Can Atelectasis be Prevented in Robotic Surgery by Monitoring With Oxygen Reserve Index (ORI)? A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Postoperative LUS score at 30 min
研究概览
简要总结
This single-center randomized controlled trial aims to evaluate whether intraoperative monitoring using the Oxygen Reserve Index (ORI) reduces the incidence of postoperative atelectasis, as assessed by lung ultrasound (LUS), in adult patients undergoing elective robotic surgery under general anesthesia.
详细描述
Postoperative atelectasis is observed in 60-90% of patients undergoing general anesthesia. Factors such as high inspired oxygen concentration, muscle relaxation, and reduced functional residual capacity contribute to its development through mechanisms like absorption atelectasis. The persistence of atelectasis increases the risk of pneumonia, hypoxia, prolonged hospital stay, healthcare costs, and mortality. Despite the well-known pathophysiology, the optimal intraoperative fraction of inspired oxygen (FiO₂) remains unclear.
The Oxygen Reserve Index (ORI) is a non-invasive, continuous parameter that reflects the oxygen reserve within the moderate hyperoxia range (100-200 mmHg). It may facilitate individualized FiO₂ titration to avoid hyperoxia-related atelectasis. Lung ultrasound (LUS) is a reliable, radiation-free bedside tool for detecting atelectasis.
This study hypothesizes that ORI-guided oxygen therapy will reduce the incidence of postoperative atelectasis compared to standard Peripheral Capillary Oxygen Saturation (SpO₂)-guided therapy.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists Physical Status Classification System (ASA) physical status I-III
- •Elective robotic surgery under general anesthesia
- •Surgery duration >2 hours
- •Requires invasive arterial cannulation
- •Signed informed consent
排除标准
- •ASA IV or higher
- •Room air SpO₂ <92%
- •Chronic pulmonary disease
- •Hemoglobinopathy
- •Pregnancy
- •Refusal to participate
研究组 & 干预措施
Peripheral Oxygen Saturation (SpO₂) Group
FiO₂ adjusted based on pulse oximetry to maintain SpO₂ ≥98%
干预措施: Peripheral Oxygen Saturation (SpO₂) Group (Procedure)
Peripheral Oxygen Saturation and Oxygen Reserve Index (SpO₂-ORI) Group
FiO₂ adjusted using both SpO₂ and ORI to maintain ORI between 0-0.3
干预措施: Peripheral Oxygen Saturation and Oxygen Reserve Index (SpO₂-ORI) Group (Procedure)
结局指标
主要结局
Postoperative LUS score at 30 min
时间窗: At 30 minutes following tracheal extubation at the end of surgery
Lung ultrasound (LUS) measurements will be performed by an anesthesiologist blinded to the study groups, who is experienced in lung ultrasonography with at least 100 prior examinations. LUS will be performed and recorded 30 minutes before surgery while patients are in the supine position, using a linear probe (6-12 MHz). The total LUS score will be calculated as the sum of the scores for the 12 quadrants of each hemithorax (range: 0-36). Higher scores will indicate more severe loss of aeration. Loss of aeration will be scored as follows: * 0: Presence of A-lines or fewer than two B-lines * 1: Three or more well-defined B-lines * 2: Presence of multiple coalescent B-lines * 3: Presence of lung consolidation characterized by dynamic air bronchograms
次要结局
- Intraoperative arterial partial pressure of oxygen (PaO₂)(At baseline (immediately before incision), and at 1st, 2nd, and 3rd hour intraoperatively)
- Intraoperative Oxygen Reserve Index (ORI)(At baseline (immediately before incision), and at 1st, 2nd, and 3rd hour intraoperatively)
- Number of episodes with severe hyperoxia (PaO₂ > 200 mmHg)(At baseline (immediately before incision), and at 1st, 2nd, and 3rd hour intraoperatively)
- Preoperative LUS score(30 minutes prior to patient transfer to the operating room)
- Intraoperative fraction of inspired oxygen (FiO₂)(At baseline (immediately before incision), and at 1st, 2nd, and 3rd hour intraoperatively)
研究者
Nilgun Kavrut Ozturk
PROFESSOR MD
Antalya Training and Research Hospital