Lung DiseasesNCT04144296
Mathematical Arterialisation of Capillary Blood for Blood Gas Analysis in Critical Ill Patients
A study testing Study procedure in people with Lung Diseases, run by RWTH Aachen University at 1 site in Germany.
Trial summary
The aim of the study is to compare capillary blood gas analysis compensated by v-TAC software (aCBGE, aCBGF) to arterial blood gas analysis (ABG) in terms of pH, pCO2 and pO2 and the clinical usefulness of this method compared to the gold standard of ABG. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Lung Diseases
- What is being tested?
- Study procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteGermany
- Study dates
- 1 Oct 2019to 1 Nov 2021
- Phase
- Interventional
- 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Admission to the intensive / intermediate care or weaning unit at the department of pneumology and intensive care medicine of the university hospital RWTH Aachen
- Arterial line inserted to monitor the patient's blood pressure or respiratory status
- Male or female aged ≥ 18 years
- Written informed consent prior to study participation
- The subject is willing and able to follow the procedures outlined in the protocol
Who cannot join
- Hemodynamic instability
- Impaired perfusion of peripheral limbs e.g. due to severe heart failure
- Pregnant and lactating females. Pregnancy will be ruled out in females of childbearing age by pregnancy test.
- Patient has been committed to an institution by legal or regulatory order
- The subject is mentally or legally incapacitated
Trial locations and contacts
1 site in 1 country.
Ayham Daher, Dr. med. contact
Germany1 site, 1 recruiting
- Recruiting
Clinic for pneumology and internal intensive care
Aachen, 52074
Michael Dreher, Univ.-Prof. Dr. med., mdreher@ukaachen.de
Tobias Müller, PD Dr. med.
About this study
The aim of the study is to compare capillary blood gas analysis compensated by v-TAC software (aCBGE, aCBGF) to arterial blood gas analysis (ABG) in terms of pH, pCO2 and pO2 and the clinical usefulness of this method compared to the gold standard of ABG.
Read the detailed description
In clinical practice blood gas analysis is an essential tool for monitoring respiratory status. The gold-standard method is arterial blood gas analysis (ABG) of blood from the patient's radial or femoral artery. An alternative to arterial sampling commonly used is arterialized capillary blood gas analysis from the earlobe (CBGE). Though CBGE is less invasive and can be performed by non-medical staff, it is less useful in the acute setting because an adequate vasodilatation is needed which typically lasts for at least 10 minutes and the quality of results tends to be operator dependable. Different trials have evaluated the agreement between ABG and CBGE. Whereas a close agreement between ABG and CBGE has been found for evaluating pH and the partial pressure of carbon dioxide (PCO2), several trials showed considerable variations for the partial pressure of oxygen (PO2) and that CBGE tends to underestimate PO2. Similar findings apply for capillary blood gas analysis from the fingertip (CBGF) which is even less accurate compared to CBGE in estimating PO2. Recently a method has been developed to calculate ABG values mathematically from peripheral venous blood, supplemented with oxygen saturation (SpO2) measurement by pulse oximetry, by use of venous-to-arterial conversion (v-TAC) software (OBI Medical, Denmark). The principle of the method is a mathematical transformation of venous blood gas analysis (VBG) values to arterialised values (aVBG) by simulating the transport of blood back through the tissue (6). This approach leads to a clinically acceptable agreement between ABG and aVBG for pH and PCO2. For PO2 the limits of agreement of aVBG are similar to those of PO2 from CBGE for values below 75 mmHg and with mean bias close to zero. However, it has not been evaluated previously whether v-TAC software can be used to calculate ABG values from CBGE (aCBGE) or CBGF (aCBGF). As CBGE and CBGF values are much closer to ABG values, compared to VBG values, the agreement between aCBGE/aCBGF and ABG in terms of pH, PCO2 and pO2 might be better compared to CBG without mathematical arterialisation by v-TAC.
- Conditions
- Lung Diseases
- Being tested
- Study procedure
- Keywords
- Arterial blood gas analysis, Capillary blood gas analysis
- Medical subject headings
- Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study procedureDiagnostic test
- Measurement of the flow rate of supplemental oxygen
- Measurement of the peripheral arterial saturation (SpO2) by pulse oximetry
- Taking of an ABG sample (ABG1) from the arterial line
- Taking of capillary blood gas analysis from the earlobe and from the finger tip
- Taking of an a second ABG (ABG2) from the arterial line
| Study group | Role | What they receive |
|---|---|---|
| Study Arm | Other | All patient will be included in this arm Receives: Diagnostic Test: Study procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of pO2 Levels (in mmHg) in capillary blood samples corrected with VTAC Software to arterial blood samples
Capillary and arterial pO2 Levels will be measured using a blood gas analyser. Afterwards pO2 levels in the capillary sample will be compensated by VTAC software and compensated pO2 levels will be compared to arterial PO2 levels using the Bland-Altman method.
Measured: 10 minutes after the first blood sample is taken
Secondary outcomes (2)
Comparison of pCO2 Levels (in mmHg) in capillary blood samples corrected with VTAC Software to arterial blood samples
Capillary and arterial pCO2 Levels will be measured using a blood gas analyser. Afterwards pCO2 levels in the capillary sample will be compensated by VTAC software and compensated pCO2 levels will be compared to arterial PCO2 levels using the Bland-Altman method.
Measured: 10 minutes after the first blood sample is taken
Comparison of pH in capillary blood samples corrected with VTAC Software to arterial blood samples
Capillary and arterial pH will be measured using a blood gas analyser. Afterwards pH in the capillary sample will be compensated by VTAC software and compensated pH will be compared to arterial pH levels using the Bland-Altman method.
