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临床试验/NCT02237014
NCT02237014已完成不适用

Accuracy of Peripheral Pulse Oximetry Versus Arterial Co-oximeter in Children With Cyanotic Heart Disease

Stanford University1 个研究点 分布在 1 个国家目标入组 53 人开始时间: 2012年11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
53
试验地点
1
主要终点
Accuracy of Peripheral Pulse Oximetry versus Arterial Co-oximeter in Children with Cyanotic Heart Disease

研究概览

简要总结

Peripheral pulse oximetry allows continuous non-invasive measurement of arterial oxygen saturation, but the gold standard for arterial oxygen saturation is co-oximeter which requires an arterial blood sample. The purpose of this research study is to determine the accuracy of a pulse oximeter with a standard sensor (Masimo LNCS sensor) versus with the study sensors, namely Masimo blue sensor and Nellcor Max-I sensors and compared against co-oximetry. Currently available peripheral oximeters (standard) are inaccurate at low oxygen saturation noted in children with cyanotic heart disease. Hence therapeutic interventions (including surgery and cardiac catheterizations) based solely on peripheral oximetry can be delayed and or inadequate. By doing this study the investigators will be able to establish correct limits of peripheral pulse oximeter when using the standard and the study sensors.

详细描述

Peripheral pulse oximetry allows continuous non-invasive measurement of arterial oxygen saturation, but the gold standard for arterial oxygen saturation is co-oximeter which requires an arterial blood sample. The purpose of this research study is to determine the accuracy of a pulse oximeter with a standard sensor (Masimo LNCS sensor) versus with the study sensors, namely Masimo blue sensor and Nellcor Max-I sensors and compared against co-oximetry. Currently available peripheral oximeters (standard) are inaccurate at low oxygen saturation noted in children with cyanotic heart disease. Hence therapeutic interventions (including surgery and cardiac catheterizations) based solely on peripheral oximetry can be delayed and or inadequate. By doing this study we will be able to establish correct limits of peripheral pulse oximeter when using the standard and the study sensors.

The investigator hopes to learn the limits of accuracy of currently available and used pulse oximeters. In children with cyanotic heart disease the "blue sensor" has been found in small studies to be more accurate compared to the "standard" pulse oximeter.

This study is important as it will provide information as to which pulse oximeter should be routinely used in children with cyanotic heart disease and to assess which SPO2 even with blue sensor is borderline and therefore the physician will know to obtain arterial blood sample for co-oximeter prior to planning important procedures based on a saturation reading.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
— 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children from LPCH undergoing cardiac catheterization or heart surgery in SUMC or LPCH respectively
  • Peripheral arterial saturation less than or equal to 90% at time of enrollment
  • weigh between 3-20 kg
  • Less than or equal to 10 years of age

排除标准

  • Lack of consent
  • Greater than 10 years of age
  • Less than 3 kg or more than 20 kg in weight
  • Peripheral arterial saturation greater than 90% at time of enrollment
  • Lack of arterial access

结局指标

主要结局

Accuracy of Peripheral Pulse Oximetry versus Arterial Co-oximeter in Children with Cyanotic Heart Disease

时间窗: 2 year

The primary outcome measure is to describe the bias and precision between the Masimo blue sensor and co-oximetry.

次要结局

  • establish correct limits of peripheral pulse oximeter when using the standard and the study sensors.(2year)

研究者

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

Chandra Ramamoorthy

Professor, Pediatric Cardiac Anesthesia

Stanford University

研究点 (1)

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