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

NCT05704881 | Recruiting

• 2 other identifiers: 38RC22.0772022-A02330-43
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Exacerbation Copd; Pulmonary Disease, Chronic Obstructive

Keywords

Chronic Obstructive Pulmonary Disease; Capnography; COPD exacerbation

Outcome Measures

Primary Outcomes (1)

• Invasive or non-invasive ventilation (NIV) use (hour/min)

  Invasive or non-invasive ventilation (NIV) use (hour/min)

  24 hours

Secondary Outcomes (3)

• Arterial Blood Gaz measurement

  15 minutes (after emergency admission)

• Concordance between EtCO2 (mmHg) and PaCO2 (mmHg) using Bland and Altman graphical method.

  15 minutes (after emergency admission)

• Concordance between EtCO2 (mmHg) and PvCO2 (mmHg) using Bland and Altman graphical method.

  15 minutes (after emergency admission)

Study Arms (1)

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

Interventions

End-Tidal CO2 measurement during COPD exacerbation DIAGNOSTIC_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.

Patient admitted for acute Exacerbation of Chronic Obstructive Pulmonary Disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Grenoble: lead
• Hospices Civils de Lyon: collaborator

Study Sites (2)

CHU Grenoble Alpes

Grenoble, Isère, 38000, France

RECRUITING

Hospices Civils de Lyon

Lyon, Rhône, 69000, France

RECRUITING

Related Publications (9)

• 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.

  PMID: 26263032 BACKGROUND

• 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.

  PMID: 34414969 BACKGROUND

• 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.

  PMID: 20224417 BACKGROUND

• 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.

  PMID: 19931750 BACKGROUND

• 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.

  PMID: 24560835 BACKGROUND

• 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.

  PMID: 33790512 BACKGROUND

• 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.

  PMID: 29260229 BACKGROUND

• 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.

  PMID: 26511519 BACKGROUND

• Lin LI. A concordance correlation coefficient to evaluate reproducibility. Biometrics. 1989 Mar;45(1):255-68.

  PMID: 2720055 BACKGROUND

Related Links

• WHO Top 10 causes of death

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Damien VIGLINO, Prof. MD PhD

  University Hospital, Grenoble

  STUDY DIRECTOR

• Nicolas SEGOND, MD

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicolas SEGOND, MD

CONTACT

+33476766784; nsegond@chu-grenoble.fr

Prudence MABIALA MAKELE, PhD

CONTACT

+33476766784; pmabialamakele@chu-grenoble.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2022
• First Posted: January 30, 2023
• Study Start: March 3, 2023
• Primary Completion (Estimated): September 3, 2026
• Study Completion (Estimated): December 3, 2026
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: at the time of publication
• 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

Locations

FR (2)