Pulmonary Disease, Chronic ObstructiveCO2PDNCT05704881
Monitoring of the End-tidal Carbon Dioxide (EtCO2) as a Severity Criterion in COPD Exacerbations
An observational study of Pulmonary Disease, Chronic Obstructive and Exacerbation Copd, run by University Hospital, Grenoble at 2 sites in France.
Trial summary
Although we know that these numbers are underestimated, Chronic obstructive pulmonary disease (COPD) is a common chronic respiratory disease that affects between 8 and 12% of adults. According to a 2020 WHO report, it is the third most common cause of mortality in developed countries. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive, Exacerbation Copd
- What is being tested?
- End-Tidal CO2 measurement during COPD exacerbation
- How many people
- 240 participants
- Where
- 2 sitesFrance
- Study dates
- 3 Mar 2023to 3 Dec 2026
- Phase
- Observational
- 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
Study population: Patients admitted to emergency department for acute exacerbation of chronic obstructive pulmonary disease
Who may be able to join
- All patient presenting to the emergency department with acute dyspnea and with a history of COPD documented or reported by the patient and/or family
- Male or female≥18 years old who did not oppose to participating in the study
Who cannot join
- Hypotension (SBP < 90 mmHg or MBP < 65 mmHg)
- Patient already included in the study during a previous visit to the emergency department
- Patient already ventilated with invasive or NIV during admission to the emergency department
- COPD exacerbation rejected after medical and additional examinations
- Non-communicative or non-French speaking patients, or with impaired comprehension, or with impaired consciousness
- Protected persons referred to in articles L1121-6 and L1121-8 of French public health code (deprived of liberty, tutorship or curatorship)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
CHU Grenoble Alpes
Grenoble, Isère, 38000
Nicolas Segond, MD, +33476766784, nsegond@chu-grenoble.fr
Prudence Mabiala Makele, PhD, +33476766784, pmabialamakele@chu-grenoble.fr
- Recruiting
Hospices Civils de Lyon
Lyon, Rhône, 69000
Laurent Jacquin, MD, +33472110048, laurent.jacquin@chu-lyon.fr
Laurent Jacquin
About this study
Official title: Monitoring of the End-tidal Carbon Dioxide (EtCO2 ) as a Severity Criterion in COPD Exacerbations: a Prospective Observational Study
Although we know that these numbers are underestimated, Chronic obstructive pulmonary disease (COPD) is a common chronic respiratory disease that affects between 8 and 12% of adults. According to a 2020 WHO report, it is the third most common cause of mortality in developed countries. This disease is punctuated by exacerbations associated with an 8% mortality of hospitalized patients, increased to 24% when the patient is admitted to intensive care unit. Early detection and treatment of these exacerbations appears to be essential to improve patient survival. End-tidal carbon dioxide (EtCO2) is used to assess a patient's respiratory and hemodynamic status. Indeed, EtCO2 is a non-invasive measure that could allow the estimation of arterial carbon dioxide (PaCO2) without performing blood gases, an arterial blood sampling, classically at the radial artery. This study aimed to find an EtCO2 value which at the time of the initial management, would be predictive of a severe COPD exacerbation, as well as PaCO2.
Read the detailed description
The study will be conducted in the emergency departments of Grenoble and Lyon University Hospitals.
Patients will be recruited by the dispatch nurse at the emergency department reception according to the inclusion and non-inclusion criteria. The EtCO2 will be measured at the emergency reception during assessment of vital signs by the same nurse with the help of a mask or oxygen glasses measuring EtCO2. The patient will then be treated conventionally according to current international recommendations. The physician in charge of the patient will be blinded to this measurement. Once the patient is discharged from the emergency department, the primary and secondary endpoints will be collected by a clinical research associate 24 hours after admission from medical record.
- Being tested
- End-Tidal CO2 measurement during COPD exacerbation
- Keywords
- Chronic Obstructive Pulmonary Disease, Capnography, COPD exacerbation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
End-Tidal CO2 measurement during COPD exacerbationDiagnostic test
The EtCO2 will be measured at the emergency reception during assessment of vital signs by the nurse with the help of a mask or oxygen glasses measuring EtCO2. The patient will then be treated conventionally according to current international recommendations. The physician in charge of the patient will be blinded to this measurement. The outcome will be the initiation of invasive or non-invasive ventilation (NIV) within the first 24 hours of admission to the emergency department, as indicated by the physician in charge of the patient.
| Study group | Role | What they receive |
|---|---|---|
| Patient admitted for acute Exacerbation of Chronic Obstructive Pulmonary Disease | Patient admitted for acute Exacerbation of COPD. The measurement of EtCO2 will be performed at the emergency department Receives: Diagnostic Test: End-Tidal CO2 measurement during COPD exacerbation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Invasive or non-invasive ventilation (NIV) use (hour/min)
Invasive or non-invasive ventilation (NIV) use (hour/min)
Measured: 24 hours
Secondary outcomes (3)
Arterial Blood Gaz measurement
PaCO2 and pH values
Measured: 15 minutes (after emergency admission)
Concordance between EtCO2 (mmHg) and PaCO2 (mmHg) using Bland and Altman graphical method.
