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临床试验/NCT01114932
NCT01114932已完成不适用

The Optimum Time for Preoxygenation Based on Body Mass Index

Cedars-Sinai Medical Center1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2007年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
75
试验地点
1
主要终点
Time to reach 90% end tidal oxygen saturation using monitor and stop watch

研究概览

简要总结

The purpose of this study is to evaluate the relationship between the time needed to raise the oxygen concentration in patient's blood to 90% and his/or her body mass index. The prevalence of obesity in our society continues to rise. No studies have shown the time required for preoxygenation (oxygen given) in relation to body mass index (body weight in kg/height in meter2).

详细描述

100% oxygen given to patient before induction of anesthesia (asleep) is the standard clinical care. However, studies using various methods have shown differences in terms of the optimal time, technique and number of breaths needed for efficient oxygenation. The only difference to the standard pre-anesthesia care is that we will record the time to raise patient oxygen to 90%. Age is recorded to ensure that the subjects fall within our inclusion criteria. The weight (W) in kilograms and height (H) in meters will be used to calculate the body mass index (BMI): BMI = W/H2. Alveolar oxygen uptake is dependent on respiratory rate, heart rate, blood pressure, temperature and hemoglobin level. These parameters are measured in order to identify factors that may affect the accuracy of the study. We will record the pulse oximetry value to note the initial oxygen saturation on room air and after the oxygenation.

Facial hair and mask fit are recorded to assess possible failure of an optimal facemask seal. End-tidal carbon dioxide (FE'CO2) is also measured to ensure an adequate facemask seal. Anxiety can increase the respiratory rate, heart rate and affect patient compliance with a fitted facemask. All of the aforementioned values are recorded to assess reasons for possible failure of the preoxygenation technique and inaccurate results.

研究设计

研究类型
Observational
时间视角
Prospective

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Participants between the ages of 18-50 years with no limitations as to gender or race
  • Participants classified as ASA 1 or 2
  • Participants capable of understanding and signing an informed consent

排除标准

  • Conditions which would affect their oxygenation such as heart disease, lung disease, anemia (Hemoglobin less than 12 g/dL)
  • History of smoking (smoking can affect pulmonary function and oxygen carrying capacity)
  • Acute substance abuse (substance abuse can affect respiratory function).
  • Maxillofacial abnormalities which would interfere with proper face mask seal.

结局指标

主要结局

Time to reach 90% end tidal oxygen saturation using monitor and stop watch

时间窗: 1 to 10 minutes

Using monitors on the anesthesia machine, we recorded the end tidal oxygen saturation value and also recorded the time at which the end tidal oxygen was recorded. From the information collected the relationship between BMI and gender with the time to 90% end tidal oxygen saturation will be evaluated.

次要结局

未报告次要终点

研究者

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

Roya Yumul, M.D.,PhD.

Residency program director, Department of anesthesiology

Cedars-Sinai Medical Center

研究点 (1)

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