Comparison of Two Oxygenation Targets With Two Different Oximeters - Impact on Oxygen Flow Rates and Oxygenation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Oxygen flow (or FiO2)
研究概览
简要总结
The investigators recently evaluated 4 different oximeters among the most commonly used with arterial catheter in place and compared SpO2 with SaO2 obtained on arterial gas. Correlations between SaO2 and SpO2 were poor for all oximeters, as previously known, and SpO2-SaO2 bias were different between oximeters. Some oximeters (Masimo, Nellcor) had lower biases but they detected less well hypoxemia. Some oximeters underestimated SaO2 (Nonin) but detected very well hypoxemia, and some overestimated SaO2 (Philips). The investigators concluded that oximeters provide different informations to clinicians, and oxygenation targets should take into account for these differences.
The assumption is that the SpO2 target AND oximeter used will both have an impact on oxygen flows and that these effects will add up. With a high SpO2 target, oxygen flows will be significantly greater and with the Nonin oximeter, the required flows will be greater than with the Philips oximeter.
NB: the results obtained were in a population with light skin pigmentation (96% of the patients were Fitzpatrick 1-2, reflecting the local hospitalized population).
详细描述
The oximeters to be evaluated will be the Nonin (Plymouth, MN), and the Philips (Eindhoven, Netherlands). The sensors used will be digital reusable sensors for all oximeters. Because of the impact of the fingers used for SpO2 measurement, each oximeter will be randomly assigned a different finger to each patient (digit 2 and 3 on the hand opposite to the arterial catheter).
Two SpO2 targets will be assessed: 90% and 94%. A total of four 10-minute periods will be performed in randomized order: Nonin 90, Nonin 94, Philips 90, and Philips 94.
At the end of each 10-minute period, arterial gas will be collected through the arterial catheter.
The adjustment of the oxygen flow rates will be performed manually. The average oxygen flow of the last 2 minutes of the period will be considered.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 18 years of age
- •Patients admitted to postoperative cardiac surgery intensive care unit
- •Presence of an arterial catheter Specific for the extubate patient
- •Ongoing on conventional oxygen therapy at moderate flow (up to a maximum of 5L/min) with SpO2 between 88 and 100% with the usual oximeter and nasal cannula.
- •SpO2 < 92% ambient air Specific for the intubate patient FiO2 <= 0.60 with SpO2 between 88 and 100% with usual oximeter SpO2 < 92% with FiO2 0.21
排除标准
- •No SpO2 signal with oximeter in use
- •False nails or nail polish
- •Methemoglobinemia >0.015 on last available arterial gas
- •Patient in isolation (multi-resistant bacteria, C-Difficile, SARS-CoV-2 ...) Specific for the extubate patient
- •Expected to use another respiratory support within one hour of inclusion (NIV or nasal high flow oxygen) Planned extubation within one hour of inclusion
研究组 & 干预措施
Nonin oximeter with a 90% SpO2 target
During this periods , oxygen will be administered in an manual titration with the FreeO2 device (fixed flow mode) to reach 90% of SpO2.
干预措施: Manual oxygen titration with Nonin oximeter (SpO2 target 90%) (Device)
Philips oximeter with a 90% SpO2 target
During this periods, oxygen will be administered in a manual titration with the FreeO2 device (fixed flow mode), to reach 90% of SpO2.
干预措施: Manual Oxygen titration with Philips oximeter (SpO2 target 90%) (Device)
Nonin oximeter with a 94% SpO2 target
During this periods , oxygen will be administered in a manual titration with the FreeO2 device (fixed flow mode) to reach 94% of SpO2.
干预措施: Manual oxygen titration with Nonin oximeter (SpO2 target 94%) (Device)
Philips oximeter with a 94% SpO2 target
During this periods, oxygen will be administered in a manual titration with the FreeO2 device (fixed flow mode), to reach 94% of SpO2.
干预措施: Manual Oxygen titration with Philips oximeter (SpO2 target 94%) (Device)
结局指标
主要结局
Oxygen flow (or FiO2)
时间窗: Mean Oxygen flow in the two last minute of each study period (between minute 8 and 10)
Oxygen flows (or FiO2) at the end of each study period (last minute average) to reach SpO2 target to reach SpO2 target with specific oximeter
次要结局
- Difference between SpO2 and SaO2(assessed up to 10 minutes - at the same of the arterial blood gases punction)
研究者
François Lellouche
Principal investigator
Laval University