An observational study in Dyspnea and Hypercapnia, sponsored by University Hospital, Linkoeping. Completed at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-06-16.
Sponsored by University Hospital, Linkoeping · Observational
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.
== 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 ==
The following parameters are documented during sampling:
After sampling, the following is documented:
The documentation will primarily be on worksheets, which will be marked with a patient label (name / social security number) and a serial number. The worksheet will be stored together with consent forms in a locked space of Akutkliniken US Linköping.
The data will be archived in the local emergency department or at the Regional Archives in Östergötland according to applicable laws and regulations.
The result of blood gas analysis is obtained from the digital lab system in the patient record (Lab-ROS) or directly exported from the internal memory of the analyzers at the emergency department. In both cases, the results will be used for digital compilation of study data. All electronic storage of study data will be pseudonymized by linking to patients serial number.
== Statistics ==
In previous studies, the correlation between arterial and venous samples has been evaluated using several different statistical methods:
Our intention in this study is to make a parallel comparison of previously published methods, as well as to examine, based on collected data, whether a new formula with better precision can be derived.
== The potential significance of the project ==
At present, arterial blood gas sampling is used as the standard procedure for assessing a critically ill patient in the emergency department.
The project aims to clarify the feasibility of replacing routine arterial blood gas sampling in the emergency department with venous punctures without impairing test results and patient care. If feasible, such a change in sampling routines could potentially mean a great improvement for patients in terms of pain and complication risks. Also, workflow and lead times in the emergency department could be improved by the fact that venous samples may be drawn by all clinical staff, whereas arterial samples are normally reserved for doctors and nurses with dedicated training.
656 studies on the registry are indexed under Dyspnea; 153 are open to participants now.
This study's enrollment of 250 is above the median of 122 across 204 observational studies indexed under Dyspnea.
Browse Dyspnea studies →University Hospital, Linkoeping is the lead sponsor of 118 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
For enrolment, we will consider all patients who are admitted to the emergency department irrespective of mode of arrival (ambulance, walk-in etc). To be eligible, patients will need to be classified as critical ill and there has to be a clear clinical indication for an arterial blood gas sampling. Indications for arterial blood gas sampling, in turn, are primarily dictated by local SOPs (Standard Operating Procedures; "PM/ vårdprocessåtgärder") for appropriate sampling based on chief complaint, age, and vital signs upon arrival. The aim is to include these patients consecutively around-the-clock.
Exclusion Criteria:
To be eligible, patients will need to be classified as critically ill and there has to be a clear clinical indication for an arterial blood gas sampling. Enrollment will be performed in a consecutive manner at all hours.
Diagnostic Test: Blood gas sampling from artery and vein
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.
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
How does processing times and sampling location affect the result?
Time frame: October - November 2020
How does the patient's vital parameters (blood pressure, pulse) affect the results?
Time frame: October - November 2020
In there a difference in the analysis results between the emergency department and the central laboratory?
Time frame: October - November 2020
How reliable are the results beyond mild to moderate deviations from normal values in consecutive enrolled, critically ill patients?
Time frame: October - November 2020
Plan to share: Undecided
This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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University Hospital, Linkoeping