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临床试验/NCT02382133
NCT02382133已完成不适用

Comparison of Nasal and Forehead Oximetry in Critically Ill Patients at Risk for Decreased Peripheral Perfusion

Washington University School of Medicine2 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2014年10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
43
试验地点
2
主要终点
Accuracy as Indicated by Co-oximetry Measure of Arterial Oxygen Saturation

研究概览

简要总结

Continuous pulse oximetry monitoring is the standard of care in critically ill patients in emergency departments, operating rooms and intensive care units. In patients with poor peripheral perfusion (low blood flow) due to peripheral vascular disease, low body temperature, or shock and the use of medications to raise the blood pressure, clinicians have difficulty obtaining an accurate measurement. This study compares the accuracy of forehead oximetry sensors to nasal alar sensors to lab oximetry measures and on the rate of device related pressure ulcers with both.

详细描述

Continuous pulse oximetry monitoring is the standard of care in critically ill patients in emergency departments, operating rooms and intensive care units. In patients with poor peripheral perfusion (low blood flow) due to peripheral vascular disease, low body temperature, or shock and the use of medications to raise the blood pressure, clinicians have difficulty obtaining an accurate measurement. Several studies have demonstrated the utility of forehead sensor measurements under these clinical conditions. Forehead sensor measurement is considered to be a more central measurement than with digit or ear sensors. However the sensor requires a head band for accurate measurement. On a regular basis, the forehead sensor has led to pressure ulcer development at Barnes-Jewish Hospital despite following vendor recommendations for alternating placement every 8 hours from one side of the forehead to the other. An alternate sensor placed on the nose has recently demonstrated rapid detection of induced drops in oxygen saturation. It has also demonstrated correlation with arterial oxygen saturation measured in a clinical laboratory. The oxygen saturation measurement from the nose is also considered a central measurement. However, studies of the nose sensor were conducted in healthy subjects or during anesthesia care over several hours. Therefore, research is needed to examine the accuracy of the nose sensor in the ICU patient population. In addition, due to concerns for sensor related pressure ulcers in patients with decreased perfusion, the sensor needs to be evaluated for extended periods of time.

研究设计

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

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Presence of an existing arterial catheter for blood sampling and one of the following:
  • Difficulty obtaining a consistent signal from a digit or ear sensor or
  • On pressors of at least 0 .10 mcg/kg/min of norepinephrine or
  • Core temperature < or equal to 35 degrees C

排除标准

  • Anatomic impediments (burns, wounds, dressings, etc.) to placement of the sensor on the forehead or nasal alar
  • History of known dyshemoglobinemias evidenced by carboxyhemoglobin levels > 10% or methemoglobin level > 2%
  • Severe anemia with hemoglobin < 5 g/dL
  • Pregnant women

结局指标

主要结局

Accuracy as Indicated by Co-oximetry Measure of Arterial Oxygen Saturation

时间窗: 24 hours

accuracy of sensor measure was defined as sensor measurements within 3% of co-oximetry measures

次要结局

  • Device Related Pressure Ulcer(5 days)

研究者

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

Lynn Schallom

Research Scientist

Washington University School of Medicine

研究点 (2)

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