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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03524313
Other study ID # P/2018/367
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2020
Est. completion date December 31, 2020

Study information

Verified date December 2019
Source Centre Hospitalier Universitaire de Besancon
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 75
Est. completion date December 31, 2020
Est. primary completion date December 31, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
End tidal carbon monoxide
Evaluation of cardiac output estimated by transthoracic echocardiography and end tidal carbon monoxide Evaluation of cardiac output estimated by transthoracic echocardiography and portal veinous velocity Evaluation of femoral veinous velocity

Locations

Country Name City State
France Intensive care unit, University hospital of Besançon Besançon

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

References & Publications (4)

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. Review. — View Citation

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. — View Citation

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. — View Citation

Weil MH, Bisera J, Trevino RP, Rackow EC. Cardiac output and end-tidal carbon dioxide. Crit Care Med. 1985 Nov;13(11):907-9. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Correlation between cardiac output (VTI) and EtCO2 ITV ˜ (FR x EtCO2)/PaCO2 between 0 to 3 day after ICU admission
Secondary Increase the sensitivity for detection of low cardiac output by using EtCO2 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
Secondary Correlation between cardiac output (VTI) and portal veinous velocity between 0 to 3 day after ICU admission
Secondary Comparison between cardiac output (VTI) and femoral veinous velocity between 0 to 3 day after ICU admission
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