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临床试验/NCT07119866
NCT07119866尚未招募不适用

The Role of Oxygen Reserve Index (ORi) Monitoring in Optimizing Apneic Ventilation for Laparoscopic Cholecystectomy

Ankara City Hospital Bilkent1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年8月7日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
试验地点
1
主要终点
TIME FOR ORI TO FALL BELOW 0.24

研究概览

简要总结

Background: The Oxygen Reserve Index (ORI) is a non-invasive parameter utilizing multi-wavelength pulse co-oximetry. ORI can provide early warnings of deteriorating oxygenation before changes are reflected in SpO₂ levels. This study aimed to investigate the feasibility of non-ventilated intubation in patients undergoing cholecystectomy as a means to achieve safe intubation without nasogastric tube placement, with reduced trauma and cost, and improved time efficiency.

详细描述

Obesity is a complex and chronic disease that significantly impacts respiratory physiology. It leads to increased work of breathing and reduced compliance of the chest wall. In morbidly obese individuals, there is a marked reduction in total lung capacity, vital capacity, forced expiratory volume in one second (FEV1), and forced vital capacity (FVC). Additionally, due to their elevated metabolic demands, these patients exhibit higher oxygen consumption rates.

The Oxygen Reserve Index (ORi) (Masimo Corp., Irvine, CA, USA) is an advanced, continuous, and non-invasive parameter that provides a relative indication of arterial partial pressure of oxygen (PaO₂).

ORI monitoring can be particularly beneficial in patients at risk for inadequate preoxygenation, those with difficult mask ventilation, hypoxemic patients with aspiration risk, rapid sequence induction scenarios, obese individuals, ICU intubations, and invasive ventilation cases. It has also been shown to provide early warnings of desaturation in select patient groups, contributing to improved patient safety.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 18-60 years
  • Mallampati score <2
  • Scheduled for elective laparoscopic cholecystectomy under general anesthesia

排除标准

  • <18 and >60 years
  • Initial ORI value below 0.24

结局指标

主要结局

TIME FOR ORI TO FALL BELOW 0.24

时间窗: WITHIN 10 MINUTES BEFORE INTUBATION

TIME THE PATIENT STARTED TO WEAR A MASKS.

次要结局

  • INITIAL ORI VALUE(WITHIN 10 MINUTES BEFORE INTUBATION)
  • ORI VALUE AT 2 MINUTES(WITHIN 10 MINUTES BEFORE INTUBATION)
  • AGE(WITHIN 10 MINUTES BEFORE INTUBATION)
  • American Society of Anesthesiologists (ASA) Score(WITHIN 10 MINUTES BEFORE INTUBATION)
  • SEX(WITHIN 10 MINUTES BEFORE INTUBATION)
  • BMI(WITHIN 10 MINUTES BEFORE INTUBATION)
  • PRESENCE OF A NASOGASTRIC TUBE(10 MINUTES BEFORE EXTUBATION)
  • Surgeon satisfaction(10 MINUTES BEFORE EXTUBATION)
  • PRESENCE OF LARYNGOSPASM(10 MINUTES BEFORE EXTUBATION)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ayça Özcan

Prof.

Ankara City Hospital Bilkent

研究点 (1)

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