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具有不同氧气接口的几种氧合目标的比较 - 对氧气流速的影响 (Interfaces)

2026年11月3日 更新者:François Lellouche、Laval University

Oxygen therapy is at the heart of the healthcare system. Oxygen flow rates depend on a number of confounding factors confounding factors (target used, skin pigmentation, pulse oximeter used, etc.) The investigators have recently have recently demonstrated that the combination of these factors (different peripheral oxygen saturation (SpO2) targets and different oximeters) can have a significant impact on oxygen flows rates. The effect on oxygen flow was not simply additive .

The aim of this study is to evaluate the impact of the interface used on oxygen flow rates in different patient populations (main objective). The investigatoers also evaluate the impact of the interface on carbon dioxide (PaCO2), in particular with closed oxygen masks, with which rebreathing is theoretically possible (secondary objective).

secondary objective).

研究概览

研究类型

介入性

注册 (估计的)

20

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

    • Quebec
      • Québec、Quebec、加拿大、G1V4G5
        • 招聘中
        • Insitut universitaire de cardiologie et de pneumologie de Quebec - Universite Laval
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Adult (> or = 18 years old)
  • Ongoing on conventional oxygen therapy with peripheral oxygen saturation (SpO2) between 88 and 100% with the usual oximeter
  • SpO2 < 92% ambient air with the usual oximeter

Exclusion Criteria:

  • No SpO2 signal with with the usual oximeter
  • False nails or nail polish
  • Severe anemia documented on last blood count during current hospitalization (haemoglobin (Hb) < 80g/L)
  • Oxygen flow > 6 L/min

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:支持治疗
  • 分配:随机化
  • 介入模型:交叉作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
其他:内尔科血氧计

Oxygen will be administered via nasal cannula up to 6 liters per minute during this period.

Oxygen flow rates will be adjusted manually, with a gradual increase in flow rates to achieve a oxygen flow rates for reach the peripheral oxygen saturation (SpO2) target (92% for non chronic obstructive pulmonary disease (non COPD) patient and 90% for chronic obstructive pulmonary disease (COPD) patient).

The steady state will be defined by a fixed oxygen flow rate and a stable SpO2 around the target ±2% for 15 minutes. The average oxygen flow rate during the last five minutes will be used.

Oxygen will be administered via nasal cannula up to 15 liters per minute during this period.

Oxygen flow rates will be adjusted manually, with a gradual increase in flow rates to achieve a oxygen flow rates for reach the SpO2 target (92% for non COPD patient and 90% for COPD patient).

The steady state will be defined by a fixed oxygen flow rate and a stable SpO2 around the target ±2% for 15 minutes. The average oxygen flow rate during the last five minutes will be used.

Oxygen will be administered via an open during this period. Oxygen flow rates will be adjusted manually, with a gradual increase in flow rates to achieve a oxygen flow rates for reach the SpO2 target (92% for non COPD patient and 90% for COPD patient).

The steady state will be defined by a fixed oxygen flow rate and a stable SpO2 around the target ±2% for 15 minutes. The average oxygen flow rate during the last five minutes will be used.

Oxygen will be administered via simple oxygen face mask during this period. Oxygen flow rates will be adjusted manually, with a gradual increase in flow rates to achieve a oxygen flow rates for reach the SpO2 target (92% for non COPD patient and 90% for COPD patient).

The steady state will be defined by a fixed oxygen flow rate and a stable SpO2 around the target ±2% for 15 minutes. The average oxygen flow rate during the last five minutes will be used.

其他:诺宁血氧计

Oxygen will be administered via nasal cannula up to 6 liters per minute during this period.

Oxygen flow rates will be adjusted manually, with a gradual increase in flow rates to achieve a oxygen flow rates for reach the peripheral oxygen saturation (SpO2) target (92% for non chronic obstructive pulmonary disease (non COPD) patient and 90% for chronic obstructive pulmonary disease (COPD) patient).

The steady state will be defined by a fixed oxygen flow rate and a stable SpO2 around the target ±2% for 15 minutes. The average oxygen flow rate during the last five minutes will be used.

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
大体时间:Mean Oxygen flow in the five last minute of each study period (between minute 10 and 15)

Oxygen flows (or fraction of inspired oxygen (FiO2)) at the end of each study period (last minute average) to reach peripheral oxygen saturation (SpO2) target to reach SpO2 target with specific oxygen administration interfaces

Mean Oxygen flow in the five last minute of each study period (between minute 10 and 15)

次要结果测量

结果测量
措施说明
大体时间
Partial oxygen weaning
大体时间:Mean oxygen flow in the five last minute of each study period (between minute 10 and 15)

Rate of partial oxygen weaning (Oxygen flow <=0.5 L/min)

Mean oxygen flow in the five last minute of each study period (between minute 10 and 15)
Complete oxygen weaning
大体时间:Mean oxygen flow in the five last minute of each study period (between minute 10 and 15)

Rate of complete oxygen weaning (Oxygen flow =0 L/min or FiO2 0.21)

Mean oxygen flow in the five last minute of each study period (between minute 10 and 15)

其他结果措施

结果测量
措施说明
大体时间
Gaps between the different oximeters
大体时间:through period completion, minute 15

Average of the SpO2 value gaps between the different oximeters tested

through period completion, minute 15
Gaps between PaCO2
大体时间:through period completion, minute 15

PaCO2 value at the end of the period

through period completion, minute 15

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2024年11月27日

初级完成 (估计的)

2027年6月1日

研究完成 (估计的)

2027年12月1日

研究注册日期

首次提交

2024年6月17日

首先提交符合 QC 标准的

2024年10月16日

首次发布 (实际的)

2024年10月17日

研究记录更新

最后更新发布 (实际的)

2026年11月5日

上次提交的符合 QC 标准的更新

2026年11月3日

最后验证

2026年11月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 2025-4198

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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