跳至主要内容
临床试验/NCT02860455
NCT02860455Unknown不适用

Role of Pulse Co-oximetry in Prehospital Emergency Medical Service Management of Suspected Carbon Monoxide Poisoning : A Prospective Multicenter Study.

University Hospital, Montpellier1 个研究点 分布在 1 个国家目标入组 176 人开始时间: 2012年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
176
试验地点
1
主要终点
SpCO optimal threshold value for detection of CO poisoning

研究概览

简要总结

The RAD-57 pulse CO-oximeter is a lightweight device allowing non-invasive measurement of blood carboxyhemoglobin. Previous studies comparing RAD-57 measurements (SpCO) to standard laboratory blood gas analysis (COHb) have reported contradictory results.

the RAD-57 pulse CO-oximeter could be useful as a first-line screening test for acute CO poisoning, enabling rapid detection and management of patients with suspected CO poisoning in the prehospital emergency setting This study assesses the diagnostic value of pulse CO-oximetry, comparing SpCO to standard laboratory blood measurement for prehospital management of patients with suspected carbon monoxide (CO) poisoning.

详细描述

Transcutaneous SpCO will be obtained using the RAD-57 simultaneously with blood sampling for laboratory blood gas analysis, at the time of prehospital management by emergency medical services. The diagnostic performance of SpCO for the screening of CO poisoning will be determined using ROC curve analysis, and Blood COHb levels >5% and 10% as the reference standard for CO poisonning for non-smokers and smokers respectively. Correlation between SpCO and COHb will be assessed using Bland and Altman's method.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patient aged 18 years or older
  • •Patient managed by prehospital emergency medical services.
  • •Patient with a suspected CO exposure presenting or not with clinical signs of CO poisoning

排除标准

  • •Patient for whom venous blood sampling cannot be obtained prehospitally
  • •Patient for whom SpCo measurement cannot be performed prehospitally (cardiac arrest, peripheral vasoconstriction)

研究组 & 干预措施

SpCO and COHb measurement

Other

SpCO measurement (Experimental) : Non invasive pulse CO-oximetry will be carried out in all patients simultaneously with venous blood sampling for standard laboratory blood gas analysis, at time of prehospital management by emergency medical services

COHb measurement (Active comparator) : Blood carboxyhemoglobin testing will be carried out in all patients

干预措施: RAD57 measurement (SpCO) (Device)

SpCO and COHb measurement

Other

SpCO measurement (Experimental) : Non invasive pulse CO-oximetry will be carried out in all patients simultaneously with venous blood sampling for standard laboratory blood gas analysis, at time of prehospital management by emergency medical services

COHb measurement (Active comparator) : Blood carboxyhemoglobin testing will be carried out in all patients

干预措施: CO-oximeter (Device)

结局指标

主要结局

SpCO optimal threshold value for detection of CO poisoning

时间窗: Baseline

prehospital medical management

次要结局

  • COHb Blood carboxyhemoglobin level(Baseline)
  • SpCO level(Baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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