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

Completed

• Conditions: Sinus Rhythm
• Interventions: Other: Cardiac output measurement by transpulmonary thermodilution and transthoracic echocardiography

• Registration Number: NCT04637126
• Lead Sponsor: University Hospital, Toulouse

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.

Study Timeline

• Study Start: 2020-03-06
• Study First Submitted: 2020-11-06
• Study First Submitted QC: 2020-11-18
• Study First Posted: 2020-11-19
• Primary Completion: 2021-02-10
• Study Completion: 2021-02-10
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-28
• Last Update Posted: 2021-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
mechanically ventilated and sedated patients with sinus rhythm	Cardiac output measurement by transpulmonary thermodilution and transthoracic echocardiography	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

Primary Outcome Measures

Name	Time	Method
bias between cardiac output measurement by TPTD and by TTE	Day 0	bias between cardiac output measurement by transthoracic echocardiography and transpulmonary thermodilution

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Hospital of Toulouse; 🇫🇷 Toulouse, France