Monitoring of the End-tidal Carbon Dioxide (EtCO2) as a Severity Criterion in COPD Exacerbations (CO2PD)

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.

Study Overview

• Status: Recruiting
• Conditions: Pulmonary Disease, Chronic Obstructive; Exacerbation Copd
• Intervention / Treatment: Diagnostic test: End-Tidal CO2 measurement during COPD exacerbation

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 Type: Observational
• Enrollment (Estimated): 240

Contacts and Locations

• Study Contact: Name: Nicolas Segond, MD; Phone Number: +33476766784; Email: nsegond@chu-grenoble.fr
• Study Contact Backup: Name: Prudence Mabiala Makele, PhD; Phone Number: +33476766784; Email: pmabialamakele@chu-grenoble.fr

Study Locations

• France
  • Isère
    • Grenoble, Isère, France, 38000
      • Recruiting
      • Chu Grenoble Alpes
      • Contact: Nicolas Segond, MD; Phone Number: +33476766784; Email: nsegond@chu-grenoble.fr
      • Contact: Prudence Mabiala Makele, PhD; Phone Number: +33476766784; Email: pmabialamakele@chu-grenoble.fr
      • Principal Investigator: Nicolas Segond, MD
      • Sub-Investigator: Damien Viglino, MD, PhD
  • Rhône
    • Lyon, Rhône, France, 69000
      • Recruiting
      • Hospices Civils de Lyon
      • Contact: Laurent Jacquin, MD; Phone Number: +33472110048; Email: laurent.jacquin@chu-lyon.fr
      • Principal Investigator: Laurent Jacquin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to emergency department for acute exacerbation of chronic obstructive pulmonary disease

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

Diagnostic test: End-Tidal CO2 measurement during COPD exacerbation; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Invasive or non-invasive ventilation (NIV) use (hour/min)	Invasive or non-invasive ventilation (NIV) use (hour/min)	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Arterial Blood Gaz measurement	PaCO2 and pH values	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.	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.	15 minutes (after emergency admission)

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble
• Collaborators: Hospices Civils de Lyon
• Investigators: Study Director: Damien VIGLINO, Prof. MD PhD, University Hospital, Grenoble; Principal Investigator: Nicolas SEGOND, MD, University Hospital, Grenoble

Publications and helpful links

General Publications

• Gamble 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.
• Lin LI. A concordance correlation coefficient to evaluate reproducibility. Biometrics. 1989 Mar;45(1):255-68.
• 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.
• Wang 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.
• Kartal 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.
• Jabre 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.
• Dogan 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.
• Tyagi 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.
• Bossuyt 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.

Helpful Links

• WHO Top 10 causes of death

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2023
• Primary Completion (Estimated): September 3, 2026
• Study Completion (Estimated): December 3, 2026

Study Registration Dates

• First Submitted: December 19, 2022
• First Submitted That Met QC Criteria: January 19, 2023
• First Posted (Actual): January 30, 2023

Study Record Updates

• Last Update Posted (Actual): April 15, 2026
• Last Update Submitted That Met QC Criteria: April 14, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Chronic Obstructive Pulmonary Disease; Capnography; COPD exacerbation
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pathological Conditions, Signs and Symptoms; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 38RC22.077; 2022-A02330-43 (Other Identifier: French ethics committees CPP Nord Ouest II)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

• IPD Sharing Time Frame: at the time of publication
• IPD Sharing Access Criteria: The international writing and publication rules (The Uniform Requirements for Manuscripts of the ICMJE, April 2010) will be followed. Moreover, In accordance with the French law n ° 2002-303 of March 4th, 2002
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No