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临床试验/NCT03309410
NCT03309410已完成不适用

Is Mathematical Arterialized Peripheral Venous Blood Gas Reliable Compared to Arterial Blood Gas? - a Clinical Validation Study

Aalborg University0 个研究点目标入组 30 人开始时间: 2015年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
主要终点
Lin's Concordance correlation coefficient

研究概览

简要总结

Objective: Arterial blood gas (ABG) analysis 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 was to test the reliability of aVBG compared to ABG in an emergency department (ED) setting.

Method: Twenty ED patients were included in this study. ABG and three aVBG samples were collected from each patient. The aVBG samples were processed in three different ways for comparison: aVBG1 was held steady and analysed within 5 minutes; aVBG2 was tilted in 5 minutes and analysed within 7 minutes; aVBG3 was held steady and analysed after 15 minutes. All VBG samples were arterialized using the v-TAC method. ABG and aVBG samples were compared using Lin's Concordance Correlation Coefficient (CCC) and Bland-Altman's analysis.

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 the serious, though rare, complication 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. A recent systematic review comparing ABG and VBG in the ED setting found similar results and concluded that venous pCO2 was not an accurate representative of arterial pCO2.

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. To facilitate this simulation the following physiologically relevant assumptions were made: 1) The peripheral extremity was well perfused; 2) change in base excess across the tissue sampling site was approximately zero; 3) the respiratory quotient (rate of CO2 production and O2 utilisation over capillaries) could not vary outside the range 0.7 and 1.0, and 4) the haemoglobin concentration was constant from artery to vein. 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 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).

The aim of this study was to test appropriate practical handling of venous blood gas samples and evaluate the reliability of the v-TAC method, in an acute medical emergency setting in awake and circulatory stable patients capable of giving consent.

Methods Patient inclusion The study was conducted in the ED at North Denmark Regional Hospital from September through October 2015 in daytime. This hospital is 24-hour hospital with a collective medical and abdominal surgery emergency department, with 7-10.000 annual admissions per year.

研究设计

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

入排标准

接受健康志愿者

入选标准

  • Admission to the emergency department.
  • Need for ABG for respiratory or metabolic assessment.

排除标准

  • Circulatory unstable patients (systolic blood pressure < 90mmHg og heart rate <50beats/min or >110beats/min).

结局指标

主要结局

Lin's Concordance correlation coefficient

时间窗: 1 day

Comparison of pO2 (Unit of Measurement: kilopascal) between aVBG and ABG.

Bland and Altman plot

时间窗: 1 day

Comparison of pO2 (Unit of Measurement: kilopascal) between aVBG and ABG.

次要结局

  • Hemoglobin concentration(1 day)

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

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