Effect of Oxygen Reserve Index-Guided Fraction of Inspired Oxygen Titration on the Incidence of Hyperoxemia During One-Lung Ventilation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Incidence of hyperoxemia during one-lung ventilation
研究概览
简要总结
High inspired oxygen concentrations (FiO₂) are commonly administered during general anesthesia to prevent hypoxemia. However, excessive oxygen administration may result in hyperoxemia, which has been associated with impaired hypoxic pulmonary vasoconstriction, increased oxidative stress, ventilation-perfusion mismatch, and postoperative pulmonary complications.
During one-lung ventilation (OLV) for thoracic surgery, higher FiO₂ is often required because of increased intrapulmonary shunting, making hyperoxemia a frequent occurrence. The Oxygen Reserve Index (ORI) is a noninvasive pulse oximetry-derived parameter that reflects moderate hyperoxemia (PaO₂ approximately 100-200 mmHg) and may facilitate more precise oxygen titration than pulse oximetry alone.
详细描述
This prospective, randomized, assessor-blinded clinical trial aims to determine whether FiO₂ titration guided by both ORI and peripheral oxygen saturation (SpO₂) reduces the incidence of hyperoxemia compared with conventional SpO₂-guided FiO₂ titration during OLV in patients undergoing thoracic surgery. Participants will be randomly assigned to either an ORI-guided group or a conventional SpO₂-guided group. The primary outcome is the incidence of hyperoxemia (PaO₂ >125 mmHg) after OLV. Secondary outcomes include SpO₂, ORI, PaO₂, and FiO₂ measured
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged ≥19 years
- •Scheduled for elective lung surgery requiring one-lung ventilation
- •Written informed consent
排除标准
- •Severe pulmonary hypertension.
- •Left ventricular systolic dysfunction.
- •Withdrawal Criteria:
- •The participant or legally authorized representative requests withdrawal from the study.
- •An adverse event occurs that precludes continued participation in the study.
- •The planned surgery or study procedures are not performed (e.g., ORI monitoring is not applied or arterial blood gas analysis is not performed).
- •Perfusion Index is less than 2 during the study.
- •A major violation of the inclusion or exclusion criteria is identified after enrollment.
- •The participant fails to comply with the study protocol, potentially affecting the validity of the study outcomes.
- •Continued participation is considered not to be in the participant's best interest.
- •In the investigator's judgment, any other condition arises that makes continued participation inappropriate.
结局指标
主要结局
Incidence of hyperoxemia during one-lung ventilation
时间窗: 10 min after initiation of one-lung ventilation during operation
Hyperoxemia is defined as an arterial partial pressure of oxygen (PaO₂) greater than 125 mmHg measured after initiation of one-lung ventilation.
次要结局
- Peripheral oxygen saturation (SpO₂)(10 mins after two-lung ventilation, 10 mins after initiation of one-lung ventilation, and 10 mins after resumption of two-lung ventilation, all time frames are included in anesthesia time)
- Oxygen Reserve Index (ORI)(10 mins after two-lung ventilation, 10 mins after initiation of one-lung ventilation, and 10 mins after resumption of two-lung ventilation, all time frames are included in anesthesia time)
- Arterial oxygen tension (PaO₂)(10 mins after two-lung ventilation, 10 mins after initiation of one-lung ventilation, and 10 mins after resumption of two-lung ventilation, all time frames are included in anesthesia time)
- Fraction of inspired oxygen (FiO₂)(10 mins after two-lung ventilation, 10 mins after initiation of one-lung ventilation, and 10 mins after resumption of two-lung ventilation, all time frames are included in anesthesia time)
研究者
Tae-Yop Kim, MD PhD
professor
Konkuk University Medical Center