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临床试验/NCT07097662
NCT07097662已完成不适用

Evaluation of the Effectiveness of Oxygen Reserve Index Monitoring During Pre-oxygenation in Obese Patients

Irem Caner1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年2月1日最近更新:
适应症

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
Evaluation of the Effectiveness of Oxygen Reserve Index Monitoring During Pre-oxygenation in Obese Patients

研究概览

简要总结

In obese patients, the risk of perioperative complications such as rapid desaturation, atelectasis, difficult mask ventilation, difficult intubation, and hypoxia is higher compared to the normal population. Therefore, preoxygenation is even more critical in the obese patient group. In clinical practice, ETO2 is used as a practical indicator to evaluate sufficient oxygenation during preoxygenation. The Oxygen Reserve Index (ORiⓇ) is a new oxygenation monitoring parameter that is continuously and non-invasively measured by a specialized pulse oximetry device (Masimo, Irvine, CA).The primary objective of the investigators was to observe the correlation between ORIⓇ monitoring and ETO₂ during preoxygenation in obese patients.The secondary objective of the investigators was to evaluate the correlation of ORIⓇ with SpO₂ and PaO₂ in this patient population.

详细描述

Obesity is a chronic, progressive, and recurrent disease characterized by abnormal fat accumulation that adversely affects health and increases morbidity and mortality.

According to World Health Organization (WHO) data, the prevalence of obesity among adults aged 18 years and older is reported to be 16%.

Obese patients have an increased risk of perioperative complications compared to the general population, including rapid desaturation, atelectasis, difficult mask ventilation, difficult intubation, and hypoxia.

Therefore, preoxygenation is particularly important in obese patient populations.

The goal of preoxygenation is to maximize the duration during which the patient can tolerate apnea, thereby providing the anesthesiologist with crucial time to secure the airway in cases of planned or unanticipated "cannot ventilate, cannot intubate" scenarios.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

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

  • Patients with a body mass index (BMI) >35 kg/m² scheduled for elective surgery
  • ASA (American Society of Anesthesiologists) physical status classification I-III
  • Patients aged 18 years and older

排除标准

  • Patients with ASA physical status classification IV-V,
  • Psychiatric disorders
  • Severe cardiac arrhythmias
  • Patients with an ejection fraction below 30%
  • Chronic obstructive pulmonary disease (COPD)
  • Those receiving home oxygen therapy
  • Patients requiring supraglottic airway devices, and emergency cases

结局指标

主要结局

Evaluation of the Effectiveness of Oxygen Reserve Index Monitoring During Pre-oxygenation in Obese Patients

时间窗: During 5-minute preoxygenation

Non-invasive ORiⓇ values and ETO₂ levels measured every minute during tidal volume breathing in the preoxygenation period will be analyzed for correlation.

次要结局

  • Correlation between ORiⓇ and arterial oxygen pressure (PaO₂) at multiple time points after intubation(30, 60, 90, and 120 minutes after intubation)
  • Correlation between ORiⓇ and peripheral oxygen saturation (SpO₂) at multiple time points after intubation(30, 60, 90, and 120 minutes after intubation)

研究者

发起方
Irem Caner
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Irem Caner

Research Assistant

Kocaeli University

研究点 (1)

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