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Clinical Trials/NCT04637126
NCT04637126
Completed
Not Applicable

Cardiac Output Measurement in Critically Ill Patient in Sinus Rhythm: a Comparison Between Transpulmonary Thermodilution and Transthoracic Echocardiography

University Hospital, Toulouse1 site in 1 country36 target enrollmentMarch 6, 2020
ConditionsSinus Rhythm

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sinus Rhythm
Sponsor
University Hospital, Toulouse
Enrollment
36
Locations
1
Primary Endpoint
bias between cardiac output measurement by TPTD and by TTE
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

Cardiac output monitoring is a key component for the diagnosis and management of critically ill patients. The two less invasive methods commonly used in intensive care are transthoracic echocardiography and transpulmonary thermodilution. The objective of this study is to compare accuracy and trending ability of CO measurement by TPTD and TTE in critically ill patients with sinus rhythm.

Detailed Description

TTE is an easy noninvasive device now recommended as the first evaluation of the patient in circulatory failure but it present some limits due to poor echogenicity of patients, operator-dependent variability and cannot provide continuous hemodynamic data. TPTD is an invasive technique for CO monitoring recommended especially in shock not responsive to initial therapy. Few studies have evaluated the level of agreement of each method (TTE and TPTD) with the reference method (pulmonary artery catheter) but they have never been compared between them with strong statistical analysis in particular trending ability. It could be interesting to determine the level of concordance of these two methods of CO monitoring and trend ability by TPTD relative to TTE. The investigators hypothesize that CO-TPTD are concordant with those performed by TTE. Mechanically ventilated patients requiring hemodynamic assessment will be included. CO-TPTD will be measured via intermittent thermodilution. Blindly, a second investigator will use standard-view TTE to estimate CO-TTE as the product of stroke volume and the heart rate obtained during the measurement the blood flow velocity (using a Doppler technique) at the left ventricular outflow tract. A second measurement will be done with the two devices after a fluid challenge when patient requires it to compare trending ability.

Registry
clinicaltrials.gov
Start Date
March 6, 2020
End Date
February 10, 2021
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • mechanically ventilated and sedated patients
  • with sinus rhythm
  • hospitalized in Intensive Care Unit
  • fitted with an hemodynamic monitoring by thermodilution technique due to hemodynamic failure

Exclusion Criteria

  • age under 18
  • arrhythmia
  • severe aortic regurgitation or stenosis
  • intracardiac shunt
  • poor echogenicity
  • tamponade
  • major subject to a legal protection regim.

Outcomes

Primary Outcomes

bias between cardiac output measurement by TPTD and by TTE

Time Frame: Day 0

bias between cardiac output measurement by transthoracic echocardiography and transpulmonary thermodilution

Secondary Outcomes

  • percentage error between cardiac output measurement by transthoracic echocardiography and transpulmonary thermodilution(Day 0)
  • percentage error between the value of Cardiac Output measured with TTE (transthoracic echocardiography) and the value of Cardiac Output measured withTPTD (transpulmonary thermodilution) after a fluid challenge.(15 minutes after inclusion)
  • The ability of TPTD (transpulmonary thermodilution) to track Cardiac Output as measured with TTE (transthoracic echocardiography)(15 minutes after inclusion)

Study Sites (1)

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