Determination of the Incidence of Hyperoxia and the Effectiveness of FiO2 Titration Guided by the Oxygen Reserve Index in Preventing Hyperoxia.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Correlation of FiO2 and ORi value
研究概览
简要总结
Oxygen therapy is the most common treatment modality for patients with hypoxemia, but target values for normoxemia are not clearly defined. Therefore, iatrogenic hyperoxemia is a very common situation. Even though there are many side effects reported related to hyperoxemia and hyperoxemia is shown to be related to worse outcome than expected; clinicians still observe hyperoxemia frequently.
Oxygen reserve index (ORi™) (Masimo Corp., Irvine, USA) can guide clinicians in detection of hyperoxia. ORi is a parameter which can evaluate partial pressure of oxygen (PaO2) rating from 0 to 1. There are growing evidences in ORi that it might be helpful to reduce hyperoxia in general anesthesia. Continuous ORi monitoring can be used for detecting and preventing hyperoxia. The ability to perform FiO2 titration with ORi may be an appropriate monitoring management to prevent the harmful effects of hyperoxia.In this study, in patients who underwent major abdominal surgery; It was aimed to investigate the effectiveness of ORi-guided FiO2 titration in preventing hyperoxia.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients older than 18,
- •Patients scheduled for major abdominal surgery that are expected to last longer than 2 hours
- •Patients that have invasive arterial monitorization
- •American Society of Anesthesiologists physical class I, II or III.
排除标准
- •Patients younger than 18
- •Patients that need to be treated with high doses of vasopressors,
- •Patients having peripheric hypoperfusion,
- •Hemodynamically unstable patients,
- •Patients with hemoglobinopathy,
- •Morbid obesity (bmi>40 kg/m2),
- •Patients with arrythmia that can result in hemodynamic instability, patients with acute coronary syndrome
- •Acute respiratory failure or ARDS.
结局指标
主要结局
Correlation of FiO2 and ORi value
时间窗: Until the surgery is over
Correlation of FiO2 value and ORi value. FiO2 adjusted until ORi reaches to zero and %95\<oxygen saturation≤%98
Correlation of PaO2 and ORİ value
时间窗: Until surgery is over
Pressure of arterial oxygen is obtain from arterial blood gas analysis as usual practice in 10 min and every hour until surgery is over
次要结局
- Heart rate (HR)(First 10 th min after intubation and every hour until surgery is over)
- Diastolic blood pressure (DBP)(First 10 th min after intubation and every hour until surgery is over)
- Positive end-expiratory pressure (PEEP)(First 10 th min after intubation and every hour until surgery is over)
- Systolic blood pressure (SBP)(First 10 th min after intubation and every hour until surgery is over)
- Fraction of inspired oxygen (FiO2)(First 10 th min after intubation and every hour until surgery is over)
研究者
Aykut Saritas
associated professor
Tepecik Training and Research Hospital