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

NCT03309423 | Unknown DMC

• 1 other identifier: v-TAC-ICU
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Blood gas analysis; Critical care; venus to arterial conversion

Outcome Measures

Primary Outcomes (12)

• Lin's Concordance correlation coefficient (CCC)

  Comparison of pH between ABG and aVBG (from peripheral venous catheter). The closer CCC is to 1 the better correlation.

  1. january 2018

• Lin's Concordance correlation coefficient (CCC)

  Comparison of pCO2 (Unit of Measurement: kilopascal) between ABG and aVBG (from peripheral venous catheter). The closer CCC is to 1 the better correlation.

  1. january 2018

• Lin's Concordance correlation coefficient (CCC)

  Comparison of pO2 (Unit of Measurement: kilopascal) between ABG and aVBG (from peripheral venous catheter). The closer CCC is to 1 the better correlation.

  1. january 2018

• Lin's Concordance correlation coefficient (CCC)

  Comparison of pH between ABG and aVBG (from central venous catheter). The closer CCC is to 1 the better correlation.

  1. january 2018

• Lin's Concordance correlation coefficient (CCC)

  Comparison of pCO2 (Unit of Measurement: kilopascal) between ABG and aVBG (from central venous catheter). The closer CCC is to 1 the better correlation.

  1. january 2018

• Lin's Concordance correlation coefficient (CCC)

  Comparison of pO2 (Unit of Measurement: kilopascal) between ABG and aVBG (from central venous catheter). The closer CCC is to 1 the better correlation.

  1. january 2018

• Bland and Altman's plot

  Mean difference and 95% limits-of-agreement of pH between ABG and aVBG (from peripheral venous catheter)

  1. january 2018

• Bland and Altman's plot

  Mean difference and 95% limits-of-agreement of pCO2 (Unit of Measurement: kilopascal) between ABG and aVBG (from peripheral venous catheter).

  1. january 2018

• Bland and Altman's plot

  Mean difference and 95% limits-of-agreement of pO2 (Unit of Measurement: kilopascal) between ABG and aVBG (from peripheral venous catheter).

  1. january 2018

• Bland and Altman's plot

  Mean difference and 95% limits-of-agreement of pH between ABG and aVBG (from central venous catheter).

  1. january 2018

• Bland and Altman's plot

  Mean difference and 95% limits-of-agreement of pCO2 (Unit of Measurement: kilopascal) between ABG and aVBG (from central venous catheter).

  1. january 2018

• Bland and Altman's plot

  Mean difference and 95% limits-of-agreement of pO2 (Unit of Measurement: kilopascal) between ABG and aVBG (from central venous catheter).

  1. january 2018

Secondary Outcomes (6)

• Number of patients with sepsis group.

  1. january 2018

• Number of patient with metabolic disease

  1. january 2018

• Number of patient with acute respiratory insufficiency

  1. january 2018

• Mean number of days until pH neutrality in sepsis group

  1. january 2018

• Mean number of days until pH neutrality in patients with metabolic disease.

  1. january 2018

Study Arms (3)

Respiratory disease

Patients with acute respiratory insufficiency admitted to the ICU and with pH \<7,35 or \>7,45

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

Metabolic disease

Patients with acute metabolic disease admitted to the ICU and with pH \<7,35 or \>7,45

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

Sepsis

Patients with acute sepsis admitted to the ICU and with pH \<7,35 or \>7,45

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

Interventions

venous to arterial conversion (v-TAC) DIAGNOSTIC_TEST

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.

Metabolic disease; Respiratory disease; Sepsis

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients admitted to the ICU with acid-base and oxygenation parameters outside the normal reference values.

You may qualify if:

• 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.

You may not qualify if:

• Normal pH in arterial blood gas.

Sponsors & Collaborators

• Aalborg University: lead
• Regionshospital Nordjylland: collaborator

Study Sites (1)

Faculty of Medicine, Doctoral School, Ph.d. study

Aalborg, North Denmark, 9000, Denmark

RECRUITING

MeSH Terms

Conditions

Respiratory Insufficiency; Metabolic Diseases; Acidosis; Alkalosis; Sepsis; Abdomen, Acute

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Nutritional and Metabolic Diseases; Acid-Base Imbalance; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Abdominal Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Signs and Symptoms, Digestive

Study Officials

• Peter Leutscher

  Professor, Center for Clinical Research

  STUDY DIRECTOR

Central Study Contacts

Mads Lumholdt

CONTACT

+45 51914156; m.lumholdt@rn.dk

Kjeld Damgaard

CONTACT

+45 51914156; kad@rn.dk

Study Design

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

Study Record Dates

• First Submitted: October 4, 2017
• First Posted: October 13, 2017
• Study Start: October 9, 2017
• Primary Completion: January 30, 2018
• Study Completion: March 30, 2018
• Last Updated: October 13, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)