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临床试验/NCT07168213
NCT07168213招募中不适用

Comparison of Two SpO2 Targets With Two Different Oximeters - Impact on FiO2 During Nasal High Flow Oxygen Therapy

Laval University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年10月21日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
1
主要终点
FiO2

研究概览

简要总结

Several factors can influence oxygenation monitoring and respiratory support through oxygen therapy: the type of oximeter used, skin pigmentation, and the oxygenation target. It is essential to have an accurate measurement of SpO2 in order to optimize the flow of oxygen or FiO2 administered to patients. The question arises as to the impact of these confounding factors on the FiO2 set during high-flow nasal oxygen therapy. The aim of the study is to evaluate the impact of the oxygenation target and the oximeter used on FiO2 in patients receiving high-flow nasal oxygen therapy.

详细描述

The oximeters evaluated will be the Nonin (Plymouth, MN) and the Philips (Eindhoven, Netherlands). Two SpO2 targets will be evaluated: 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.

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
  • •Admiitted in intensive care unit
  • •Presence of an arterial catheter
  • •Ongoing on high flow nasal oxygen therapy with SpO2 between 88 and 100% with a FiO2 between 40 and 80% with the usual oximeter .

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 ...)
  • •Expected to use another respiratory support within two hour of inclusion (NIV or mechanical ventilation)

研究组 & 干预措施

Philips oximeter with a 90% SpO2 target

Experimental

During this periods , oxygen through high flow nasal therapy a will be administered in an manual titration to reach 90% of SpO2.

干预措施: Manual FiO2 titration with Philips oximeter (SpO2 target 90%) (Device)

Nonin oximeter with a 94% SpO2 target

Experimental

During this periods , oxygen through high flow nasal therapy a will be administered in an manual titration to reach 94% of SpO2.

干预措施: Manual FiO2 titration with Nonin oximeter (SpO2 target 94%) (Device)

Philips oximeter with a 94% SpO2 target

Experimental

During this periods , oxygen through high flow nasal therapy a will be administered in an manual titration to reach 94% of SpO2.

干预措施: Manual FiO2 titration with Philips oximeter (SpO2 target 94%) (Device)

Nonin oximeter with a 90% SpO2 target

Experimental

During this periods , oxygen through high flow nasal therapy a will be administered in an manual titration to reach 90% of SpO2.

干预措施: Manual FiO2 titration with Nonin oximeter (SpO2 target 90%) (Device)

结局指标

主要结局

FiO2

时间窗: Mean FiO2 in the two last minute of each study period between minute 8 and 10

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)
  • High flow weaning criteria(Mean FiO2in the two last minute of each study period (between minute 8 and 10))
  • Intensive care unit transfert criteria(Mean FiO2in the two last minute of each study period (between minute 8 and 10))
  • Intubation criteria(Mean FiO2in the two last minute of each study period (between minute 8 and 10))
  • Mean difference on oxymeter(assessed up to 10 minutes - at the same of the arterial blood gases punction)

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 (1)

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