Monitoring of the End-tidal Carbon Dioxide (EtCO2) as a Severity Criterion in COPD Exacerbations
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Grenoble
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Patients admitted to emergency department for acute exacerbation of chronic obstructive pulmonary disease
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
End-Tidal CO2 measurement during COPD exacerbation
Diagnostic testThe 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.
Treatment groups
240 Participants
are divided into 1 treatment groupGroup A: Patient admitted for acute Exacerbation of Chronic Obstructive Pulmonary Disease1 intervention
Trial outcomes
Primary outcomes
1
Invasive or non-invasive ventilation (NIV) use (hour/min)
Invasive or non-invasive ventilation (NIV) use (hour/min)
Time frame
24 hoursSecondary outcomes
1
Arterial Blood Gaz measurement
PaCO2 and pH values
Time frame
15 minutes (after emergency admission)2
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.
Time frame
15 minutes (after emergency admission)3
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.
Time frame
15 minutes (after emergency admission)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospital, Grenoble
Lead sponsor
Hospices Civils de Lyon
Collaborator
Source ClinicalTrials.gov