两个氧合目标与两个不同血氧计的比较 - 对氧流量和氧合的影响 (Oxygap pong)
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).
研究概览
地位
详细说明
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.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Francois Lellouche
- 电话号码：3572 418656-8711
- 邮箱：francois.lellouche@criucpq.ulaval.ca
研究联系人备份
- 姓名：Pierre Alexandre Bouchard
- 电话号码：2712 418656-8711
- 邮箱：pierre-alexandre.bouchard@criucpq.ulaval.ca
学习地点
-
-
Quebec
-
Québec、Quebec、加拿大、G1V4G5
- 招聘中
- Institut Universitaire de Cardiologie et de Pneumologie de Québec
-
接触：
- Francois Lellouche
- 邮箱：francois.lellouche@criucpq.ulaval.ca
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- ≥ 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
Exclusion Criteria:
- 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
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：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. |
Oxygen titration with FreeO2 device (fixed flow mode) to reach the SpO2 target (set at 90%) with Nonin oximeter |
|
实验性的：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. |
Oxygen titration with FreeO2 device (fixed flow mode) to reach the SpO2 target (set at 90%) with Philips oximeter |
|
实验性的：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. |
Oxygen titration with FreeO2 device (fixed flow mode) to reach the SpO2 target (set at 94%) with Philips oximeter |
|
实验性的：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. |
Oxygen titration with FreeO2 device (fixed flow mode) to reach the SpO2 target (set at 94%) with Philips oximeter |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Oxygen flow (or FiO2)
大体时间：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 |
Mean Oxygen flow in the two last minute of each study period (between minute 8 and 10)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Difference between SpO2 and SaO2
大体时间：assessed up to 10 minutes - at the same of the arterial blood gases punction
|
Difference (%) between SpO2 from each oximeter and SaO2 (% of SaO2 overestimation and underestimation for each oximeter) |
assessed up to 10 minutes - at the same of the arterial blood gases punction
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Mean difference on oxymeter
大体时间：assessed up to 10 minutes - at the same of the arterial blood gases punction
|
Mean (±SD) of the gaps between the different oximeters tested |
assessed up to 10 minutes - at the same of the arterial blood gases punction
|
|
Occult hypoxemia
大体时间：assessed up to 10 minutes - at the same of the arterial blood gases punction
|
Percentage of occult hypoxemia (SaO2<90% and SpO2>=90%) |
assessed up to 10 minutes - at the same of the arterial blood gases punction
|
|
Occult hyperoxemia
大体时间：assessed up to 10 minutes - at the same of the arterial blood gases punction
|
Perrcentage of occult hyperoxemia (SaO2>96% and SpO2<=96%) |
assessed up to 10 minutes - at the same of the arterial blood gases punction
|
|
Partial oxygen weaning
大体时间：Mean oxygen flow in the two last minute of each study period (between minute 8 and 10)
|
Rate of partial oxygen weaning (Oxygen flow <=0.5 L/min) |
Mean oxygen flow in the two last minute of each study period (between minute 8 and 10)
|
|
Complete oxygen weaning
大体时间：Mean oxygen flow in the two last minute of each study period (between minute 8 and 10)
|
Rate of complete oxygen weaning (Oxygen flow =0 L/min or FiO2 0.21) |
Mean oxygen flow in the two last minute of each study period (between minute 8 and 10)
|
|
Respiratory support escalation
大体时间：Mean oxygen flow in the two last minute of each study period (between minute 8 and 10)
|
Indication of initiation of respiratory support escalation (Oxygen flow >6 L/min or FiO2 > 0.60) |
Mean oxygen flow in the two last minute of each study period (between minute 8 and 10)
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.