A Bland and Altman graph will be used to estimate the concordance between values of EtCO2 (mmHg) and PaCO2 (mmHg) measured on the first blood gases sample performed in the emergency department.
Measured: 15 minutes (after emergency admission)
Concordance between EtCO2 (mmHg) and PvCO2 (mmHg) using Bland and Altman graphical method.
A Bland and Altman graph will be used to estimate the concordance between values of EtCO2 (mmHg) and PvCO2 (mmHg) measured on the first venous blood sample performed in the emergency department.
Measured: 15 minutes (after emergency admission)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2023
- Study start3 Mar 2023
- Primary completion3 Sep 2026 (estimated)
- Study completion3 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- Hospices Civils de Lyon
- Responsible party
- Sponsor
- Investigators
- Damien VIGLINO, Prof. MD PhD, Study director, University Hospital, GrenobleNicolas SEGOND, MD, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05704881
- Sponsor's protocol ID
- 38RC22.077
- Other IDs
- 2022-A02330-43
- Acronym
- CO2PD
- Status last verified
- Apr 2026
- First submitted
- 19 Dec 2022
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The international writing and publication rules (The Uniform Requirements for Manuscripts of the ICMJE, April 2010) will be followed. The minimum anonymized source data for performing the statistical analysis will be made public at the time of publication, with the article, or deposited in an appropriate public database. Other anonymized data may be available from the principal investigator upon reasonable request and with the consent of the sponsor. In accordance with the French law n ° 2002-303 of March 4th, 2002, the subjects can be informed, at their request, of the overall results of the research. In this study, the investigators commit to individually communicating the overall results to each subject participating in the research by a short (popularized) summary and associated with a copy of the scientific article.
Publications
Molinari N, Briand C, Vachier I, Malafaye N, Aubas P, Georgescu V, Roche N, Chanez P, Bourdin A. Hospitalizations for COPD Exacerbations: Trends and Determinants of Death. COPD. 2015;12(6):621-7. doi: 10.3109/15412555.2015.1007931. Epub 2015 Aug 11.
PubMed 26263032Wang J, Zhang J, Liu Y, Shang H, Peng L, Cui Z. Relationship between end-tidal carbon dioxide and arterial carbon dioxide in critically ill patients on mechanical ventilation: A cross-sectional study. Medicine (Baltimore). 2021 Aug 20;100(33):e26973. doi: 10.1097/MD.0000000000026973.
PubMed 34414969Kartal M, Goksu E, Eray O, Isik S, Sayrac AV, Yigit OE, Rinnert S. The value of ETCO2 measurement for COPD patients in the emergency department. Eur J Emerg Med. 2011 Feb;18(1):9-12. doi: 10.1097/MEJ.0b013e328337b9b9.
PubMed 20224417Jabre P, Jacob L, Auger H, Jaulin C, Monribot M, Aurore A, Margenet A, Marty J, Combes X. Capnography monitoring in nonintubated patients with respiratory distress. Am J Emerg Med. 2009 Nov;27(9):1056-9. doi: 10.1016/j.ajem.2008.08.017.
PubMed 19931750Dogan NO, Sener A, Gunaydin GP, Icme F, Celik GK, Kavakli HS, Temrel TA. The accuracy of mainstream end-tidal carbon dioxide levels to predict the severity of chronic obstructive pulmonary disease exacerbations presented to the ED. Am J Emerg Med. 2014 May;32(5):408-11. doi: 10.1016/j.ajem.2014.01.001. Epub 2014 Jan 15.
PubMed 24560835Tyagi D, Govindagoudar MB, Jakka S, Chandra S, Chaudhry D. Correlation of PaCO2 and ETCO2 in COPD Patients with Exacerbation on Mechanical Ventilation. Indian J Crit Care Med. 2021 Mar;25(3):305-309. doi: 10.5005/jp-journals-10071-23762.
PubMed 33790512Gamble C, Krishan A, Stocken D, Lewis S, Juszczak E, Dore C, Williamson PR, Altman DG, Montgomery A, Lim P, Berlin J, Senn S, Day S, Barbachano Y, Loder E. Guidelines for the Content of Statistical Analysis Plans in Clinical Trials. JAMA. 2017 Dec 19;318(23):2337-2343. doi: 10.1001/jama.2017.18556.
