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临床试验/NCT02707796
NCT02707796Unknown不适用

Evaluation of the Correlation Between Partial Oxygen Pressure and Oxygen Reserve Index, and Sensitivity and Specificity of Oxygen Reserve Index in Patients Undergoing Hemicolectomy

Istanbul University2 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2016年5月最近更新:
适应症

试验速览

阶段
不适用
入组人数
240
试验地点
2
主要终点
Evaluation of the correlation between partial oxygen pressure in arterial blood sample and oxygen reserve index calculated by pulse co-oximetry, and sensitivity and specificity of oxygen reserve index in patients undergoing hemicolectomy

研究概览

简要总结

Oxygen reserve index (ORI) measured by multiple wave pulse co-oximeter is a new technological development in medical science. Our aim in this study is to identify the correlation between arterial oxygen pressure (PaO2) and ORI, and to identify the specificity and sensitivity of ORI as a tool to prevent hypoxia and hyperoxia in abdominal surgery patients.

详细描述

Patients aged between 20-55 years old,American Society of Anesthesiologists physical status 1-2 who will have hemicolectomy will be included to the study. If hemodynamic instability or a sudden decrease in oxygen saturation by pulse oximetry (SpO2) occurs, arterial blood gas analysis will be taken from the patient and ORI, SpO2, PaO2, and arterial oxygen saturation (SaO2) will be recorded. The primer endpoint of the study is to identify the correlation between PaO2 and ORI, seconder end-point is to identify the specificity and sensitivity of ORI as a detector of PaO2. Pearson test for correlation, regression analysis for sensitivity and specificity will be performed. The study will include 240 patients according to power analysis

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Screening
盲法
None

入排标准

年龄范围
20 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged between 20-55 years old
  • American Society of Anesthesiologists physical status I-II
  • Patients undergoing hemicolectomy

排除标准

  • Chronic obstructive and restrictive pulmonary disease
  • Diabetes Mellitus
  • Ischemic heart disease
  • Peripheric artery disease.
  • Operations longer than 200 minutes, requirement transfusion of more than 1 U erythrocyte suspension, and requirement of vasopressor or inotrope infusion will be excluded from the study

结局指标

主要结局

Evaluation of the correlation between partial oxygen pressure in arterial blood sample and oxygen reserve index calculated by pulse co-oximetry, and sensitivity and specificity of oxygen reserve index in patients undergoing hemicolectomy

时间窗: oxygen reserve index and peripheric oxygen saturation will be recorded before and after induction of anesthesia, and every 5 minutes and arterial partial oxygen pressure in every 30 minutes during hemicolectomy.

次要结局

  • Sensitivity and specificity of oxygen reserve index(During Hemicolectomy)

研究者

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

Dr Cigdem Akyol Beyoğlu

MD

Istanbul University

研究点 (2)

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