跳至主要内容
临床试验/NCT01861262
NCT01861262已完成不适用

Percentage of Oxygen Saturation of Haemoglobin in Tissues (StO2) Performance Measured on Admission to the Emergency Department in the Assessment of Drug Poisoning

University Hospital, Toulouse2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2013年4月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
300
试验地点
2
主要终点
StO2 performance measured to identify hemodynamic failure.

研究概览

简要总结

The primary purpose of the protocol is to evaluate the StO2 performance measured at the admission to the emergency department to identify hemodynamic failure at the admission or within the first three hours of monitoring patients with drug poisoning.

The study hypotheses are:

  • The early detection of hypoperfusion by StO2, essential to prevent the development of collapse.
  • To limit hemodynamic failure effects, reduce morbidity and mortality of drug poisoning, hospital stay and cost.

详细描述

The procedure is a measurement and non-invasive monitoring system of percentage of oxygen saturation of haemoglobin in tissues using infrared technology. The system used in the study is the tissue oxygenation monitor InSpectraTM StO2 Spot Check, Model 300 consisting of a clamp applied to the base of the thumb of the patient.

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

入选标准

  • admitted to the emergency department,
  • whose pattern of hospitalization is drug poisoning, defined on data from the patient's interrogation or his family if the patient is not able to answer,
  • Written informed consent signed by the patient or, if he's unable to sign, by a companion,
  • Affiliated to medical insurance

排除标准

  • Patients without thenar eminence or having a disease of the thenar,
  • Refusal to participate in the study,
  • Participation in another biomedical research,
  • Patient under guardianship, trusteeship or judicial protection,
  • Pregnant women or nursing mothers

研究组 & 干预措施

Measurement of StO2

Experimental

The procedure is a measurement and non-invasive monitoring system of percentage of oxygen saturation of haemoglobin in tissues using infrared technology. The system used in the study is the tissue oxygenation monitor InSpectraTM StO2 Spot Check, Model 300 consisting of a clamp applied to the base of the thumb of the patient.

干预措施: Measurement of StO2 (Device)

结局指标

主要结局

StO2 performance measured to identify hemodynamic failure.

时间窗: Outcome measure is assessed during three hours after the admission to the emergency department.

次要结局

  • StO2 distribution(Outcome measure is assessed during three hours after the admission to the emergency department.)
  • StO2 threshold value to predict the onset of hemodynamic failure(Outcome measure is assessed during three hours after the admission to the emergency department.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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