- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03524313
Assessment of Cardiac Output With EtCO2 (COCO2)
Assessment of Cardiac Output With End-tidal Carbon Monoxide
Hemodynamic monitoring, especially cardiac output assessment, is a key feature for the management of critically ill patients. Although the use of invasive methods, such as thermodilution with a pulmonary artery catheter, remains the GOLD standard for the evaluation of the cardiac output, several non-invasive techniques are currently used in practice. An acceptable estimation of the cardiac output can be made by standard transthoracic echocardiography. Cardiac output can be calculated from subaortic velocity time integral (VTI). However, this technique requires a trained operator and depends on the echogenicity of the patient. The best method for assessing cardiac output depends on the patient's needs, the clinical scenario and the physician's experience with the monitoring device itself. No simple and rapid tool currently exist for assessing cardiac output in critically ill patients.
The measurement of end-tidal carbon dioxide (EtCO2) used in routine in critically ill patients requiring mechanical ventilation could be an interesting alternative. Indeed, the amount of carbon dioxide (CO2) exhaled depends on the production of CO2 by the body, the pulmonary blood flow (corresponding to cardiac output) and its elimination by alveolar ventilation. In controlled ventilation, ie for constant alveolar ventilation, EtCO2 should therefore depend only on cardiac output. It has been shown in a porcine model that EtCO2 and cardiac output are strongly related under stable respiratory and metabolic conditions. In humans, only the variation of EtCO2 after volume expansion has been studied and EtCO2 seems to reflect changes in cardiac output. Nevertheless, the usefulness of EtCO2 in assessing cardiac output has never been evaluated.
The objective of this study is therefore to determine the relationship between EtCO2 and cardiac output evaluated by the measurement of subaortic VTI in critically ill patients.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
-
Besançon, France, 25000
- Recruiting
- Intensive care unit, University hospital of Besançon
-
Contact:
- Thibaud Soumagne, MD, PhD
- Phone Number: +33682535947
- Email: thibaud_soumagne@live.fr
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Contact:
- Gaël Piton, MD, PhD
- Phone Number: +33381668059
- Email: gpiton@chu-besancon.fr
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Sub-Investigator:
- Gaël Piton, MD, PhD
-
Principal Investigator:
- Thibaud Soumagne, MD, PhD
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Sub-Investigator:
- Hadrien Winiszewski, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- patients intubated and ventilated in the control assisted mode with no inspiratory effort
- requiring vasopressors
Exclusion Criteria:
- less than 18 years
- refuse to participate
- situation in which health condition, medication or procedure could significantly interfere with the interpretation of EtCO2 or cardiac output (extracorporeal life support, pneumothorax with persistant air leak)
(be increased without correlation to an infectious process (poly-traumatised patients,
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Correlation between cardiac output (VTI) and EtCO2
Time Frame: between 0 to 3 day after ICU admission
|
ITV ≈ (FR x EtCO2)/PaCO2
|
between 0 to 3 day after ICU admission
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Increase the sensitivity for detection of low cardiac output by using EtCO2
Time Frame: between 0 to 3 day after ICU admission
|
Estimate (development population) and validate (validation population) cut-off to detect low cardiac output by using EtCO2
|
between 0 to 3 day after ICU admission
|
Correlation between cardiac output (VTI) and portal veinous velocity
Time Frame: between 0 to 3 day after ICU admission
|
between 0 to 3 day after ICU admission
|
|
Comparison between cardiac output (VTI) and femoral veinous velocity
Time Frame: between 0 to 3 day after ICU admission
|
between 0 to 3 day after ICU admission
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Mercado P, Maizel J, Beyls C, Titeca-Beauport D, Joris M, Kontar L, Riviere A, Bonef O, Soupison T, Tribouilloy C, de Cagny B, Slama M. Transthoracic echocardiography: an accurate and precise method for estimating cardiac output in the critically ill patient. Crit Care. 2017 Jun 9;21(1):136. doi: 10.1186/s13054-017-1737-7.
- Long B, Koyfman A, Vivirito MA. Capnography in the Emergency Department: A Review of Uses, Waveforms, and Limitations. J Emerg Med. 2017 Dec;53(6):829-842. doi: 10.1016/j.jemermed.2017.08.026. Epub 2017 Oct 7.
- Weil MH, Bisera J, Trevino RP, Rackow EC. Cardiac output and end-tidal carbon dioxide. Crit Care Med. 1985 Nov;13(11):907-9. doi: 10.1097/00003246-198511000-00011.
- Monnet X, Bataille A, Magalhaes E, Barrois J, Le Corre M, Gosset C, Guerin L, Richard C, Teboul JL. End-tidal carbon dioxide is better than arterial pressure for predicting volume responsiveness by the passive leg raising test. Intensive Care Med. 2013 Jan;39(1):93-100. doi: 10.1007/s00134-012-2693-y. Epub 2012 Sep 19.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P/2018/367
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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