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临床试验/NCT01709786
NCT01709786已完成不适用

Non-Invasive Hemoglobin Monitoring in the Patient With Suspected Hemorrhage

University of Cincinnati1 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2012年9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
88
试验地点
1
主要终点
CBC Hemoglobin Measurement Compared to Non-invasive Radical-7 Measurement

研究概览

简要总结

This study will evaluate the accuracy of two rapid methods of measuring hemoglobin in patients with suspected hemorrhage. These methods will be compared with standard laboratory measurements.

详细描述

Anemia and bleeding are major causes of morbidity and mortality in both surgical and nonsurgical patients. The current standard of care for monitoring patients at risk for bleeding is serial measurement of hemoglobin levels. At present, the photometric cyanmethemoglobin method is the most widely used technique for monitoring hemoglobin in the lab, and is currently the gold standard. However, this method has potential for delay before final results are obtained.

Immediate hemoglobin measurements are available with portable point-of-care devices such as the iSTAT, which can produce a measurement of hemoglobin concentration in less than 1 minute. Unfortunately, the accuracy of this device has been reported to vary with hemoglobin level, and as such may not be as accurate in detecting blood loss when compared with the gold standard of laboratory analysis.

Recently, a noninvasive, spectrophotometry-based monitoring technology has been developed. This novel technology measures the differential optical density of wavelengths of light passed through the finger in a method similar to conventional pulse oximetry. While some studies have reported that this device appears to be accurate in patients undergoing elective surgical procedures, more recent work suggests that this accuracy degrades with increased blood loss, lower oximeter signal quality and lower absolute Hgb values.

We will evaluate the accuracy of point-of-care and non-invasive SpHb measurements and utility of continuous hemoglobin monitoring in an intensive care unit setting. If these methods of rapid hemoglobin measurement can be validated in patients at risk for ongoing hemorrhage, use of this technology may result in earlier detection of ongoing hemorrhage, expedite appropriate treatment, and improve patient outcomes.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • admitted to surgical intensive care unit (SICU), and
  • at risk of ongoing bleeding, and
  • requires serial CBC measurements

排除标准

  • < 18 years of age, or
  • a prisoner, or
  • unable to have pulse oximetry readings (due to injuries, burns, amputations, or related problems)

结局指标

主要结局

CBC Hemoglobin Measurement Compared to Non-invasive Radical-7 Measurement

时间窗: n ≥ 1 measurements were taken each day. All measurements (n ≥ 7) from ICU Days 1-7 were used in Bland-Altman analysis, equally weighted.

Whenever blood was drawn for laboratory measurement of serum hemoglobin, we used one drop of blood to make point-of-care measurements using the CDC and Radical-7 methods. For purposes of reporting outcomes measures, we took an equally weighted average of measurements on each device (i.e., all measurement occasions on all patients). These are the means reported in the Outcome Measures Data Table.

CBC Hemoglobin Measurement Compared to Non-invasive iSTAT Measurement

时间窗: n ≥ 1 measurements were taken each day. All measurements (n ≥ 7) from ICU Days 1-7 were used in Bland-Altman analysis, equally weighted.

When blood was drawn for laboratory measurement of serum hemoglobin, one drop of blood was used to make point of care measurements using the CBC and iSTAT methods. For purposes of reporting outcomes measures, we took an equally weighted average of measurements on each device (i.e., all measurement occasions on all patients). These are the means reported in the Outcome Measures Data Table.

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

Betty Tsuei

Professor of Surgery

University of Cincinnati

研究点 (1)

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