Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2022-A02330-43 | Other Identifier | French ethics committees CPP Nord Ouest II |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Hospices Civils de Lyon | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient admitted for acute Exacerbation of Chronic Obstructive Pulmonary Disease | Patient admitted for acute Exacerbation of COPD. The measurement of EtCO2 will be performed at the emergency department |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Invasive or non-invasive ventilation (NIV) use (hour/min) | Invasive or non-invasive ventilation (NIV) use (hour/min) | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Arterial Blood Gaz measurement | PaCO2 and pH values | 15 minutes (after emergency admission) |
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients admitted to emergency department for acute exacerbation of chronic obstructive pulmonary disease
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nicolas SEGOND, MD | Contact | +33476766784 | nsegond@chu-grenoble.fr | |
| Prudence MABIALA MAKELE, PhD | Contact | +33476766784 | pmabialamakele@chu-grenoble.fr |
| Name | Affiliation | Role |
|---|---|---|
| Damien VIGLINO, Prof. MD PhD | University Hospital, Grenoble | Study Director |
| Nicolas SEGOND, MD | University Hospital, Grenoble | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Grenoble Alpes | Recruiting | Grenoble | Isère | 38000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26263032 | Background | 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. | |
| 34414969 | Background | 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. |
| Label | URL |
|---|---|
| WHO Top 10 causes of death | View source |
Not provided
The international writing and publication rules (The Uniform Requirements for Manuscripts of the ICMJE, April 2010) will be followed. The minimum anonymized source data for performing the statistical analysis will be made public at the time of publication, with the article, or deposited in an appropriate public database. Other anonymized data may be available from the principal investigator upon reasonable request and with the consent of the sponsor.
In accordance with the French law n ° 2002-303 of March 4th, 2002, the subjects can be informed, at their request, of the overall results of the research. In this study, the investigators commit to individually communicating the overall results to each subject participating in the research by a short (popularized) summary and associated with a copy of the scientific article.
at the time of publication
The international writing and publication rules (The Uniform Requirements for Manuscripts of the ICMJE, April 2010) will be followed. Moreover, In accordance with the French law n ° 2002-303 of March 4th, 2002
Not provided
Not provided
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 15 minutes (after emergency admission) |
| 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. | 15 minutes (after emergency admission) |
| Hospices Civils de Lyon | Recruiting | Lyon | Rhône | 69000 | France |
|
| 20224417 | Background | 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. |
| 19931750 | Background | 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. |
| 24560835 | Background | 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. |
| 33790512 | Background | 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. |
| 29260229 | Background | 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. |
| 26511519 | Background | 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. |
| 2720055 | Background | Lin LI. A concordance correlation coefficient to evaluate reproducibility. Biometrics. 1989 Mar;45(1):255-68. |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |