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Recruiting NCT05704881

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

— Observational Pulmonary Disease, Chronic Obstructive Exacerbation Copd

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: End-Tidal CO2 measurement during COPD exacerbation.
Who it may be relevant to
Registry conditions: Pulmonary Disease, Chronic Obstructive, Exacerbation Copd. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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

Primary outcome measures

  • Invasive or non-invasive ventilation (NIV) use (hour/min) [Time frame: 24 hours]
Secondary outcome measures (3)
  • 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)]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

France · 2 centers
  • CHU Grenoble Alpes — Grenoble
  • Hospices Civils de Lyon — Lyon

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. PMID 26263032
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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

Identifiers

NCT: NCT05704881 · 38RC22.077 · 2022-A02330-43

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