Matched-Pair AnalysisNCT03309410
Mathematical Arterialization of Venous Blood Gas
An observational study of Matched-Pair Analysis and Blood Gas Analysis, run by Aalborg University.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Matched-Pair Analysis, Blood Gas Analysis, Emergency Service, Hospital
- What is being tested?
- Venous to arterial conversion (v-TAC)
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2015to 1 Oct 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Child, Adult, Older adult
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.
Who may be able to join
- Admission to the emergency department.
- Need for ABG for respiratory or metabolic assessment.
Who cannot join
- Circulatory unstable patients (systolic blood pressure < 90mmHg og heart rate <50beats/min or >110beats/min).
About this study
Official title: Is Mathematical Arterialized Peripheral Venous Blood Gas Reliable Compared to Arterial Blood Gas? - a Clinical Validation Study
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.
Read the 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 the serious, though rare, complication 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. A recent systematic review comparing ABG and VBG in the ED setting found similar results and concluded that venous pCO2 was not an accurate representative of arterial pCO2.
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. 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. 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 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).
The aim of this study was to test appropriate practical handling of venous blood gas samples and evaluate the reliability of the v-TAC method, in an acute medical emergency setting in awake and circulatory stable patients capable of giving consent.
Methods Patient inclusion The study was conducted in the ED at North Denmark Regional Hospital from September through October 2015 in daytime. This hospital is 24-hour hospital with a collective medical and abdominal surgery emergency department, with 7-10.000 annual admissions per year.
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. 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.
Blood collection 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.
Blood analysis Blood for VBG analysis collected in the syringe and 4.5 mL tube in the pre-study were analysed within five minutes after sampling. In the main study blood for VBG analysis was collected in three 4.5 mL tubes and converted to arterialised VBG (referred to as aVBG). Each aVBG tube was processed differently as follows: aVBG1 was held steady and analysed within five minutes of sample collection, aVBG2 was tilted in five minutes and analysed after seven minutes and aVBG3 was handled as aVBG1, but analysed after fifteen minutes. ABG samples were analysed within five minutes after sampling. All ABG and VBG samples were analysed with ABL800 blood gas analyser (Radiometer, Denmark) an VBG samples were mathematically converted to aVBG using v-TAC software which was integrated into the ABL800 analyser. In our hospital, the reference values for ABG parameters are as follows: pH 7.37-7.45, pCO2 4.30-6.00 kPa, and pO2 9.60-14.4 kPa. All results from analysed ABG and aVBG samples were registered automatically in the hospital database. On the standard of care basis, only the ABG results were used as the usual standard reference in the medical evaluation of the patients, who took part in the study.
Ethics and data protection The Danish Research Ethics Committee in the North Denmark Region was notified. Since the v-TAC method has previously been approved to be used in clinical research and blood sampling was performed as routine practice, ethical approval was not required. This study was approved by the Danish Data Protection Agency.
- Being tested
- Venous to arterial conversion (v-TAC)
- Keywords
- Blood Gas Analysis, Emergency Service, Hospital, Venous to arterial conversion, Matched-Pair Analysis
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: Venous to arterial conversion (v-TAC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lin's Concordance correlation coefficient
Comparison of venous pH between glass and syringe samples.
Measured: 1 day
Lin's Concordance correlation coefficient
Comparison of venous pCO2 (Unit of Measurement: kilopascal) between glass and syringe samples.
Measured: 1 day
Lin's Concordance correlation coefficient
Comparison of venous pO2 (Unit of Measurement: kilopascal) between glass and syringe samples.
Measured: 1 day
Bland and Altman plot
Comparison of venous pH between glass and syringe samples.
Measured: 1 day
Bland and Altman plot
Comparison of venous pCO2 (Unit of Measurement: kilopascal) between glass and syringe samples.
Measured: 1 day
Bland and Altman plot
Comparison of venous pO2 (Unit of Measurement: kilopascal) between glass and syringe samples.
