between Philips oximeter SpO2 and the SaO2 value

Diffence between FreeO2 SpO2 and the SaO2 value

时间窗: During arterial blood gase sample

Diffence between Nonin (FreeO2) oximeter SpO2 and the SaO2 value

Diffence between Contec SpO2 and the SaO2 value

时间窗: During arterial blood gase sample

Difffence between Contec oximeter SpO2 and the SaO2 value

Diffence between Bejing choice SpO2 and the SaO2 value

时间窗: During arterial blood gase sample

Diffence between Bejing choice oximeter SpO2 and the SaO2 value

次要结局

  • Hyperoxemia detection(During arterial blood gase sample)
  • Gaps between the different oximeters(During arterial blood gase sample)
  • Overestimation and underestimation of SaO2(During arterial blood gase sample)
  • Hypoxemia detection(During arterial blood gase sample)
  • Finger and ear sensor comparison(During arterial blood gase sample)

研究者

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

François Lellouche

Principal investigator

Laval University

研究点 (2)

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