Pulmonary Disease (COPD), Chronic ObstructiveGAZOCAPNCT07835945
Comparison of Arterial and Capillary Blood Gas Analyses in Patients With Respiratory Distress Due to COPD or APE
A study testing Capillary blood gas analysis in people with Pulmonary Disease (COPD), Chronic Obstructive, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
The assessment of gas exchange is crucial for the management of patients suffering from respiratory distress due to an exacerbation of chronic obstructive pulmonary disease (COPD) or cardiogenic acute pulmonary edema (APE). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Disease (COPD), Chronic Obstructive
- What is being tested?
- Capillary blood gas analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteFrance
- Study dates
- 28 Sep 2026to 24 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients older than 18 years old
- Patients admitted in the emergency care unit with an exacerbation of COPD or a cardiogenic APE requiring a non-invasive ventilation (i.e. for COPD patients pH< 7.35, for APE patients: PCO2 > 45 mmHg)
- Patients affiliated to a social security system
Who cannot join
- Patients for which a non-invasive ventilation was initiated upon pre-hospital care
- Contraindication for non-invasive ventilation
- Patients for which non-invasive ventilation is not indicated
- Patients for which capillary or arterial blood gas analyses are impossible
- Adults subject to legal guardianship (guardianship, conservatorship)
- Pregnant women
- Patients with a congenital heart disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de Nice
Nice, 06000
Nathalie Ducot, MD-PhD, +33 (0)4 92 03 32 42, ducot.n@chu-nice.fr
About this study
The assessment of gas exchange is crucial for the management of patients suffering from respiratory distress due to an exacerbation of chronic obstructive pulmonary disease (COPD) or cardiogenic acute pulmonary edema (APE). These measurements are used by physicians to determine the need for noninvasive ventilation (NIV) as well as to evaluate its effectiveness and to decide whether to continue the treatment.
Arterial blood gas analysis is currently the gold standard for the measurement of these gas exchanges, though invasive, painful and risky (failure risks and possible local complications). Capillary blood gas analysis, which consists in collecting a blood drop from the ear or the finger by capillarity after punction, could represent a less invasive alternative. However, data comparing the performances of arterial and capillary blood gas analysis in the context of respiratory distress requiring a NIV remain limited.
This study is based on the hypothesis that capillary blood gas analysis can perform as well as arterial blood gas analysis. It is aimed at comparing values obtained from arterial and capillary blood gas analyses from patients with respiratory distress and requiring a NIV due to an exacerbation of COPD or cardiogenic APE.
- Being tested
- Capillary blood gas analysis
- Keywords
- capillary blood gas analyses, arterial blood gas analyses, respiratory distress, COPD, APE
- Medical subject headings
- Lung Diseases, Pulmonary Disease, Chronic Obstructive, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capillary blood gas analysisDiagnostic test
The intervention consists in carrying out arterial, veinous and capillary blood gas analyses before submitting the patient to noninvasive ventilation (5 minutes will separate each sampling). Data from these samplings will be recorded. 1 hour after the implementation of the noninvasive ventilation, patients will once again undergo arterial, veinous and capillary samplings for blood gas analyses. Respiratory parameters will be recorded as well at the onset of the noninvasive ventilation and one hour after its start.
| Study group | Role | What they receive |
|---|---|---|
| Respiratory distress arm requiring a noninvasive ventilation | Experimental | Not described Receives: Diagnostic Test: Capillary blood gas analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement between carbon dioxide pressure (PCO2) values obtained from capillary and arterial blood gas analyses in patients requiring a non-invasive ventilation due to an exacerbation of COPD or a cardiogenic APE.
Agreement between arterial and capillary pCO₂ measurements, assessed using Bland-Altman analysis with mean bias and the 95% limits of agreement
Measured: Baseline (once the patient arrives at the emergency care unit and is included in the study)
Secondary outcomes (15)
Agreement between pH values obtained from capillary and arterial blood gas analyses in patients requiring a non-invasive ventilation due to an exacerbation of COPD or a cardiogenic APE
Agreement between pH values obtained from capillary and arterial blood gas analyses, assessed using Bland-Altman analysis with mean bias and the 95% limits of agreement.
Measured: Baseline (once the patient arrives at the emergency care unit and is included in the study)
Agreement between bicarbonate concentration values obtained from capillary and arterial blood gas analyses in patients requiring a non-invasive ventilation due to an exacerbation of COPD or a cardiogenic APE.
