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临床试验/NCT07538817
NCT07538817尚未招募不适用

EVALUATION OF OXYGEN RESERVE INDEX IN LOW AND NORMAL FLOW ANESTHESIA APPLICATIONS IN LAPAROSCOPIC NEPHRECTOMY CASES IN LATERAL DECUBIT POSITION

Başakşehir Çam & Sakura City Hospital0 个研究点目标入组 48 人开始时间: 2026年4月20日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
48
主要终点
Early detection of hypoxia and hyperoxia in laparoscopic nephrectomy cases with low and normal flow anesthesia using ORI monitoring.

研究概览

简要总结

Oxygen administration is essential in the perioperative period to prevent hypoxia; however, excessive oxygen may cause hyperoxia and related complications. While pulse oximetry is effective in detecting hypoxemia, it is insufficient for identifying hyperoxia when SpO₂ exceeds 97%, often necessitating invasive arterial blood gas analysis. The Oxygen Reserve Index (ORI) is a noninvasive, real-time monitoring parameter reflecting moderate hyperoxic ranges (PaO₂ 100-200 mmHg) and provides early warning of oxygenation changes before SpO₂ alterations occur. Combined use of ORI and pulse oximetry may enable optimal oxygen titration and prevention of both hypoxemia and hyperoxemia.

Laparoscopic nephrectomy is widely performed due to its clinical advantages. In our practice, low and normal fresh gas flow anesthesia are commonly used. Low-flow anesthesia offers benefits such as preservation of heat and humidity, reduced cost, and improved airway physiology. This study aims to determine optimal oxygenation levels during laparoscopic nephrectomy under low and normal fresh gas flow conditions using ORI monitoring.

详细描述

Oxygen is routinely administered to patients in the perioperative setting to prevent the harmful effects of hypoxia. However, high oxygen concentrations may lead to hyperoxia, which can result in significant complications. Therefore, early detection of both hypoxemia and hyperoxemia during the perioperative period is crucial. Pulse oximetry is highly effective in detecting hypoxemia; however, it is insufficient for evaluating oxygenation when SpO₂ exceeds 97%, limiting its usefulness in identifying hyperoxia. In such cases, arterial blood gas analysis, an invasive method, is typically required.

The Oxygen Reserve Index (ORI) is a noninvasive, real-time, and continuous monitoring parameter used to assess oxygenation status. ORI values range from 0 to 1 and reflect arterial partial oxygen pressure levels between approximately 100 and 200 mmHg. Importantly, ORI provides an early warning of deteriorating oxygenation before any detectable changes occur in SpO₂. The combined use of ORI and pulse oximetry may facilitate more precise titration of inspired oxygen concentration and help prevent both hypoxemia and hyperoxemia.

Laparoscopic surgery offers several advantages, including reduced blood loss, improved wound healing, decreased postoperative pain, and shorter hospital stays. Accordingly, laparoscopic techniques are frequently employed for nephrectomy procedures in our clinic.

Depending on clinician preference, low, normal, and high fresh gas flow rates are commonly and safely used in our practice. Low-flow anesthesia provides benefits such as preservation of heat and humidity within the respiratory system, reduced costs, and decreased environmental pollution. Additionally, improved preservation of mucociliary clearance contributes to better maintenance of airway physiology.

In high-risk and major surgeries such as laparoscopic nephrectomy, ORI monitoring is routinely utilized in our clinic to minimize the risks of hypoxemia and hyperoxemia. In this study, we aim to determine optimal oxygenation levels during laparoscopic nephrectomy procedures performed under low and normal fresh gas flow conditions.

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

入选标准

  • Ages 18-75
  • elective surgery laparoscopic nephrectomy

排除标准

  • ASA III,IV,V
  • BMI > 35
  • Those with serious respiratory disease
  • Medications that cause peripheral circulation disorders
  • Patients who started with laparoscopic surgery and then underwent open surgery

研究组 & 干预措施

low-flow anesthesia

0,5 lt/min

normal flow anesthesia

2 lt/min

结局指标

主要结局

Early detection of hypoxia and hyperoxia in laparoscopic nephrectomy cases with low and normal flow anesthesia using ORI monitoring.

时间窗: Perioperative period(approximately 3-6 hours

次要结局

  • The effect of lateral decubitus position on oxygenation in laparoscopic nephrectomies(Perioperative period(approximately 3-6 hours))

研究者

发起方
Başakşehir Çam & Sakura City Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Hilal AKCA

M.D.

Başakşehir Çam & Sakura City Hospital

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