跳至主要内容
临床试验/NCT05505032
NCT05505032已完成4 期

Optimal FiO2 Value, Oxygen Reserve Index, and Prevention of Hyperoxemia in Children: A Prospective, Randomized, Single-blind Study

Baskent University Ankara Hospital1 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2022年8月17日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
108
试验地点
1
主要终点
FiO2 threshold value

研究概览

简要总结

In patients under general anesthesia, the oxygen level (FiO2) used in inspiration is usually adjusted by monitoring the peripheral oxygen saturation level (SpO2). As a non-invasive method, SpO2 monitoring is known as one of the required methods that can be used to adjust FiO2 and detect and treat hypoxemia. While SpO2 approaching 100% matches the value of 128 mmHg in arterial partial oxygen pressure (PaO2), in cases where PaO2 increases more, the investigators cannot follow this situation with SpO2 and cannot prevent hyperoxemia.

As stated in the literature, hyperoxemia has positive effects in general anesthesia and intensive care, as well as negative effects such as increased inflammation, oxidative stress and ischemia-reperfusion. In addition, acute lung injury, development of atelectasis, increased mortality, and critical illness rates have been associated with hyperoxemia in many publications. The only way the investigators can use to measure the level of hyperoxemia seems to be arterial blood gas analysis, and this method limits the investigators use because it is invasive. The Oxygen Reserve Index (ORi™) (Masimo Corp., Irvine, CA, USA) is a variable related to real-time oxygenation reserve status in the mildly hyperoxemic range (approximately 100 - 200 mmHg PaO2). ORi can be defined as a multi-wavelength, noninvasive pulse co-oximetry sensor. ORi is a dimensionless index ranging from 0.00 (no reserve) to 1.00 (maximum reserve) depending on the oxygenation reserve status.

There are very few studies in the literature using ORi to detect hyperoxemia. The investigators thought that if FiO2 levels used in preoxygenation, anesthesia maintenance and recovery stages in day surgeries were correlated with ORi levels, a threshold value could be determined for FiO2 levels during anesthesia stages in cases where invasive arterial blood gas could not be followed.

This study aims to determine the relationship between SpO2, FiO2 and ORi during general anesthesia, to investigate the usefulness of ORi in determining the FiO2 threshold value during anesthesia stages as an indicator of hyperoxemia, and to investigate the effects of these values on the hemodynamics, recovery, agitation and nausea-vomiting states of the patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Investigator)

入排标准

年龄范围
1 Year 至 8 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Patients with an American Society of Anesthesiologists (ASA) score of 1

排除标准

  • Patients with an American Society of Anesthesiologists (ASA) score of 2 and above

研究组 & 干预措施

Group F80

Experimental

In these patients, the FiO2 value will be adjusted to 80% in the perioperative period.

干预措施: Oxygen (Drug)

Group F30

Experimental

In these patients, the FiO2 value will be adjusted to 30% in the perioperative period.

干预措施: Oxygen (Drug)

Group F30

Experimental

In these patients, the FiO2 value will be adjusted to 30% in the perioperative period.

干预措施: Masimo Root Radical 7 (Device)

Group F50

Experimental

In these patients, the FiO2 value will be adjusted to 50% in the perioperative period.

干预措施: Oxygen (Drug)

Group F50

Experimental

In these patients, the FiO2 value will be adjusted to 50% in the perioperative period.

干预措施: Masimo Root Radical 7 (Device)

Group F80

Experimental

In these patients, the FiO2 value will be adjusted to 80% in the perioperative period.

干预措施: Masimo Root Radical 7 (Device)

结局指标

主要结局

FiO2 threshold value

时间窗: Until the surgery is over

Correlation of FiO2 threshold value and ORi value

次要结局

未报告次要终点

研究者

发起方
Baskent University Ankara Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Uslu

Principal Investigator

Baskent University Ankara Hospital

研究点 (1)

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