Cardiac Output Monitoring by Transpulmonary Thermodilution and Transthoracic Echocardiography in Critically Ill Patients (TPTD-TTE-SR)

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

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.

Study Overview

• Status: Completed
• Conditions: Sinus Rhythm
• Intervention / Treatment: Other: Cardiac output measurement by transpulmonary thermodilution and transthoracic echocardiography

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 Type: Observational
• Enrollment (Actual): 36

Contacts and Locations

Study Locations

• France
  • Toulouse, France, 31000
    • University Hospital of Toulouse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Mechanically ventilated patients requiring hemodynamic assessment

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
mechanically ventilated and sedated patients with sinus rhythm; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
bias between cardiac output measurement by TPTD and by TTE	bias between cardiac output measurement by transthoracic echocardiography and transpulmonary thermodilution	Day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Antoine ROUGET, PH, University Hospital, Toulouse

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2020
• Primary Completion (Actual): February 10, 2021
• Study Completion (Actual): February 10, 2021

Study Registration Dates

• First Submitted: November 6, 2020
• First Submitted That Met QC Criteria: November 18, 2020
• First Posted (Actual): November 19, 2020

Study Record Updates

• Last Update Posted (Actual): June 1, 2021
• Last Update Submitted That Met QC Criteria: May 28, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Intensive care; Cardiac output monitoring; Transthoracic echocardiography; Transpulmonary thermodilution
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: RC31/19/0494; 2019-A03239-48 (Other Identifier: IDRCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No