Clinical trial NCT05704881: Monitoring of the End-tidal Carbon Dioxide (EtCO2) as a Severity Criterion in COPD Exacerbations
Official title: Monitoring of the End-tidal Carbon Dioxide (EtCO2 ) as a Severity Criterion in COPD Exacerbations: a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pulmonary Disease, Chronic Obstructive
Exacerbation Copd
Keywords: Chronic Obstructive Pulmonary Disease
Capnography
COPD exacerbation
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: Hospices Civils de Lyon
First posted: 2023-01-30
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to emergency department for acute exacerbation of chronic obstructive pulmonary disease

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.

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.

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)

Primary outcomes:
measure: Invasive or non-invasive ventilation (NIV) use (hour/min)
timeFrame: 24 hours
Secondary outcomes:
measure: Arterial Blood Gaz measurement
timeFrame: 15 minutes (after emergency admission)
measure: Concordance between EtCO2 (mmHg) and PaCO2 (mmHg) using Bland and Altman graphical method.
timeFrame: 15 minutes (after emergency admission)
measure: Concordance between EtCO2 (mmHg) and PvCO2 (mmHg) using Bland and Altman graphical method.
timeFrame: 15 minutes (after emergency admission)
Other outcomes:
Locations:
city: Grenoble
country: France
facility: CHU Grenoble Alpes
state: Isère
city: Lyon
country: France
facility: Hospices Civils de Lyon
state: Rhône
Study officials:
affiliation: University Hospital, Grenoble
name: Damien VIGLINO, Prof. MD PhD
role: STUDY_DIRECTOR
affiliation: University Hospital, Grenoble
name: Nicolas SEGOND, MD
role: PRINCIPAL_INVESTIGATOR
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