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Is Venous to Arterial Conversion (v-TAC) of Blood Gas Reliable in Critical Ill Patients in the ICU?

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03309423
Enrollment
50
Registered
2017-10-13
Start date
2017-10-09
Completion date
2018-03-30
Last updated
2017-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abdomen, Acute, Acidosis, Alkalosis, Metabolic Disease, Respiratory Insufficiency, Sepsis

Keywords

Blood gas analysis, Critical care, venus to arterial conversion

Brief summary

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.

Detailed description

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.

Interventions

Venous to arterial conversion (v-TAC) is a software (Obimedical, Denmark), which can convert venous blood gas values to arterial blood gas values. 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.

Sponsors

Regionshospital Nordjylland
CollaboratorOTHER_GOV
Aalborg University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* Normal pH in arterial blood gas.

Design outcomes

Primary

MeasureTime frameDescription
Lin's Concordance correlation coefficient (CCC)1. january 2018Comparison of pH between ABG and aVBG (from peripheral venous catheter). The closer CCC is to 1 the better correlation.
Bland and Altman's plot1. january 2018Mean difference and 95% limits-of-agreement of pH between ABG and aVBG (from peripheral venous catheter)

Secondary

MeasureTime frameDescription
Number of patient with acute respiratory insufficiency1. january 2018Number and percentage of patients in 'respiratory disease group' group.
Mean number of days until pH neutrality in sepsis group1. january 2018Mean number of days until patients ABG pH was within the range 7.35-7.45 in 'sepsis' group.
Number of patients with sepsis group.1. january 2018Number and percentage of patients in 'sepsis' group.
Mean number of days until pH neutrality in patients with respiratory disease.1. january 2018Mean number of days until patients ABG pH was within the range 7.35-7.45 in 'respiratory disease' group.
Mean number of days until pH neutrality in patients with metabolic disease.1. january 2018Mean number of days until patients ABG pH was within the range 7.35-7.45 in 'metabolic disease' group.
Number of patient with metabolic disease1. january 2018Number and percentage of patients in 'metabolic disease' group.

Countries

Denmark

Contacts

Primary ContactMads Lumholdt
m.lumholdt@rn.dk+45 51914156
Backup ContactKjeld Damgaard
kad@rn.dk+45 51914156

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026