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

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Besançon, France, 25000
        • Recruiting
        • Intensive care unit, University hospital of Besançon
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Gaël Piton, MD, PhD
        • Principal Investigator:
          • Thibaud Soumagne, MD, PhD
        • Sub-Investigator:
          • Hadrien Winiszewski, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-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.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2020

Primary Completion (ANTICIPATED)

December 31, 2020

Study Completion (ANTICIPATED)

December 31, 2020

Study Registration Dates

First Submitted

April 9, 2018

First Submitted That Met QC Criteria

May 2, 2018

First Posted (ACTUAL)

May 14, 2018

Study Record Updates

Last Update Posted (ACTUAL)

January 31, 2020

Last Update Submitted That Met QC Criteria

January 30, 2020

Last Verified

December 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Cardiac Output

Clinical Trials on End tidal carbon monoxide

3
Subscribe