PubMed 29260229Bossuyt PM, Reitsma JB, Bruns DE, Gatsonis CA, Glasziou PP, Irwig L, Lijmer JG, Moher D, Rennie D, de Vet HC, Kressel HY, Rifai N, Golub RM, Altman DG, Hooft L, Korevaar DA, Cohen JF; STARD Group. STARD 2015: an updated list of essential items for reporting diagnostic accuracy studies. BMJ. 2015 Oct 28;351:h5527. doi: 10.1136/bmj.h5527.
PubMed 26511519Lin LI. A concordance correlation coefficient to evaluate reproducibility. Biometrics. 1989 Mar;45(1):255-68.
PubMed 2720055
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring of the End-tidal Carbon Dioxide (EtCO2 ) as a Severity Criterion in COPD Exacerbations: a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT05704881
- Acronym / sponsor ID
- CO2PD / 38RC22.077
- Keywords
- Chronic Obstructive Pulmonary Disease, Capnography, COPD exacerbation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- Hospices Civils de Lyon
- Study start
- 3 Mar 2023 (actual)
- Primary completion
- 3 Sep 2026 (estimated)
- Study completion
- 3 Dec 2026 (estimated)
- First posted
- 30 Jan 2023 (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.
Although we know that these numbers are underestimated, Chronic obstructive pulmonary disease (COPD) is a common chronic respiratory disease that affects between 8 and 12% of adults. According to a 2020 WHO report, it is the third most common cause of mortality in developed countries. This disease is punctuated by exacerbations associated with an 8% mortality of hospitalized patients, increased to 24% when the patient is admitted to intensive care unit. Early detection and treatment of these exacerbations appears to be essential to improve patient survival. End-tidal carbon dioxide (EtCO2) is used to assess a patient's respiratory and hemodynamic status. Indeed, EtCO2 is a non-invasive measure that could allow the estimation of arterial carbon dioxide (PaCO2) without performing blood gases, an arterial blood sampling, classically at the radial artery. This study aimed to find an EtCO2 value which at the time of the initial management, would be predictive of a severe COPD exacerbation, as well as PaCO2.
Detailed description
The study will be conducted in the emergency departments of Grenoble and Lyon University Hospitals.
Patients will be recruited by the dispatch nurse at the emergency department reception according to the inclusion and non-inclusion criteria. The EtCO2 will be measured at the emergency reception during assessment of vital signs by the same nurse with the help of a mask or oxygen glasses measuring EtCO2. The patient will then be treated conventionally according to current international recommendations. The physician in charge of the patient will be blinded to this measurement. Once the patient is discharged from the emergency department, the primary and secondary endpoints will be collected by a clinical research associate 24 hours after admission from medical record.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient admitted for acute Exacerbation of Chronic Obstructive Pulmonary Disease | – | Diagnostic Test: End-Tidal CO2 measurement during COPD exacerbationPatient admitted for acute Exacerbation of COPD. The measurement of EtCO2 will be performed at the emergency department |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to emergency department for acute exacerbation of chronic obstructive pulmonary disease
Key inclusion criteria (2 listed)
- All patient presenting to the emergency department with acute dyspnea and with a history of COPD documented or reported by the patient and/or family
- Male or female≥18 years old who did not oppose to participating in the study
Key exclusion criteria (6 listed)
- Hypotension (SBP < 90 mmHg or MBP < 65 mmHg)
- Patient already included in the study during a previous visit to the emergency department
- Patient already ventilated with invasive or NIV during admission to the emergency department
- COPD exacerbation rejected after medical and additional examinations
- Non-communicative or non-French speaking patients, or with impaired comprehension, or with impaired consciousness
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 |
|---|---|---|
| End-Tidal CO2 measurement during COPD exacerbationThe EtCO2 will be measured at the emergency reception during assessment of vital signs by the nurse with the help of a mask or oxygen glasses measuring EtCO2. The patient will then be treated conventionally according to current international recommendations. The physician in charge of the patient will be blinded to this measurement. The outcome will be the initiation of invasive or non-invasive ventilation (NIV) within the first 24 hours of admission to the emergency department, as indicated by the physician in charge of the patient. | Diagnostic test | Patient admitted for acute Exacerbation of Chronic Obstructive Pulmonary Disease |
Primary outcome
Invasive or non-invasive ventilation (NIV) use (hour/min)
Time frame: 24 hours
Invasive or non-invasive ventilation (NIV) use (hour/min)
3 secondary outcomes
Arterial Blood Gaz measurement
Time frame: 15 minutes (after emergency admission)
Concordance between EtCO2 (mmHg) and PaCO2 (mmHg) using Bland and Altman graphical method.
