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临床试验/NCT03309423
NCT03309423Unknown不适用

Utility of Mathematically Converted Venous to Arterial Blood Gas for Clinical Monitoring

Aalborg University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2017年10月9日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
50
试验地点
1
主要终点
Lin's Concordance correlation coefficient (CCC)

研究概览

简要总结

Objective: Arterial blood gas (ABG) is essential in the clinical assessment of potential acutely ill patients venous to arterial conversion (v-TAC), a mathematical method, has recently been developed to convert peripheral venous blood gas (VBG) values to arterialized VBG (aVBG) values. The aim of this study is to test the reliability of aVBG compared to ABG in an intensive care unit (ICU) setting.

Method: Consecutive patients admitted to the ICU with pH values <7,35 or >7,45 are included in this study. Paired ABG and aVBG samples are drawn from patients via arterial catheter, central venous catheter and/or peripheral venous catheter and compared.

详细描述

Arterial blood gas (ABG) analysis is essential in assessment of respiratory and metabolic status in acutely ill patients. In comparison to peripheral venous blood (PVG) sampling, the ABG sampling procedure is more painful for the patient and technically more challenging for the clinician to perform. Other drawbacks of ABG sampling include adverse events such as subcutaneous hematoma, arterial thrombosis or embolization, and pseudoaneurysms.

Peripheral venous blood gas (VBG) sampling has been suggested as an alternative to the ABG procedure. This procedure causes less patient discomfort and the sample can be analysed in combination with other venous blood tests. Studies have revealed that pH and bicarbonate have good correlation, whereas venous and arterial blood gasses (pO2 and pCO2) show low agreement.

However, a new method has been developed to calculate ABG values mathematically from peripheral venous blood by use of venous to arterial conversion (v-TAC) software (Obimedical, Denmark), supplemented with oxygen saturation measured by pulse oximetry. The principle of the method is a mathematical transformation of VBG values to arterialized values (aVBG) by simulating the transport of blood back through the tissue. Initial testing of the method in an emergency department setting showed acceptable clinical congruence between arterial and mathematically arterialized pH and pCO2 with a small difference (+/- SD) on 0.001 +/- 0.024 and 0.00 0.46 kPa, respectively. However, inaccurate values of pO2 were seen when oxygen saturation measured by pulse oximetry was above 96%, due to the flat shape of the oxygen dissociation curve (ODC).

Although most patients in the ICU have arterial catheters therefrom ABG can be drawn, applying arterial catheter is difficult or even impossible in some patients. In relation to step-down some patients get arterial catheters removed and in the event of deterioration in patients acid-base or respiratory disease aVBG could prove useful as a minimally invasive tool to assess patients status.

The aim of this study is to investigate if v-TAC is reliable and safe to use in patients with critically respiratory or metabolic disease admitted to the ICU.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • All patients admitted to the intensive care with the following:
  • Arterial catheter for other purpose.
  • Peripheral venous catheter or central venous catheter for other purpose.

排除标准

  • Normal pH in arterial blood gas.

结局指标

主要结局

Lin's Concordance correlation coefficient (CCC)

时间窗: 1. january 2018

Comparison of pO2 (Unit of Measurement: kilopascal) between ABG and aVBG (from central venous catheter). The closer CCC is to 1 the better correlation.

Bland and Altman's plot

时间窗: 1. january 2018

Mean difference and 95% limits-of-agreement of pO2 (Unit of Measurement: kilopascal) between ABG and aVBG (from central venous catheter).

次要结局

  • Number of patients with sepsis group.(1. january 2018)
  • Number of patient with metabolic disease(1. january 2018)
  • Number of patient with acute respiratory insufficiency(1. january 2018)
  • Mean number of days until pH neutrality in sepsis group(1. january 2018)
  • Mean number of days until pH neutrality in patients with metabolic disease.(1. january 2018)
  • Mean number of days until pH neutrality in patients with respiratory disease.(1. january 2018)

研究者

发起方
Aalborg University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mads Lumholdt

Principal investigator

Aalborg University

研究点 (1)

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