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

Recruiting

• Conditions: Pulmonary Disease, Chronic Obstructive; Exacerbation Copd
• Interventions: Diagnostic Test: End-Tidal CO2 measurement during COPD exacerbation

• Registration Number: NCT05704881
• Lead Sponsor: University Hospital, Grenoble

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.

Study Timeline

• Study First Submitted: 2022-12-19
• Study First Submitted QC: 2023-01-19
• Study First Posted: 2023-01-30
• Study Start: 2023-03-03
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-13
• Last Update Posted: 2024-05-14
• Primary Completion: 2025-02-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 240

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patient admitted for acute Exacerbation of Chronic Obstructive Pulmonary Disease	End-Tidal CO2 measurement during COPD exacerbation	Patient admitted for acute Exacerbation of COPD. The measurement of EtCO2 will be performed at the emergency department

Primary Outcome Measures

Name	Time	Method
Invasive or non-invasive ventilation (NIV) use (hour/min)	24 hours	Invasive or non-invasive ventilation (NIV) use (hour/min)

Secondary Outcome Measures

Name	Time	Method
Arterial Blood Gaz measurement	15 minutes (after emergency admission)	PaCO2 and pH values
Concordance between EtCO2 (mmHg) and PaCO2 (mmHg) using Bland and Altman graphical method.	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.
Concordance between EtCO2 (mmHg) and PvCO2 (mmHg) using Bland and Altman graphical method.	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.

Trial Locations

Locations (2)

CHU Grenoble Alpes; 🇫🇷 Grenoble, Isère, France

Hospices Civils de Lyon; 🇫🇷 Lyon, Rhône, France