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临床试验/NCT03845192
NCT03845192已完成不适用

Application and Validation of the New Oxygen Reserve Index in Infants < 2 Years Old

Johannes Gutenberg University Mainz2 个研究点 分布在 1 个国家目标入组 107 人开始时间: 2019年2月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
107
试验地点
2
主要终点
time in seconds between ORI-dropping and dropping of SpO2

研究概览

简要总结

In infants less than two years old the new Oxygen Reserve Index (ORI) will be measured during general anaesthesia. It will evaluated if and how ORI-monitoring gives earlier warning of hypoxaemia than conventional oxygen saturation measurement.

详细描述

The Oxygen Reserve Index (ORI) is a new development in multiple wavelength pulse oximetry, reflecting the arterial partial oxygen pressure (PaO2) continuously and non-invasively by an index. In contrast to established standard oxygen saturation (SpO2) measurements, ORI detects a drop of PaO2 until the threshold of 100 mmHg. During anaesthesia induction-associated apnoeic periods ORI may detect a drop of PaO2 early enough for the anaesthesiologist to interrupt the intubation procedure and re-start oxygenation. In contrast, due to the flat upper part of the oxyhaemoglobin dissociation curve, SpO2 stays at values above 90% until PaO2 falls below 60mmHg. At this point, SpO2 drops rapidly and a pro- longed hypoxic dip is the consequence. To avoid this potentially harmful hypoxic dip, continuous monitoring of PaO2 using ORI would be advantageous during anaesthesia induction phase.

This clinical study aims to evaluate the time benefit between alarm of hypoxaemia by the ORI-monitoring and the start of the dropping of oxygen saturation. Pre-set and pre-described ORI-alarms will be checked for their utility and a new ORI-alarm will be defined that is potentially more useful. As secondary endpoints the study examines the correlation of ORI with PO2, the influence of patient or measurement characteristics on the correlation of ORI with PO2 and the influence of the measurement site on ORI-measurement.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
— 至 2 Years(Child)
性别
All
接受健康志愿者

入选标准

  • small infants < 2 years scheduled for elective surgery with general anaesthesia.

排除标准

  • emergency procedures, lack of informed consent of legal guardian

结局指标

主要结局

time in seconds between ORI-dropping and dropping of SpO2

时间窗: during general anaesthesia of the infant

Additionally a potential better definition of ORI-alarm than the preset or previously reported ORI-alarm will be defined

次要结局

  • correlation of ORI and PO2(during general anaesthesia of the infant)
  • influence of patient or measurement characteristics on the correlation of ORI and PO2(during general anaesthesia of the infant)
  • influence of measurement site on the correlation or ORI with PO2 and the influence of the measurement site on ORI measurement(during general anaesthesia of the infant)

研究者

发起方
Johannes Gutenberg University Mainz
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Eva Wittenmeier:MD

principal investigator

Johannes Gutenberg University Mainz

研究点 (2)

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