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临床试验/NCT07679724
NCT07679724已完成不适用

Evaluation of Oxygen Reserve Index (ORi) in Obese and Non-Obese Patients Over 65 Years Old Scheduled for Elective Surgery Under General Anesthesia

Ankara City Hospital Bilkent1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2023年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
90
试验地点
1
主要终点
Oxygen reserve index (ORi) warning time, SpO2 warning time, and added warning time defined as the difference between the two

研究概览

简要总结

After obtaining ethical committee approval, this single-center, prospective, observational study included volunteer patients of both sexes, aged 65 years and older, with ASA II-III risk scores, who were scheduled for elective surgery with endotracheal intubation under general anesthesia (GAA). 90 patients were divided into two groups: those with normal BMI (19 < BMI < 25 kg/m² (GROUP 1)) and those who were obese (30 < BMI < 40 kg/m² (GROUP 2)). In addition to standard ASA monitoring, a finger sensor (Rainbow® SET, Masimo Inc., Irvine, Ca., USA) was implanted for ORi measurement, and baseline values were recorded. Patients were preoxygenated until EtO2 (endtidal oxygen) concentration reached at least 85%. After ORi reached a plateau level, general anesthesia was induced and endotracheal intubation was performed. After confirming the tube's position, the breathing circuit was disconnected from the endotracheal tube, and patients were allowed to be apneic until SpO2 reached 94%. Throughout this process, patients' other vital signs, SpO₂, and ORi were continuously monitored. The time elapsed when ORi triggered an alarm, when SpO2 reached 97%, and when SpO2 reached 94% was recorded. The 'ORi warning time', 'SpO2 warning time', and the 'additional warning time provided by ORi' (the difference between 'ORi warning time' and 'SpO2 warning time') were recorded.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients of both sexes aged 65 years and older with ASA II-III risk scores who are scheduled to undergo elective surgical procedures with endotracheal intubation under general anesthesia.

排除标准

  • Patients under 65 years of age
  • Patients with heart and lung disease
  • Patients in situations where the patient is unable to cooperate (e.g., dementia, Alzheimer's)
  • Patients suspected of having airway difficulties

结局指标

主要结局

Oxygen reserve index (ORi) warning time, SpO2 warning time, and added warning time defined as the difference between the two

时间窗: 15 minutes after preoxygenation

The primary aim of this study was to determine whether ORi provides an early warning of impending desaturation compared to pulse oximetry in both obese (30 \< BMI \< 40 kg/m²) and normal body mass index (19 \< BMI \< 25 kg/m²) patients over 65 years of age scheduled for elective surgery will be assesed until SpO2 drops to 94%

次要结局

  • Oxygen reserve index (ORi) warning time, SpO2 warning time, and added warning time defined as the difference between the two(15 minutes after preoxygenation)

研究者

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

Çağla TUNCEL

Medical Doctor

Ankara City Hospital Bilkent

研究点 (1)

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