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临床试验/NCT04409470
NCT04409470已完成不适用

Venous Versus Arterial Blood Gas Sampling in Undifferentiated Emergency Patients

University Hospital, Linkoeping1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2021年10月11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
250
试验地点
1
主要终点
How does pCO2 correlate between arterial and venous blood gas samples?

研究概览

简要总结

In the emergency department and intensive care unit, blood gas analysis is a crucial tool in the assessment of critically ill patients. Blood gas analysis is quick and repeatable at the bedside. The sampling can be done from both arterial and venous samples, with arterial samples generally considered to be more reliable and by that widely used as the standard method.

The purpose of this project is to compare venous and arterial blood gas parameters in undifferentiated, critically ill patients. We plan to evaluate the correlation between different parameters through a prospective observational study. In particular, carbon dioxide partial pressure (pCO2) correlation between venous and arterial samples is investigated by using and comparing different conversion models proposed in the literature.

250 patients deemed to be in need of arterial blood gas sampling based on their clinical condition will be included in a consecutive fashion at all hours.

The long-term goal is to clinically translate the findings into a limitation on the use of arterial sampling, which could potentially reduce pain and complication risks in the many patients who undergo arterial blood gas sampling every day.

详细描述

== Practical procedures & flowchart ==

Patients included in this study are treated according to clinical routine. After inclusion, sampling of an arterial blood gas and a venous blood gas is performed simultaneously or as close in time as possible. Because the venous blood gas analysis sample can be taken directly from the patient's peripheral venous catheter, no additional venous puncture is usually required and the additional amount of blood that may be required is approx. 1 ml (the assay requires about 500 µl). In the very rare cases where it is not possible to establish a peripheral venous catheter within a reasonable time, the sample will be acquired from a new venous puncture together with other venous routine samples.

Sampling can be carried out by doctors or nurses. The arterial and venous blood gas analysis is performed with a blood gas analyzer (ABL90) in the emergency department and is performed immediately after the sampling. Sampling times and analysis times are documented.

Survey results are routinely stored in electronic form in patient health record and also locally on the device ABL90 with social security number as ID. The data is saved for statistical analysis.

== Documentation ==

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Patients able to understand and process oral and written information and give his/her consent (within 12h), or consent provided by a close relative.
  • Aged > 18 years
  • Assessed to be in need of arterial blood gas analysis

排除标准

  • Unwilling to participate, or unable to understand the provided information
  • Inability to give subsequently consent (> 12 hours) or unwillingness by close relative to provide consent.
  • Aged < 18 years

结局指标

主要结局

How does pCO2 correlate between arterial and venous blood gas samples?

时间窗: October - November 2020

Can a clinically reliable correlation be identified using a conversion model? (existing or new)

时间窗: October - November 2020

次要结局

  • How reliable are the results beyond mild to moderate deviations from normal values in consecutive enrolled, critically ill patients?(October - November 2020)
  • How does the patient's vital parameters (blood pressure, pulse) affect the results?(October - November 2020)
  • In there a difference in the analysis results between the emergency department and the central laboratory?(October - November 2020)
  • How does processing times and sampling location affect the result?(October - November 2020)

研究者

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

Daniel Wilhelms

PhD, Emergency department head of research

University Hospital, Linkoeping

研究点 (1)

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