Comparison of the Effects of 100% and 80% Oxygen Use During Extubation on Oxygen Reserve Index in Laparoscopic Colorectal Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Oxygen Reserve Index (ORI ) at 60 minutes post-extubation
研究概览
简要总结
During laparoscopic procedures, certain physiological changes occur due to the creation of pneumoperitoneum. One such change is the reduction in portal venous blood flow, which can lead to decreased liver perfusion and acute liver cell injury. Additionally, due to an increased alveolar-arterial oxygen pressure gradient, postoperative atelectasis may occur, leading to hypoxia.
In other words, the increased intra-abdominal pressure during laparoscopic surgery-along with the effects of patient positioning and mechanical ventilation used during anesthesia-can worsen low blood oxygen levels, especially in patients with already reduced lung compliance and higher metabolic demands. This makes close monitoring of oxygenation crucial.
The Oxygen Reserve Index (ORI) is a relatively new tool that can help monitor both high oxygen levels (hyperoxemia) and drops in oxygen (desaturation) before they become clinically apparent. Studies have shown that ORI values range from 0 to 1, with an ORI of 0 typically corresponding to a PaO₂ level between 80-125 mmHg. A downward trend in ORI can act as an early warning sign of hypoxemia, giving clinicians a chance to act before it's too late.
Many studies have highlighted the potential harms of using high oxygen concentrations during surgery. For example, while most hospitals still give patients 100% oxygen before anesthesia (a process called preoxygenation), recent evidence suggests this might increase the risk of atelectasis. Therefore, using 80% or less oxygen is now being recommended in many settings. High oxygen levels have also been linked to increased oxidative stress in the body.
In this study, we aim to investigate whether monitoring ORI during extubation can help us detect and prevent both hyperoxemia and hypoxemia-situations that standard pulse oximetry often misses. We plan to compare two groups of patients: one receiving conventional 100% oxygen during extubation, and another receiving 80% oxygen. By monitoring ORI values in both groups, we hope to better understand how different oxygen levels affect patient safety and outcomes.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18-75
- •ASA: I-III
- •Scheduled for elective laparoscopic surgery
排除标准
- •Patients undergoing emergency surgery due to trauma
- •Patients with ASA physical status classification IV or higher
- •Patients requiring intensive care unit admission
- •Patients with active, clinically symptomatic anemia
- •Patients with heart failure
- •Patients with known allergy to the sensor material to be used
- •Patients with difficult mask ventilation or difficult intubation
- •Patients with a platelet count below 30,000/mm³
- •Patients with a history of gastrointestinal bleeding within the past 6 months
- •Patients with a history of bleeding diathesis or increased risk of intracerebral hemorrhage
- •Patients with oliguria and/or those who required dialysis or underwent dialysis within one month prior to surgery
- •Patients with a known hypersensitivity reaction to any anesthetic or analgesic drug used in the study
- •Patients who do not wish to participate in the study
研究组 & 干预措施
Group 1 - 100% Oxygen Group
Patients in this group will receive 100% oxygen during tracheal extubation in laparoscopic colorectal surgery. Oxygenation will be monitored continuously using the Oxygen Reserve Index (ORI) and arterial PaO₂. The intervention is non-invasive and administered via standard anesthesia breathing systems.
干预措施: Oxygen Administration During Extubation (Behavioral)
Group 2 - 80% Oxygen Group
Patients in this group will receive 80% oxygen during tracheal extubation in laparoscopic colorectal surgery. Oxygenation will be monitored continuously using the Oxygen Reserve Index (ORI) and arterial PaO₂. The intervention is non-invasive and administered via standard anesthesia breathing systems.
干预措施: Oxygen Administration During Extubation (Behavioral)
结局指标
主要结局
Oxygen Reserve Index (ORI ) at 60 minutes post-extubation
时间窗: ORI will be recorded at 60 minutes post-extubation using a Masimo Radical-7 pulse co-oximeter to assess peri-extubation oxygen reserve.
Oxygen Reserve Index (ORI) will be continuously monitored using a Masimo Radical-7 pulse co-oximeter from the time of extubation until 60 minutes post-extubation. The ORI value recorded at the 60th minute after tracheal extubation will be used for primary outcome analysis.
次要结局
- Oxygen Reserve Index (ORI) at 5 minutes post-extubation(5 minutes after tracheal extubation)
- Peripheral Oxygen Saturation (SpO₂, %) trends during and after extubation(Continuous monitoring during and up to 60 minutes after tracheal extubation)
- Arterial oxygen partial pressure (PaO₂, mmHg) at 5 minutes post-extubation(5 minutes after tracheal extubation)
- Arterial oxygen partial pressure (PaO₂, mmHg) at 60 minutes post-extubation(60 minutes after tracheal extubation)
- Heart rate during the first postoperative hour(From extubation until 60 minutes post-extubation)
- Mean arterial pressure (mmHg) during the first postoperative hour(From extubation until 60 minutes post-extubation)
研究者
Türker Kan Taşcı
medical doctor
Dr. Lutfi Kirdar Kartal Training and Research Hospital