Measured: 1 day
Lin's Concordance correlation coefficient
Comparison of pH between aVBG and ABG.
Measured: 1 day
Lin's Concordance correlation coefficient
Comparison of pCO2 (Unit of Measurement: kilopascal) between aVBG and ABG.
Measured: 1 day
Lin's Concordance correlation coefficient
Comparison of pO2 (Unit of Measurement: kilopascal) between aVBG and ABG.
Measured: 1 day
Bland and Altman plot
Comparison of pH between aVBG and ABG.
Measured: 1 day
Bland and Altman plot
Comparison of pCO2 (Unit of Measurement: kilopascal) between aVBG and ABG.
Measured: 1 day
Bland and Altman plot
Comparison of pO2 (Unit of Measurement: kilopascal) between aVBG and ABG.
Measured: 1 day
Secondary outcomes (1)
Hemoglobin concentration
Comparison of venous blood hemoglobin (Unit of Measurement: mmol/L) between glass and syringe blood.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2017
- Study start1 Sep 2015
- Primary completion30 Jan 2016
- Study completion1 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Matched-Pair AnalysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Anesthesiology, North Denmark Regional Hospital, Center for Clinical Research, North Denmark Regional Hospital
- Responsible party
- Principal investigator, Mads Lumholdt, Aalborg University
- Investigators
- Erika Christensen, Study chair, Aalborg UniversityPeter Leutscher, Study director, Center for Clinical Research, North Denmark Regional Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03309410
- Sponsor's protocol ID
- vTAC-Pilot
- Status last verified
- Oct 2017
- First submitted
- 5 Oct 2017
- Last updated
- 13 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Sensitive individual participant data (IPD) will not be available to other researchers. IPD will be kept in a secure personal drive within the regions server. All sensitive IPD will be anonymized before publication.
Publications
Dar K, Williams T, Aitken R, Woods KL, Fletcher S. Arterial versus capillary sampling for analysing blood gas pressures. BMJ. 1995 Jan 7;310(6971):24-5. doi: 10.1136/bmj.310.6971.24. No abstract available.
PubMed 7827548Matheson L, Stephenson M, Huber B. Reducing pain associated with arterial punctures for blood gas analysis. Pain Manag Nurs. 2014 Sep;15(3):619-24. doi: 10.1016/j.pmn.2013.06.001. Epub 2014 Feb 24.
PubMed 24572291Leone V, Misuri D, Console N. Radial artery pseudoaneurysm after a single arterial puncture for blood-gas analysis: a case report. Cases J. 2009 Jul 21;2:6890. doi: 10.4076/1757-1626-2-6890.
PubMed 19829877Dev SP, Hillmer MD, Ferri M. Videos in clinical medicine. Arterial puncture for blood gas analysis. N Engl J Med. 2011 Feb 3;364(5):e7. doi: 10.1056/NEJMvcm0803851. No abstract available.
PubMed 21288091Zavorsky GS, Cao J, Mayo NE, Gabbay R, Murias JM. Arterial versus capillary blood gases: a meta-analysis. Respir Physiol Neurobiol. 2007 Mar 15;155(3):268-79. doi: 10.1016/j.resp.2006.07.002. Epub 2006 Aug 17.
PubMed 16919507Ak A, Ogun CO, Bayir A, Kayis SA, Koylu R. Prediction of arterial blood gas values from venous blood gas values in patients with acute exacerbation of chronic obstructive pulmonary disease. Tohoku J Exp Med. 2006 Dec;210(4):285-90. doi: 10.1620/tjem.210.285.
PubMed 17146193McCanny P, Bennett K, Staunton P, McMahon G. Venous vs arterial blood gases in the assessment of patients presenting with an exacerbation of chronic obstructive pulmonary disease. Am J Emerg Med. 2012 Jul;30(6):896-900. doi: 10.1016/j.ajem.2011.06.011. Epub 2011 Sep 9.
