跳至主要内容
临床试验/NCT02801162
NCT02801162终止不适用

Evaluation of Accuracy and Precision of the Proxima 3® (Sphere Medical) Arterial Blood Gas Analysis System in Comparison With the Reference Standard Hospital ABG in a Rapidly Changing Clinical Context

Universitair Ziekenhuis Brussel2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2016年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
20
试验地点
2
主要终点
Evaluation of accuracy and precision of the Proxima 3® for ABG

研究概览

简要总结

Evaluate the precision and accuracy of the Proxima 3® System by obtaining quantitative clinical data at various time points. Compare the methods associated with obtaining blood gas results using the Proxima 3® System device versus a conventional ABG analyse. The aim of the investigator is to evaluate the precision and accuracy of the Proxima 3® ABG system parameters (pH, pCO2 pO2, hematocrit and potassium) in clinical practices with rapid changing context.

详细描述

In this study the investigator will test the applicability of the Proxima 3® ABG system in a heterogeneous patient population consisting of patients scheduled for hybrid atrial fibrillation surgery, patients scheduled for heart valve surgery, complex cardiac surgery with deep cooling, spine surgery or patients with expected major blood loss. The investigator will compare the ABG values obtained with the traditional ABG measurement system of the hospital.

The availability of a disposable patient-dedicated blood gas analyser allows rapid, frequent measurement of blood gases in theatre without the loss of theatre staff. As well as facilitating measurement in the unstable patient, this approach opens up the possibility for more frequent measurement to identify patient deterioration before a crisis occurs.

The conventional laboratory ABG method uses sensor technology for pH, pCO2, pO2, sodium, potassium, calcium, glucose and lactate levels. It measures hemoglobin concentration via spectrophotometry methodology at a set wavelength of 467-672 nm. The blood gas laboratory uses ABL90 Flex (Radiometer®). The optical system is based on a 138-wavelength spectrophotometer with a measuring range of 467-672 nm. The spectrophotometer is connected via an optical fiber to a combined hemolyzer and measuring chamber.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
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 and female patients ≥18 years old
  • Patients who have (or will have) an arterial line, which was (will be) inserted for clinical - need, will be considered for inclusion in this study
  • Patients who give informed consent (or their personal/nominated consultee) to participate in the study
  • Patients who are likely to have an arterial line for at least 6 hours.

排除标准

  • Patients contraindicated for an arterial line
  • Refusal of consent by a patient
  • Not for use with patients with uncorrected hyperphosphataemia, hypocalcaemia or hypercalcaemia.
  • The patient is considered to be unsuitable for the study by the investigator

研究组 & 干预措施

Conventional ABG analyser

Active Comparator

干预措施: conventional ABG analyser (Device)

Conventional ABG analyser

Active Comparator

干预措施: Proxima 3® (Device)

Proxima 3® arterial blood gas

Experimental

干预措施: conventional ABG analyser (Device)

Proxima 3® arterial blood gas

Experimental

干预措施: Proxima 3® (Device)

结局指标

主要结局

Evaluation of accuracy and precision of the Proxima 3® for ABG

时间窗: From intubation until extubation, max 1 day

Evaluate the precision and accuracy of the Proxima 3® System by obtaining quantitative clinical data at various time points

次要结局

  • Time to obtain an arterial blood gas(From intubation until extubation, max 1 day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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