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NCT Number: NCT05704881

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Grenoble Alpes, Grenoble, Isère, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 24 hours

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

Secondary outcomes

  1. Arterial Blood Gaz measurement

    Time frame: 15 minutes (after emergency admission)

    PaCO2 and pH values

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

    Time frame: 15 minutes (after emergency admission)

    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.

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

    Time frame: 15 minutes (after emergency admission)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Nicolas SEGOND, MD

CONTACT

[email protected]

+33476766784

Prudence MABIALA MAKELE, PhD

CONTACT

[email protected]

+33476766784

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Collaborators

  • Hospices Civils de Lyon

Registry information

Official study title

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

Acronym: CO2PD

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jan 30, 2023
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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