Agreement between bicarbonate concentration values obtained from capillary and arterial blood gas analyses, assessed using Bland-Altman analysis with mean bias and the 95% limits of agreement.
Measured: Baseline (once the patient arrives at the emergency care unit and is included in the study)
Agreement between base concentration values obtained from capillary and arterial blood gas analyses in patients requiring a non-invasive ventilation due to an exacerbation of COPD or a cardiogenic APE.
Agreement between base concentration values obtained from capillary and arterial blood gas analyses, assessed using Bland-Altman analysis with mean bias and the 95% limits of agreement
Measured: Baseline (once the patient arrives at the emergency care unit and is included in the study)
Agreement between PCO2 values obtained from capillary and arterial blood gas analyses in patients with an exacerbation of COPD or a cardiogenic APE one hour after initiation of non-invasive ventilation.
Agreement between PCO2 values obtained from capillary and arterial blood gas analyses, assessed using Bland-Altman analysis with mean bias and the 95% limits of agreement
Measured: One hour after initiation of non-invasive ventilation.
Agreement between pH values obtained from capillary and arterial blood gas analyses in patients with an exacerbation of COPD or a cardiogenic APE one hour after initiation of non-invasive ventilation.
Agreement between pH values obtained from capillary and arterial blood gas analyses, assessed using Bland-Altman analysis with mean bias and the 95% limits of agreement.
Measured: One hour after initiation of non-invasive ventilation.
Agreement between bicarbonate concentration values obtained from capillary and arterial blood gas analyses in patients with an exacerbation of COPD or a cardiogenic APE one hour after initiation of non-invasive ventilation.
Agreement between bicarbonate concentration values obtained from capillary and arterial blood gas analyses, assessed using Bland-Altman analysis with mean bias and the 95% limits of agreement
Measured: One hour after initiation of non-invasive ventilation.
Agreement between base concentration values obtained from capillary and arterial blood gas analyses in patients with an exacerbation of COPD or a cardiogenic APE one hour after initiation of non-invasive ventilation.
Agreement between base concentration values obtained from capillary and arterial blood gas analyses, assessed using Bland-Altman analysis with mean bias and the 95% limits of agreement.
Measured: One hour after initiation of non-invasive ventilation.
Agreement between PCO2 values obtained from veinous and arterial blood gas analyses in patients requiring a non-invasive ventilation due to an exacerbation of COPD or a cardiogenic APE.
Agreement between PCO2 values obtained from veinous and arterial blood gas analyses, assessed using Bland-Altman analysis with mean bias and the 95% limits of agreement
Measured: Baseline (once the patient arrives at the emergency care unit and is included in the study).
Agreement between pH values obtained from veinous and arterial blood gas analyses in patients requiring a non-invasive ventilation due to an exacerbation of COPD or a cardiogenic APE.
Agreement between pH values obtained from veinous and arterial blood gas analyses, assessed using Bland-Altman analysis with mean bias and the 95% limits of agreement.
Measured: Baseline (once the patient arrives at the emergency care unit and is included in the study).
Agreement between bicarbonate concentration values obtained from veinous and arterial blood gas analyses in patients requiring a non-invasive ventilation due to an exacerbation of COPD or a cardiogenic APE.
Agreement between bicarbonate concentration values obtained from veinous and arterial blood gas analyses, assessed using Bland-Altman analysis with mean bias and the 95% limits of agreement
Measured: Baseline (once the patient arrives at the emergency care unit and is included in the study).
Agreement between base concentration values obtained from veinous and arterial blood gas analyses in patients requiring a non-invasive ventilation due to an exacerbation of COPD or a cardiogenic APE.
Agreement between base concentration values obtained from veinous and arterial blood gas analyses, assessed using Bland-Altman analysis with mean bias and the 95% limits of agreement
Measured: Baseline (once the patient arrives at the emergency care unit and is included in the study).
Agreement between PCO2 values obtained from veinous and arterial blood gas analyses in patients with an exacerbation of COPD or a cardiogenic APE one hour after initiation of non-invasive ventilation.
Agreement between PCO2 values obtained from veinous and arterial blood gas analyses, assessed using Bland-Altman analysis with mean bias and the 95% limits of agreement
Measured: One hour after initiation of non-invasive ventilation.
Agreement between pH values obtained from veinous and arterial blood gas analyses in patients with an exacerbation of COPD or a cardiogenic APE one hour after initiation of non-invasive ventilation.
