跳至主要内容
临床试验/NCT06983990
NCT06983990已完成不适用

Evaluation of the Relationship of Oxygen Reserve Index (ORI) and End-Tidal Carbon Dioxide (ETCO₂) With Arterial Blood Gas Parameters During the Apnea Test

Bursa Yuksek Ihtisas Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2023年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
35
试验地点
1
主要终点
Correlation between Oxygen Reserve Index (ORI) and arterial PaO2 during apnea test

研究概览

简要总结

This observational study aims to evaluate the relationship between the Oxygen Reserve Index (ORI) and End-Tidal Carbon Dioxide (ETCO2) values with arterial blood gas parameters in patients undergoing the apnea test for the diagnosis of brain death. The study will examine the correlation between ORI and PaO2, as well as between ETCO2 and PaCO2. The primary objective is to assess the effectiveness of ORI in evaluating oxygenation and its applicability in the apnea test. The study will also evaluate the routine use of ORI in monitoring PaO2 and its potential benefits compared to traditional methods.

详细描述

This observational study aims to evaluate the relationship between the Oxygen Reserve Index (ORI) and partial arterial oxygen pressure (PaO2), as well as between End-Tidal Carbon Dioxide (ETCO2) and partial arterial carbon dioxide pressure (PaCO2) in patients undergoing an apnea test for the diagnosis of brain death. ORI is a relatively new, non-invasive monitoring tool that allows continuous and real-time assessment of oxygenation status. It is a dimensionless parameter with values ranging from 0 to 1. ORI is based on a multi-wavelength pulse co-oximeter that detects light absorption in both arterial and venous blood through a probe. It is designed to estimate PaO2 values in the 100-200 mmHg range, as SpO2 typically reaches ≥97% when PaO2 exceeds 80 mmHg, making it unable to reflect higher PaO2 levels accurately. The apnea test is a critical procedure for the diagnosis of brain death, in which the presence or absence of spontaneous breathing in response to carbon dioxide accumulation is evaluated. During the test, arterial blood gas (ABG) measurements are taken to monitor the rise in PaCO2. Before the test begins, the patient is ventilated with 100% oxygen to raise PaO2 above 200 mmHg, which is confirmed with a pre-test ABG sample. The patient must also be normocapnic prior to testing.

As arterial blood sampling is an invasive procedure, this study aims to assess the predictability of PaO2 and PaCO2 using ORI and ETCO2 in the pre-test phase. The primary objective is to determine the capability of ORI to monitor oxygenation status and evaluate its potential to detect hypoxia earlier. Moreover, by comparing ORI to conventional methods, this study seeks to explore its potential routine use in clinical settings for PaO2 monitoring and its possible advantages. In patients undergoing apnea testing for suspected brain death, this study may help determine whether ORI offers benefits over current monitoring approaches and whether it can reduce dependence on invasive ABG sampling. Furthermore, hyperoxia, like hypoxia, poses various clinical risks. The clinical use of ORI alongside SpO2 may help prevent hyperoxia and enable earlier detection of hypoxia. This may enhance patient safety and improve clinical decision-making in critical care environments.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who meet all the prerequisites for initiating the brain death diagnosis process and for whom the decision to perform the apnea test for diagnosis of brain death.
  • Patients aged 18 years or older.
  • Patients who have provided verbal and written consent from their first-degree relatives.

排除标准

  • Patients whose first-degree relatives do not consent to participation in the study.
  • Patients in whom the ORI probe cannot be used due to circulatory disturbances in the extremities

研究组 & 干预措施

Apnea test group

Patients undergoing an apnea test as part of brain death evaluation are monitored for correlation analysis of oxygen reserve index (ORI), end-tidal CO₂ (ETCO₂), and arterial blood gas parameters (PaO₂, PaCO₂). No intervention is applied in this observational study.

干预措施: No intervention (observational monitoring only) (Other)

结局指标

主要结局

Correlation between Oxygen Reserve Index (ORI) and arterial PaO2 during apnea test

时间窗: Before and at specific intervals during the apnea test

Assess the correlation between non-invasive ORI values obtained from Masimo pulse CO-oximeter and arterial partial pressure of oxygen (PaO2) measured from arterial blood gases during the apnea test.

次要结局

  • Correlation between End-Tidal Carbon Dioxide (ETCO2) and arterial PaCO2 during apnea test(Before the apnea test, at the start of the test, and end of the test)

研究者

发起方
Bursa Yuksek Ihtisas Training and Research Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Nilay Sertdemir

Resident Physician in Anesthesiology and Reanimation

Bursa Yuksek Ihtisas Training and Research Hospital

研究点 (1)

Loading locations...

相似试验

ORI and ETCO₂ Relationship With Arterial Blood Gas... | 临床试验