Comparison of Pulse Oximetry (SpO2) With Different Oximeters and Arterial Saturation (SaO2): Oxygap2 Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 3
- 主要终点
- Difference between Nellcor oximeter SpO2 value and the SaO2 value on arterial blood gases
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 (General Electric-GE, Medtronic, Masimo and Nonin) 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
- 0 Years 至 100 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 18 years old (adult population) -
- •Patients admitted to the Intensive Care Unit
- •Artery catheter already installed
- •Pediatric population
- •Below 18 years old
- •Patients admitted to the Intensive Care Unit
- •Artery catheter already installed
排除标准
- •No or poor signal with the usual pulse oximeter/based on clinician judgment
- •High dose of vasopressors or inotropes (epinephrine or norepinephrine ˃ 1mcg/kg/min), shock state (lactates above 3 mmoles/L)
- •Pigmented nails or nail polish
- •Methemoglobinemia history
- •Hemoglobin below 80 g/L
- •Patient in isolation (multi-resistant bacteria, C-Difficile, SARS-COV-2…)
- •Prone position, Extra Corporel Membrane Oxygenator
结局指标
主要结局
Difference between Nellcor oximeter SpO2 value and the SaO2 value on arterial blood gases
时间窗: During procedure (arterial blood gassample collection)
Difference between Nellcor oximeter SpO2 and the SaO2 value
Difference between GE oximeter SpO2 value and the SaO2 value on arterial blood gases
时间窗: During procedure (arterial blood gas sample collection)
Difference between GE oximeter SpO2 and the SaO2 value
Difference between Masimo oximeter SpO2 value and the SaO2 value on arterial blood gases
时间窗: During procedure (arterial blood gas sample collection)
Difference between Masimo oximeter SpO2 and the SaO2 value
Difference between Nonin oximeter SpO2 value and the SaO2 value on arterial blood gases
时间窗: During procedure (arterial blood gas sample collection)
Difference between Nonin oximeter SpO2 and the SaO2 value
次要结局
- Hypoxemia detection(During procedure (arterial blood gas sample collection))
- Overestimation and underestimation of SaO2(During procedure (arterial blood gas sample collection))
研究者
François Lellouche
Principal Investigator
Laval University