Agreement between pH values obtained from veinous and arterial blood gas analyses, assessed using Bland-Altman analysis with mean bias and the 95% limits of agreement
Measured: One hour after initiation of non-invasive ventilation.
Agreement between bicarbonate concentration values obtained from veinous and arterial blood gas analyses in patients with an exacerbation of COPD or a cardiogenic APE one hour after initiation of non-invasive ventilation.
Agreement between Bicarbonate concentration values obtained from veinous and arterial blood gas analyses, assessed using Bland-Altman analysis with mean bias and the 95% limits of agreement
Measured: One hour after initiation of non-invasive ventilation.
Agreement between base concentration values obtained from veinous and arterial blood gas analyses in patients with an exacerbation of COPD or a cardiogenic APE one hour after initiation of non-invasive ventilation.
Agreement between base concentration values obtained from veinous and arterial blood gas analyses, assessed using Bland-Altman analysis with mean bias and the 95% limits of agreement
Measured: One hour after initiation of non-invasive ventilation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2026
- Study start28 Sep 2026
- Primary completion24 Mar 2027 (estimated)
- Study completion24 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease (COPD), Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- 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
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07835945
- Sponsor's protocol ID
- 25-PP-13
- Acronym
- GAZOCAP
- Status last verified
- Oct 2026
- First submitted
- 17 Sep 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Arterial and Capillary Blood Gas Analyses in Patients With Respiratory Distress Due to COPD or APE
- ClinicalTrials.gov ID
- NCT07835945
- Acronym / sponsor ID
- GAZOCAP / 25-PP-13
- Keywords
- capillary blood gas analyses, arterial blood gas analyses, respiratory distress, COPD, APE
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 28 Sep 2026 (actual)
- Primary completion
- 24 Mar 2027 (estimated)
- Study completion
- 24 Mar 2027 (estimated)
- First posted
- 23 Sep 2026 (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 assessment of gas exchange is crucial for the management of patients suffering from respiratory distress due to an exacerbation of chronic obstructive pulmonary disease (COPD) or cardiogenic acute pulmonary edema (APE). These measurements are used by physicians to determine the need for noninvasive ventilation (NIV) as well as to evaluate its effectiveness and to decide whether to continue the treatment.
Arterial blood gas analysis is currently the gold standard for the measurement of these gas exchanges, though invasive, painful and risky (failure risks and possible local complications). Capillary blood gas analysis, which consists in collecting a blood drop from the ear or the finger by capillarity after punction, could represent a less invasive alternative. However, data comparing the performances of arterial and capillary blood gas analysis in the context of respiratory distress requiring a NIV remain limited.
This study is based on the hypothesis that capillary blood gas analysis can perform as well as arterial blood gas analysis. It is aimed at comparing values obtained from arterial and capillary blood gas analyses from patients with respiratory distress and requiring a NIV due to an exacerbation of COPD or cardiogenic APE.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Respiratory distress arm requiring a noninvasive ventilation | Experimental | Diagnostic Test: Capillary blood gas analysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients older than 18 years old
- Patients admitted in the emergency care unit with an exacerbation of COPD or a cardiogenic APE requiring a non-invasive ventilation (i.e. for COPD patients pH< 7.35, for APE patients: PCO2 > 45 mmHg)
- Patients affiliated to a social security system
Key exclusion criteria (7 listed)
- Patients for which a non-invasive ventilation was initiated upon pre-hospital care
- Contraindication for non-invasive ventilation
- Patients for which non-invasive ventilation is not indicated
- Patients for which capillary or arterial blood gas analyses are impossible
- Adults subject to legal guardianship (guardianship, conservatorship)
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 |
|---|---|---|
| Capillary blood gas analysisThe intervention consists in carrying out arterial, veinous and capillary blood gas analyses before submitting the patient to noninvasive ventilation (5 minutes will separate each sampling). Data from these samplings will be recorded. 1 hour after the implementation of the noninvasive ventilation, patients will once again undergo arterial, veinous and capillary samplings for blood gas analyses. Respiratory parameters will be recorded as well at the onset of the noninvasive ventilation and one hour after its start. | Diagnostic test | Respiratory distress arm requiring a noninvasive ventilation |
Primary outcome
Agreement between carbon dioxide pressure (PCO2) values obtained from capillary and arterial blood gas analyses in patients requiring a non-invasive ventilation due to an exacerbation of COPD or a cardiogenic APE.
