Clinical trial NCT04637126: Cardiac Output Monitoring by Transpulmonary Thermodilution and Transthoracic Echocardiography in Critically Ill Patients
Official title: Cardiac Output Measurement in Critically Ill Patient in Sinus Rhythm: a Comparison Between Transpulmonary Thermodilution and Transthoracic Echocardiography
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sinus Rhythm
Keywords: Cardiac output monitoring
Transthoracic echocardiography
Transpulmonary thermodilution
Intensive care
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2020-11-19
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Mechanically ventilated patients requiring hemodynamic assessment

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.

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.

Primary outcomes:
measure: bias between cardiac output measurement by TPTD and by TTE
timeFrame: Day 0
Secondary outcomes:
measure: percentage error between cardiac output measurement by transthoracic echocardiography and transpulmonary thermodilution
timeFrame: Day 0
measure: 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.
timeFrame: 15 minutes after inclusion
measure: The ability of TPTD (transpulmonary thermodilution) to track Cardiac Output as measured with TTE (transthoracic echocardiography)
timeFrame: 15 minutes after inclusion
Other outcomes:
Locations:
city: Toulouse
country: France
facility: University Hospital of Toulouse
Study officials:
affiliation: University Hospital, Toulouse
name: Antoine ROUGET, PH
role: PRINCIPAL_INVESTIGATOR
References: