Mathematical Arterialization of Venous Blood Gas

NCT03309410 | Completed DMC

• 1 other identifier: vTAC-Pilot
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Matched-Pair Analysis; Blood Gas Analysis; Emergency Service, Hospital

Keywords

Blood Gas Analysis; Emergency Service, Hospital; Venous to arterial conversion; Matched-Pair Analysis

Outcome Measures

Primary Outcomes (12)

• Lin's Concordance correlation coefficient

  Comparison of venous pH between glass and syringe samples.

  1 day

• Lin's Concordance correlation coefficient

  Comparison of venous pCO2 (Unit of Measurement: kilopascal) between glass and syringe samples.

  1 day

• Lin's Concordance correlation coefficient

  Comparison of venous pO2 (Unit of Measurement: kilopascal) between glass and syringe samples.

  1 day

• Bland and Altman plot

  Comparison of venous pH between glass and syringe samples.

  1 day

• Bland and Altman plot

  Comparison of venous pCO2 (Unit of Measurement: kilopascal) between glass and syringe samples.

  1 day

• Bland and Altman plot

  Comparison of venous pO2 (Unit of Measurement: kilopascal) between glass and syringe samples.

  1 day

• Lin's Concordance correlation coefficient

  Comparison of pH between aVBG and ABG.

  1 day

• Lin's Concordance correlation coefficient

  Comparison of pCO2 (Unit of Measurement: kilopascal) between aVBG and ABG.

  1 day

• Lin's Concordance correlation coefficient

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

  1 day

• Bland and Altman plot

  Comparison of pH between aVBG and ABG.

  1 day

• Bland and Altman plot

  Comparison of pCO2 (Unit of Measurement: kilopascal) between aVBG and ABG.

  1 day

• Bland and Altman plot

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

  1 day

Secondary Outcomes (1)

• Hemoglobin concentration

  1 day

Study Arms (2)

Pre-study

In the pre-study, venous samples were collected in paired 2 mL ABG syringes and 4.5 mL tubes from each of the 10 patients, to determine which blood collection method was preferred. VBG samples were collected via a butterfly needle with a three-way stopcock in conjunction with routine venous blood sampling upon admission. VBG samples were collected by the biomedical laboratory technician in the same manner as PVB samples in the normal clinical setting. Results from the pre-study were used to determine the preferred blood collection method in the main study. In this study, paired ABG and VBG samples were collected simultaneously from each of the 20 patients. The ABG samples were collected by the responsible physician. Allocation to either the pre-study or the main study was performed by simple quasi-random allocation in order of admission.

Diagnostic Test: Venous to arterial conversion (v-TAC)

Main study

In this study, paired ABG and VBG samples were collected simultaneously from each of the 20 patients. The ABG samples were collected by the responsible physician. Allocation to either the pre-study or the main study was performed by simple quasi-random allocation in order of admission. The clinical indication for ABG analysis was decided by the responsible physician in the ED upon patient admission and based on national guidelines and criteria.

Diagnostic Test: Venous to arterial conversion (v-TAC)

Interventions

Venous to arterial conversion (v-TAC) DIAGNOSTIC_TEST

This was an observational study. Paired arterial blood gas and venous blood gas was drawn from each patient and compared. Venous blood gas was converted to arterial blood gas values using v-TAC.

Main study; Pre-study

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Circulatory stable patients needing ABG analysis for respiratory and metabolic assessment were selected randomly for participation in the study. Patients were considered circulatory stable if systolic blood pressure was above 90 mmHg and heart rate was 50 to 110 beats/min in accordance with Danish Emergency Process Triage (DEPT), which were used to triage patients upon admission. A total of 30 patients were included; 10 patients for a pre-study purpose and then 20 patients in the following main study.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Aalborg University: lead
• Department of Anesthesiology, North Denmark Regional Hospital: collaborator
• Center for Clinical Research, North Denmark Regional Hospital: collaborator

Related Publications (19)

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Related Links

• Arteriepunktur - Lægehåndbogen (Arterial Blood Gas - Doctor's Handbook)

Biospecimen

Retention: NONE RETAINED

Blood

MeSH Terms

Conditions

Emergencies

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Erika Christensen

  Aalborg University

  STUDY CHAIR

• Peter Leutscher

  Center for Clinical Research, North Denmark Regional Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: October 5, 2017
• First Posted: October 13, 2017
• Study Start: September 1, 2015
• Primary Completion: January 30, 2016
• Study Completion: October 1, 2017
• Last Updated: October 13, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share