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临床试验/NCT01284296
NCT01284296已完成不适用

Comparison of Three Methods of Hemoglobin Monitoring in Patients Undergoing Spine or Hip Surgery

University of California, San Francisco1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2010年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
Categorical Groups Based on Magnitude of Differences Between Noninvasive (SpHb) and Laboratory Co-Oximeter (tHb) Hemoglobin in Patients With a Finger Regional Anesthetic Block.

研究概览

简要总结

This study will further investigate the Masimo SpHb [FDA Approved] continuous non-invasive hemoglobin monitor in spine surgery patients. (See NCT00792597) We will investigate the effect of enhanced circulation to the finger (which will be attached to the sensor) following a local injection (digital block) of lidocaine (an FDA approved local anesthetic), and assess the accuracy of the SpHb reading as it relates to a standard laboratory hemoglobin value (tHb).

详细描述

We have completed a study with 20 patients using the latest version of the SpHb monitor software and finger sensor.

The purpose of this study is to assess the accuracy of the SpHb reading as it relates to a standard laboratory hemoglobin value (tHb) following the digital block.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
盲法
None

入排标准

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

入选标准

  • Male or non-pregnant female 18 y/o or older
  • ASA Classification 1, 2 or 3
  • Scheduled to undergo spine or hip revision surgery

排除标准

  • Pregnant or nursing
  • Patients who in the study investigators clinical judgement would not be suitable for research.

研究组 & 干预措施

Digital block

Experimental

干预措施: Lidocaine digital block (Drug)

Digital block

Experimental

干预措施: Masimo SpHb continuous hemoglobin monitor (Device)

结局指标

主要结局

Categorical Groups Based on Magnitude of Differences Between Noninvasive (SpHb) and Laboratory Co-Oximeter (tHb) Hemoglobin in Patients With a Finger Regional Anesthetic Block.

时间窗: A minimum of 2-4 differences recorded approximately hourly during surgery

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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