Measured: 10 minutes after the first blood sample is taken
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2019
- Study start1 Oct 2019
- Primary completion1 Oct 2021 (estimated)
- Study completion1 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung DiseasesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Collaborators
- OBI Medical
- Responsible party
- Principal investigator, PD Dr. Tobias Müller, RWTH Aachen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04144296
- Sponsor's protocol ID
- 18-125
- Status last verified
- Sep 2021
- First submitted
- 21 Oct 2019
- Last updated
- 21 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mathematical Arterialisation of Capillary Blood for Blood Gas Analysis in Critical Ill Patients
- ClinicalTrials.gov ID
- NCT04144296
- Acronym / sponsor ID
- 18-125
- Conditions
- Lung Diseases
- Keywords
- Arterial blood gas analysis, Capillary blood gas analysis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Collaborators
- OBI Medical
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 1 Oct 2021 (estimated)
- Study completion
- 1 Nov 2021 (estimated)
- First posted
- 30 Oct 2019 (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.
The aim of the study is to compare capillary blood gas analysis compensated by v-TAC software (aCBGE, aCBGF) to arterial blood gas analysis (ABG) in terms of pH, pCO2 and pO2 and the clinical usefulness of this method compared to the gold standard of ABG.
Detailed description
In clinical practice blood gas analysis is an essential tool for monitoring respiratory status. The gold-standard method is arterial blood gas analysis (ABG) of blood from the patient's radial or femoral artery. An alternative to arterial sampling commonly used is arterialized capillary blood gas analysis from the earlobe (CBGE). Though CBGE is less invasive and can be performed by non-medical staff, it is less useful in the acute setting because an adequate vasodilatation is needed which typically lasts for at least 10 minutes and the quality of results tends to be operator dependable. Different trials have evaluated the agreement between ABG and CBGE. Whereas a close agreement between ABG and CBGE has been found for evaluating pH and the partial pressure of carbon dioxide (PCO2), several trials showed considerable variations for the partial pressure of oxygen (PO2) and that CBGE tends to underestimate PO2. Similar findings apply for capillary blood gas analysis from the fingertip (CBGF) which is even less accurate compared to CBGE in estimating PO2. Recently a method has been developed to calculate ABG values mathematically from peripheral venous blood, supplemented with oxygen saturation (SpO2) measurement by pulse oximetry, by use of venous-to-arterial conversion (v-TAC) software (OBI Medical, Denmark). The principle of the method is a mathematical transformation of venous blood gas analysis (VBG) values to arterialised values (aVBG) by simulating the transport of blood back through the tissue (6). This approach leads to a clinically acceptable agreement between ABG and aVBG for pH and PCO2. For PO2 the limits of agreement of aVBG are similar to those of PO2 from CBGE for values below 75 mmHg and with mean bias close to zero. However, it has not been evaluated previously whether v-TAC software can be used to calculate ABG values from CBGE (aCBGE) or CBGF (aCBGF). As CBGE and CBGF values are much closer to ABG values, compared to VBG values, the agreement between aCBGE/aCBGF and ABG in terms of pH, PCO2 and pO2 might be better compared to CBG without mathematical arterialisation by v-TAC.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Arm | Other | Diagnostic Test: Study procedureAll patient will be included in this arm |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Admission to the intensive / intermediate care or weaning unit at the department of pneumology and intensive care medicine of the university hospital RWTH Aachen
- Arterial line inserted to monitor the patient's blood pressure or respiratory status
- Male or female aged ≥ 18 years
- Written informed consent prior to study participation
- The subject is willing and able to follow the procedures outlined in the protocol
Key exclusion criteria (5 listed)
- Hemodynamic instability
- Impaired perfusion of peripheral limbs e.g. due to severe heart failure
- Pregnant and lactating females. Pregnancy will be ruled out in females of childbearing age by pregnancy test.
- Patient has been committed to an institution by legal or regulatory order
- The subject is mentally or legally incapacitated
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 |
|---|---|---|
| Study procedure* Measurement of the flow rate of supplemental oxygen * Measurement of the peripheral arterial saturation (SpO2) by pulse oximetry * Taking of an ABG sample (ABG1) from the arterial line * Taking of capillary blood gas analysis from the earlobe and from the finger tip * Taking of an a second ABG (ABG2) from the arterial line | Diagnostic test | Study Arm |
Primary outcome
Comparison of pO2 Levels (in mmHg) in capillary blood samples corrected with VTAC Software to arterial blood samples
Time frame: 10 minutes after the first blood sample is taken
Capillary and arterial pO2 Levels will be measured using a blood gas analyser. Afterwards pO2 levels in the capillary sample will be compensated by VTAC software and compensated pO2 levels will be compared to arterial PO2 levels using the Bland-Altman method.
2 secondary outcomes
Comparison of pCO2 Levels (in mmHg) in capillary blood samples corrected with VTAC Software to arterial blood samples
Time frame: 10 minutes after the first blood sample is taken
Comparison of pH in capillary blood samples corrected with VTAC Software to arterial blood samples
Time frame: 10 minutes after the first blood sample is taken
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2021.
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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.
Ayham Daher, Dr. med. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Study procedure in people with Lung Diseases, run by RWTH Aachen University at 1 site in Germany.
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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 21 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tobias Müller, PD Dr. med. (+492418036470, tobmueller@ukaachen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of pO2 Levels (in mmHg) in capillary blood samples corrected with VTAC Software to arterial blood samples (time frame: 10 minutes after the first blood sample is taken). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Sep 2021.