Time frame: 15 minutes (after emergency admission)
Concordance between EtCO2 (mmHg) and PvCO2 (mmHg) using Bland and Altman graphical method.
Time frame: 15 minutes (after emergency admission)
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 15 Apr 2026.
- Background: PubMed 26263032Molinari N, Briand C, Vachier I, Malafaye N, Aubas P, Georgescu V, Roche N, Chanez P, Bourdin A. Hospitalizations for COPD Exacerbations: Trends and Determinants of Death. COPD. 2015;12(6):621-7. doi: 10.3109/15412555.2015.1007931. Epub 2015 Aug 11.
- Background: PubMed 34414969Wang J, Zhang J, Liu Y, Shang H, Peng L, Cui Z. Relationship between end-tidal carbon dioxide and arterial carbon dioxide in critically ill patients on mechanical ventilation: A cross-sectional study. Medicine (Baltimore). 2021 Aug 20;100(33):e26973. doi: 10.1097/MD.0000000000026973.
- Background: PubMed 20224417Kartal M, Goksu E, Eray O, Isik S, Sayrac AV, Yigit OE, Rinnert S. The value of ETCO2 measurement for COPD patients in the emergency department. Eur J Emerg Med. 2011 Feb;18(1):9-12. doi: 10.1097/MEJ.0b013e328337b9b9.
- Background: PubMed 19931750Jabre P, Jacob L, Auger H, Jaulin C, Monribot M, Aurore A, Margenet A, Marty J, Combes X. Capnography monitoring in nonintubated patients with respiratory distress. Am J Emerg Med. 2009 Nov;27(9):1056-9. doi: 10.1016/j.ajem.2008.08.017.
- Background: PubMed 24560835Dogan NO, Sener A, Gunaydin GP, Icme F, Celik GK, Kavakli HS, Temrel TA. The accuracy of mainstream end-tidal carbon dioxide levels to predict the severity of chronic obstructive pulmonary disease exacerbations presented to the ED. Am J Emerg Med. 2014 May;32(5):408-11. doi: 10.1016/j.ajem.2014.01.001. Epub 2014 Jan 15.
- Background: PubMed 33790512Tyagi D, Govindagoudar MB, Jakka S, Chandra S, Chaudhry D. Correlation of PaCO2 and ETCO2 in COPD Patients with Exacerbation on Mechanical Ventilation. Indian J Crit Care Med. 2021 Mar;25(3):305-309. doi: 10.5005/jp-journals-10071-23762.
- Background: PubMed 29260229Gamble C, Krishan A, Stocken D, Lewis S, Juszczak E, Dore C, Williamson PR, Altman DG, Montgomery A, Lim P, Berlin J, Senn S, Day S, Barbachano Y, Loder E. Guidelines for the Content of Statistical Analysis Plans in Clinical Trials. JAMA. 2017 Dec 19;318(23):2337-2343. doi: 10.1001/jama.2017.18556.
- Background: PubMed 26511519Bossuyt PM, Reitsma JB, Bruns DE, Gatsonis CA, Glasziou PP, Irwig L, Lijmer JG, Moher D, Rennie D, de Vet HC, Kressel HY, Rifai N, Golub RM, Altman DG, Hooft L, Korevaar DA, Cohen JF; STARD Group. STARD 2015: an updated list of essential items for reporting diagnostic accuracy studies. BMJ. 2015 Oct 28;351:h5527. doi: 10.1136/bmj.h5527.
- Background: PubMed 2720055Lin LI. A concordance correlation coefficient to evaluate reproducibility. Biometrics. 1989 Mar;45(1):255-68.
- WHO Top 10 causes of deathLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. The international writing and publication rules (The Uniform Requirements for Manuscripts of the ICMJE, April 2010) will be followed. The minimum anonymized source data for performing the statistical analysis will be made public at the time of publication, with the article, or deposited in an appropriate public database. Other anonymized data may be available from the principal investigator upon reasonable request and with the consent of the sponsor. In accordance with the French law n ° 2002-303 of March 4th, 2002, the subjects can be informed, at their request, of the overall results of the research. In this study, the investigators commit to individually communicating the overall results to each subject participating in the research by a short (popularized) summary and associated with a copy of the scientific article.
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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.
Damien VIGLINO, Prof. MD PhD study director
University Hospital, Grenoble
Nicolas SEGOND, MD principal investigator
University Hospital, Grenoble
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Disease, Chronic Obstructive and Exacerbation Copd, run by University Hospital, Grenoble at 2 sites 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 2 inclusion and 6 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 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Nicolas SEGOND, MD (+33476766784, nsegond@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Invasive or non-invasive ventilation (NIV) use (hour/min) (time frame: 24 hours). 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 NCT05704881, which also lists 9 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 15 Apr 2026.