Sepsis Clinical Trial
Official title:
Utility of Mathematically Converted Venous to Arterial Blood Gas for Clinical Monitoring
Verified date | October 2017 |
Source | Aalborg University |
Contact | Mads Lumholdt |
Phone | +45 51914156 |
m.lumholdt[@]rn.dk | |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | March 30, 2018 |
Est. primary completion date | January 30, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Denmark | Faculty of Medicine, Doctoral School, Ph.d. study | Aalborg | North Denmark |
Lead Sponsor | Collaborator |
---|---|
Aalborg University | North Denmark Regional Hospital |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | Number of patients with sepsis group. | Number and percentage of patients in 'sepsis' group. | 1. january 2018 | |
Secondary | Number of patient with metabolic disease | Number and percentage of patients in 'metabolic disease' group. | 1. january 2018 | |
Secondary | Number of patient with acute respiratory insufficiency | Number and percentage of patients in 'respiratory disease group' group. | 1. january 2018 | |
Secondary | Mean number of days until pH neutrality in sepsis group | Mean number of days until patients ABG pH was within the range 7.35-7.45 in 'sepsis' group. | 1. january 2018 | |
Secondary | Mean number of days until pH neutrality in patients with metabolic disease. | Mean number of days until patients ABG pH was within the range 7.35-7.45 in 'metabolic disease' group. | 1. january 2018 | |
Secondary | Mean number of days until pH neutrality in patients with respiratory disease. | Mean number of days until patients ABG pH was within the range 7.35-7.45 in 'respiratory disease' group. | 1. january 2018 |
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