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

NCT ID: NCT04637126

Last Updated: 2021-06-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

36 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-06

Study Completion Date

2021-02-10

Brief Summary

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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

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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.

Conditions

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Sinus Rhythm

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Cardiac output measurement by transpulmonary thermodilution and transthoracic echocardiography

Intervention Type OTHER

Cardiac output is measured for all patients with transpulmonary thermodilution TPTD and transthoracic echocardiography TTE according to the recommendations

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Toulouse

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Antoine ROUGET, PH

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

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University Hospital of Toulouse

Toulouse, , France

Site Status

Countries

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France

Other Identifiers

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2019-A03239-48

Identifier Type: OTHER

Identifier Source: secondary_id

RC31/19/0494

Identifier Type: -

Identifier Source: org_study_id

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