Cardiac Output Monitoring by Transpulmonary Thermodilution and Transthoracic Echocardiography in Critically Ill Patients

Sinus Rhythm Clinical Trial

— TPTD-TTE-SR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04637126
• Other study ID #: RC31/19/0494
• Secondary ID: 2019-A03239-48
• Status: Completed
• Start date: March 6, 2020
• Est. completion date: February 10, 2021

Study information

• Verified date: May 2021
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: February 10, 2021
• Est. primary completion date: February 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Critical Illness
• Sinus Rhythm

Intervention

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

Locations

Country	Name	City	State
France	University Hospital of Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	bias between cardiac output measurement by TPTD and by TTE	bias between cardiac output measurement by transthoracic echocardiography and transpulmonary thermodilution	Day 0
Secondary	percentage error between cardiac output measurement by transthoracic echocardiography and transpulmonary thermodilution	percentage error between cardiac output measurement by transthoracic echocardiography and transpulmonary thermodilution	Day 0
Secondary	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.	15 minutes after inclusion
Secondary	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.	15 minutes after inclusion