NCT03524313

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 9, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 14, 2018

Completed
1.6 years until next milestone

Study Start

First participant enrolled

January 1, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

January 31, 2020

Status Verified

December 1, 2019

Enrollment Period

1 year

First QC Date

April 9, 2018

Last Update Submit

January 30, 2020

Conditions

Keywords

cardiac outputend tidal carbon monoxideechocardiographyintensive care

Outcome Measures

Primary Outcomes (1)

  • Correlation between cardiac output (VTI) and EtCO2

    ITV ≈ (FR x EtCO2)/PaCO2

    between 0 to 3 day after ICU admission

Secondary Outcomes (3)

  • Increase the sensitivity for detection of low cardiac output by using EtCO2

    between 0 to 3 day after ICU admission

  • Correlation between cardiac output (VTI) and portal veinous velocity

    between 0 to 3 day after ICU admission

  • Comparison between cardiac output (VTI) and femoral veinous velocity

    between 0 to 3 day after ICU admission

Interventions

* 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

Also known as: Transthoracic echocardiography

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients \> 18 years intubated and ventilated in the control assisted mode with no inspiratory effort referred to the intensive unit.

You may qualify if:

  • patients intubated and ventilated in the control assisted mode with no inspiratory effort
  • requiring vasopressors

You may not qualify if:

  • 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,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Intensive care unit, University hospital of Besançon

Besançon, 25000, France

RECRUITING

Related Publications (4)

  • 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.

    PMID: 28595621BACKGROUND
  • 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.

    PMID: 28993038BACKGROUND
  • 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.

    PMID: 3931979BACKGROUND
  • 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.

    PMID: 22990869BACKGROUND

MeSH Terms

Interventions

Echocardiography

Intervention Hierarchy (Ancestors)

Cardiac Imaging TechniquesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisUltrasonographyHeart Function TestsDiagnostic Techniques, Cardiovascular

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2018

First Posted

May 14, 2018

Study Start

January 1, 2020

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

January 31, 2020

Record last verified: 2019-12

Locations