Time frame: Baseline (once the patient arrives at the emergency care unit and is included in the study)
Agreement between arterial and capillary pCO₂ measurements, assessed using Bland-Altman analysis with mean bias and the 95% limits of agreement
15 secondary outcomes
Agreement between pH values obtained from capillary and arterial blood gas analyses in patients requiring a non-invasive ventilation due to an exacerbation of COPD or a cardiogenic APE
Time frame: Baseline (once the patient arrives at the emergency care unit and is included in the study)
Agreement between bicarbonate concentration values obtained from capillary and arterial blood gas analyses in patients requiring a non-invasive ventilation due to an exacerbation of COPD or a cardiogenic APE.
Time frame: Baseline (once the patient arrives at the emergency care unit and is included in the study)
Agreement between base concentration values obtained from capillary and arterial blood gas analyses in patients requiring a non-invasive ventilation due to an exacerbation of COPD or a cardiogenic APE.
Time frame: Baseline (once the patient arrives at the emergency care unit and is included in the study)
Agreement between PCO2 values obtained from capillary and arterial blood gas analyses in patients with an exacerbation of COPD or a cardiogenic APE one hour after initiation of non-invasive ventilation.
Time frame: One hour after initiation of non-invasive ventilation.
Agreement between pH values obtained from capillary and arterial blood gas analyses in patients with an exacerbation of COPD or a cardiogenic APE one hour after initiation of non-invasive ventilation.
Time frame: One hour after initiation of non-invasive ventilation.
Agreement between bicarbonate concentration values obtained from capillary and arterial blood gas analyses in patients with an exacerbation of COPD or a cardiogenic APE one hour after initiation of non-invasive ventilation.
Time frame: One hour after initiation of non-invasive ventilation.
Agreement between base concentration values obtained from capillary and arterial blood gas analyses in patients with an exacerbation of COPD or a cardiogenic APE one hour after initiation of non-invasive ventilation.
Time frame: One hour after initiation of non-invasive ventilation.
Agreement between PCO2 values obtained from veinous and arterial blood gas analyses in patients requiring a non-invasive ventilation due to an exacerbation of COPD or a cardiogenic APE.
Time frame: Baseline (once the patient arrives at the emergency care unit and is included in the study).
Agreement between pH values obtained from veinous and arterial blood gas analyses in patients requiring a non-invasive ventilation due to an exacerbation of COPD or a cardiogenic APE.
Time frame: Baseline (once the patient arrives at the emergency care unit and is included in the study).
Agreement between bicarbonate concentration values obtained from veinous and arterial blood gas analyses in patients requiring a non-invasive ventilation due to an exacerbation of COPD or a cardiogenic APE.
Time frame: Baseline (once the patient arrives at the emergency care unit and is included in the study).
Agreement between base concentration values obtained from veinous and arterial blood gas analyses in patients requiring a non-invasive ventilation due to an exacerbation of COPD or a cardiogenic APE.
Time frame: Baseline (once the patient arrives at the emergency care unit and is included in the study).
Agreement between PCO2 values obtained from veinous and arterial blood gas analyses in patients with an exacerbation of COPD or a cardiogenic APE one hour after initiation of non-invasive ventilation.
Time frame: One hour after initiation of non-invasive ventilation.
Agreement between pH values obtained from veinous and arterial blood gas analyses in patients with an exacerbation of COPD or a cardiogenic APE one hour after initiation of non-invasive ventilation.
Time frame: One hour after initiation of non-invasive ventilation.
Agreement between bicarbonate concentration values obtained from veinous and arterial blood gas analyses in patients with an exacerbation of COPD or a cardiogenic APE one hour after initiation of non-invasive ventilation.
Time frame: One hour after initiation of non-invasive ventilation.
Agreement between base concentration values obtained from veinous and arterial blood gas analyses in patients with an exacerbation of COPD or a cardiogenic APE one hour after initiation of non-invasive ventilation.
Time frame: One hour after initiation of non-invasive ventilation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Capillary blood gas analysis in people with Pulmonary Disease (COPD), Chronic Obstructive, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
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 3 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 2 Oct 2026. 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nathalie Ducot, MD-PhD (+33 (0)4 92 03 32 42, ducot.n@chu-nice.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement between carbon dioxide pressure (PCO2) values obtained from capillary and arterial blood gas analyses in patients requiring a non-invasive ventilation due to an exacerbation of COPD or a cardiogenic APE. (time frame: Baseline (once the patient arrives at the emergency care unit and is included in the study)). 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 2 Oct 2026; AzTrials last refreshed its copy on 8 Nov 2026.