PubMed 21908141Kelly AM. Can VBG analysis replace ABG analysis in emergency care? Emerg Med J. 2016 Feb;33(2):152-4. doi: 10.1136/emermed-2014-204326. Epub 2014 Dec 31.
PubMed 25552544Bloom BM, Grundlingh J, Bestwick JP, Harris T. The role of venous blood gas in the emergency department: a systematic review and meta-analysis. Eur J Emerg Med. 2014 Apr;21(2):81-8. doi: 10.1097/MEJ.0b013e32836437cf.
PubMed 23903783Rees SE, Toftegaard M, Andreassen S. A method for calculation of arterial acid-base and blood gas status from measurements in the peripheral venous blood. Comput Methods Programs Biomed. 2006 Jan;81(1):18-25. doi: 10.1016/j.cmpb.2005.10.003. Epub 2005 Nov 21.
PubMed 16303205Tygesen G, Matzen H, Gronkjaer K, Uhrenfeldt L, Andreassen S, Gaardboe O, Rees SE. Mathematical arterialization of venous blood in emergency medicine patients. Eur J Emerg Med. 2012 Dec;19(6):363-72. doi: 10.1097/MEJ.0b013e32834de4c6.
PubMed 22082876Skriver C, Lauritzen MM, Forberg JL, Gaardboe-Poulsen OB, Mogensen CB, Hansen CL, Berlac PA. [Triage quickens the treatment of the most sick patients]. Ugeskr Laeger. 2011 Oct 3;173(40):2490-3. Danish.
PubMed 21975184Toftegaard M, Rees SE, Andreassen S. Evaluation of a method for converting venous values of acid-base and oxygenation status to arterial values. Emerg Med J. 2009 Apr;26(4):268-72. doi: 10.1136/emj.2007.052571.
PubMed 19307387Collins JA, Rudenski A, Gibson J, Howard L, O'Driscoll R. Relating oxygen partial pressure, saturation and content: the haemoglobin-oxygen dissociation curve. Breathe (Sheff). 2015 Sep;11(3):194-201. doi: 10.1183/20734735.001415.
PubMed 26632351Kelly AM, McAlpine R, Kyle E. Venous pH can safely replace arterial pH in the initial evaluation of patients in the emergency department. Emerg Med J. 2001 Sep;18(5):340-2. doi: 10.1136/emj.18.5.340.
PubMed 11559602
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Mathematical Arterialized Peripheral Venous Blood Gas Reliable Compared to Arterial Blood Gas? - a Clinical Validation Study
- ClinicalTrials.gov ID
- NCT03309410
- Acronym / sponsor ID
- vTAC-Pilot
- Keywords
- Blood Gas Analysis, Emergency Service, Hospital, Venous to arterial conversion, Matched-Pair Analysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Aalborg UniversityUniversity, hospital or other
- Collaborators
- Department of Anesthesiology, North Denmark Regional Hospital, Center for Clinical Research, North Denmark Regional Hospital
- Study start
- 1 Sep 2015 (actual)
- Primary completion
- 30 Jan 2016 (actual)
- Study completion
- 1 Oct 2017 (actual)
- First posted
- 13 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 the serious, though rare, complication 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. A recent systematic review comparing ABG and VBG in the ED setting found similar results and concluded that venous pCO2 was not an accurate representative of arterial pCO2.
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. 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. 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 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).
The aim of this study was to test appropriate practical handling of venous blood gas samples and evaluate the reliability of the v-TAC method, in an acute medical emergency setting in awake and circulatory stable patients capable of giving consent.
Methods Patient inclusion The study was conducted in the ED at North Denmark Regional Hospital from September through October 2015 in daytime. This hospital is 24-hour hospital with a collective medical and abdominal surgery emergency department, with 7-10.000 annual admissions per year.
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. 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.
Blood collection 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.
