Kartal Dr. Lütfi Kırdar Eğitim ve Araştırma hastanesi
Istanbul, Kartal, 34865, Turkey (Türkiye)
NCT Number: NCT07445698
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.
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Notify Me18 year–75 year
All sexes
Observational
Istanbul, Kartal, 34865, Turkey (Türkiye)
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
This intervention involves the administration of oxygen during tracheal extubation in patients undergoing laparoscopic surgery. Two different oxygen concentrations are compared: the control group receives 100% oxygen, while the study group receives 80% oxygen during the extubation phase. All patients are monitored using the Oxygen Reserve Index (ORI) to assess oxygenation status continuously. The goal is to evaluate the effect of oxygen concentration on peri-extubation hyperoxia and hypoxia, as detected by ORI values. The intervention is non-invasive and administered via standard anesthesia breathing systems.
Time frame: ORI will be recorded at 5 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 5th minute after tracheal extubation will be used for primary outcome analysis.
Time frame: Continuous monitoring during and up to 60 minutes after tracheal extubation
Time frame: 5 minutes after tracheal extubation
Arterial blood gas analysis will be performed to measure PaO₂ and evaluate early postoperative oxygenation status following extubation.
Time frame: 60 minutes after tracheal extubation
ORI will be continuously monitored from extubation until 60 minutes post-extubation using a Masimo Radical-7 device. The ORI value at the 60th minute will be recorded to assess sustained postoperative oxygen reserve.
Time frame: 60 minutes after tracheal extubation
Arterial blood gas analysis will be used to measure PaO₂ at 60 minutes post-extubation to evaluate sustained oxygenation differences between study groups.
Time frame: From extubation until 60 minutes post-extubation
Heart rate will be continuously monitored to evaluate hemodynamic stability during emergence and the early postoperative period.
Time frame: From extubation until 60 minutes post-extubation
Mean arterial pressure will be continuously monitored to assess hemodynamic changes during emergence and the early postoperative period.
Dr. Lutfi Kirdar Kartal Training and Research Hospital
Other Gov
Comparison of the Effects of 100% and 80% Oxygen Use During Extubation on Oxygen Reserve Index in Laparoscopic Colorectal Surgery
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