An observational study in Sinus Rhythm, sponsored by University Hospital, Toulouse. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-06-01.
Sponsored by University Hospital, Toulouse · Observational
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.
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.
1,881 studies on the registry are indexed under Critical Illness; 462 are open to participants now.
This study's enrollment of 36 is below the median of 130 across 867 observational studies indexed under Critical Illness.
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Mechanically ventilated patients requiring hemodynamic assessment
Exclusion Criteria:
all mechanically ventilated and sedated patients with sinus rhythm hospitalized in our ICU and fitted with an hemodynamic monitoring by thermodilution technique due to hemodynamic failure
Other: Cardiac output measurement by transpulmonary thermodilution and transthoracic echocardiography
Cardiac output is measured for all patients with transpulmonary thermodilution TPTD and transthoracic echocardiography TTE according to the recommendations
bias between cardiac output measurement by TPTD and by TTE
bias between cardiac output measurement by transthoracic echocardiography and transpulmonary thermodilution
Time frame: Day 0
percentage error between cardiac output measurement by transthoracic echocardiography and transpulmonary thermodilution
percentage error between cardiac output measurement by transthoracic echocardiography and transpulmonary thermodilution
Time frame: 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.
percentage error between the value of Cardiac Output measured with TTE and the value of Cardiac Output measured withTPTD after a fluid challenge.
Time frame: 15 minutes after inclusion
The ability of TPTD (transpulmonary thermodilution) to track Cardiac Output as measured with TTE (transthoracic echocardiography)
The ability of TPTD to track Cardiac Output as measured with TTE.
Time frame: 15 minutes after inclusion
Plan to share: No
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This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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University Hospital, Toulouse