Blood analysis Blood for VBG analysis collected in the syringe and 4.5 mL tube in the pre-study were analysed within five minutes after sampling. In the main study blood for VBG analysis was collected in three 4.5 mL tubes and converted to arterialised VBG (referred to as aVBG). Each aVBG tube was processed differently as follows: aVBG1 was held steady and analysed within five minutes of sample collection, aVBG2 was tilted in five minutes and analysed after seven minutes and aVBG3 was handled as aVBG1, but analysed after fifteen minutes. ABG samples were analysed within five minutes after sampling. All ABG and VBG samples were analysed with ABL800 blood gas analyser (Radiometer, Denmark) an VBG samples were mathematically converted to aVBG using v-TAC software which was integrated into the ABL800 analyser. In our hospital, the reference values for ABG parameters are as follows: pH 7.37-7.45, pCO2 4.30-6.00 kPa, and pO2 9.60-14.4 kPa. All results from analysed ABG and aVBG samples were registered automatically in the hospital database. On the standard of care basis, only the ABG results were used as the usual standard reference in the medical evaluation of the patients, who took part in the study.
Ethics and data protection The Danish Research Ethics Committee in the North Denmark Region was notified. Since the v-TAC method has previously been approved to be used in clinical research and blood sampling was performed as routine practice, ethical approval was not required. This study was approved by the Danish Data Protection Agency.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-study | – | Diagnostic Test: Venous to arterial conversion (v-TAC)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. |
| Main study | – | Diagnostic Test: Venous to arterial conversion (v-TAC)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. |
Who may qualify
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Admission to the emergency department.
- Need for ABG for respiratory or metabolic assessment.
Key exclusion criteria (1 listed)
- Circulatory unstable patients (systolic blood pressure < 90mmHg og heart rate <50beats/min or >110beats/min).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Venous to arterial conversion (v-TAC)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. | Diagnostic test | Main study, Pre-study |
Primary outcome
Lin's Concordance correlation coefficient
Time frame: 1 day
Comparison of venous pH between glass and syringe samples.
Lin's Concordance correlation coefficient
Time frame: 1 day
Comparison of venous pCO2 (Unit of Measurement: kilopascal) between glass and syringe samples.
Lin's Concordance correlation coefficient
Time frame: 1 day
Comparison of venous pO2 (Unit of Measurement: kilopascal) between glass and syringe samples.
Bland and Altman plot
Time frame: 1 day
Comparison of venous pH between glass and syringe samples.
Bland and Altman plot
Time frame: 1 day
Comparison of venous pCO2 (Unit of Measurement: kilopascal) between glass and syringe samples.
Bland and Altman plot
Time frame: 1 day
Comparison of venous pO2 (Unit of Measurement: kilopascal) between glass and syringe samples.
Lin's Concordance correlation coefficient
Time frame: 1 day
Comparison of pH between aVBG and ABG.
Lin's Concordance correlation coefficient
Time frame: 1 day
Comparison of pCO2 (Unit of Measurement: kilopascal) between aVBG and ABG.
Lin's Concordance correlation coefficient
Time frame: 1 day
Comparison of pO2 (Unit of Measurement: kilopascal) between aVBG and ABG.
Bland and Altman plot
Time frame: 1 day
Comparison of pH between aVBG and ABG.
Bland and Altman plot
Time frame: 1 day
Comparison of pCO2 (Unit of Measurement: kilopascal) between aVBG and ABG.
Bland and Altman plot
Time frame: 1 day
Comparison of pO2 (Unit of Measurement: kilopascal) between aVBG and ABG.
1 secondary outcome
Hemoglobin concentration
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2017.
- Background: PubMed 7827548Dar K, Williams T, Aitken R, Woods KL, Fletcher S. Arterial versus capillary sampling for analysing blood gas pressures. BMJ. 1995 Jan 7;310(6971):24-5. doi: 10.1136/bmj.310.6971.24. No abstract available.
- Background: PubMed 24572291Matheson L, Stephenson M, Huber B. Reducing pain associated with arterial punctures for blood gas analysis. Pain Manag Nurs. 2014 Sep;15(3):619-24. doi: 10.1016/j.pmn.2013.06.001. Epub 2014 Feb 24.
- Background: PubMed 19829877Leone V, Misuri D, Console N. Radial artery pseudoaneurysm after a single arterial puncture for blood-gas analysis: a case report. Cases J. 2009 Jul 21;2:6890. doi: 10.4076/1757-1626-2-6890.
- Background: PubMed 21288091Dev SP, Hillmer MD, Ferri M. Videos in clinical medicine. Arterial puncture for blood gas analysis. N Engl J Med. 2011 Feb 3;364(5):e7. doi: 10.1056/NEJMvcm0803851. No abstract available.
- Background: PubMed 16919507Zavorsky GS, Cao J, Mayo NE, Gabbay R, Murias JM. Arterial versus capillary blood gases: a meta-analysis. Respir Physiol Neurobiol. 2007 Mar 15;155(3):268-79. doi: 10.1016/j.resp.2006.07.002. Epub 2006 Aug 17.
- Background: PubMed 17146193Ak A, Ogun CO, Bayir A, Kayis SA, Koylu R. Prediction of arterial blood gas values from venous blood gas values in patients with acute exacerbation of chronic obstructive pulmonary disease. Tohoku J Exp Med. 2006 Dec;210(4):285-90. doi: 10.1620/tjem.210.285.
- Background: PubMed 21908141McCanny P, Bennett K, Staunton P, McMahon G. Venous vs arterial blood gases in the assessment of patients presenting with an exacerbation of chronic obstructive pulmonary disease. Am J Emerg Med. 2012 Jul;30(6):896-900. doi: 10.1016/j.ajem.2011.06.011. Epub 2011 Sep 9.
- Background: PubMed 25552544Kelly AM. Can VBG analysis replace ABG analysis in emergency care? Emerg Med J. 2016 Feb;33(2):152-4. doi: 10.1136/emermed-2014-204326. Epub 2014 Dec 31.
- Background: PubMed 23903783Bloom BM, Grundlingh J, Bestwick JP, Harris T. The role of venous blood gas in the emergency department: a systematic review and meta-analysis. Eur J Emerg Med. 2014 Apr;21(2):81-8. doi: 10.1097/MEJ.0b013e32836437cf.
- Background: PubMed 16303205Rees SE, Toftegaard M, Andreassen S. A method for calculation of arterial acid-base and blood gas status from measurements in the peripheral venous blood. Comput Methods Programs Biomed. 2006 Jan;81(1):18-25. doi: 10.1016/j.cmpb.2005.10.003. Epub 2005 Nov 21.
- Background: PubMed 22082876Tygesen G, Matzen H, Gronkjaer K, Uhrenfeldt L, Andreassen S, Gaardboe O, Rees SE. Mathematical arterialization of venous blood in emergency medicine patients. Eur J Emerg Med. 2012 Dec;19(6):363-72. doi: 10.1097/MEJ.0b013e32834de4c6.
- Background: PubMed 21975184Skriver C, Lauritzen MM, Forberg JL, Gaardboe-Poulsen OB, Mogensen CB, Hansen CL, Berlac PA. [Triage quickens the treatment of the most sick patients]. Ugeskr Laeger. 2011 Oct 3;173(40):2490-3. Danish.
- Arteriepunktur - Lægehåndbogen (Arterial Blood Gas - Doctor's Handbook)Link provided by the sponsor.
- Individual participant dataSharing planned: No. Sensitive individual participant data (IPD) will not be available to other researchers. IPD will be kept in a secure personal drive within the regions server. All sensitive IPD will be anonymized before publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erika Christensen study chair
Aalborg University
Peter Leutscher study director
Center for Clinical Research, North Denmark Regional Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Matched-Pair Analysis and Blood Gas Analysis, run by Aalborg University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lin's Concordance correlation coefficient (time frame: 1 day). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03309410, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2017.