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Clinical Trials/NCT04409470
NCT04409470CompletedNot Applicable

Venous Versus Arterial Blood Gas Sampling in Undifferentiated Emergency Patients

University Hospital, Linkoeping1 site in 1 country250 target enrollmentStarted: October 11, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
250
Locations
1
Primary Endpoint
How does pCO2 correlate between arterial and venous blood gas samples?

Study Overview

Brief Summary

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.

Detailed Description

== 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 ==

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

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

Time Frame: October - November 2020

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

Time Frame: October - November 2020

Secondary Outcomes

  • 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)

Investigators

Sponsor
University Hospital, Linkoeping
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Daniel Wilhelms

PhD, Emergency department head of research

University Hospital, Linkoeping

Study Sites (1)

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