NCT04637126

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 6, 2020

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 6, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 19, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2021

Completed
Last Updated

June 1, 2021

Status Verified

May 1, 2021

Enrollment Period

11 months

First QC Date

November 6, 2020

Last Update Submit

May 28, 2021

Conditions

Sinus Rhythm

Keywords

Cardiac output monitoringTransthoracic echocardiographyTranspulmonary thermodilutionIntensive care

Outcome Measures

Primary Outcomes (1)

  • bias between cardiac output measurement by TPTD and by TTE

    bias between cardiac output measurement by transthoracic echocardiography and transpulmonary thermodilution

    Day 0

Secondary Outcomes (3)

  • 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.

    15 minutes after inclusion

  • The ability of TPTD (transpulmonary thermodilution) to track Cardiac Output as measured with TTE (transthoracic echocardiography)

    15 minutes after inclusion

Study Arms (1)

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

Interventions

Cardiac output measurement by transpulmonary thermodilution and transthoracic echocardiographyOTHER

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

mechanically ventilated and sedated patients with sinus rhythm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Mechanically ventilated patients requiring hemodynamic assessment

You may qualify if:

  • 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

You may not qualify if:

  • age under 18
  • arrhythmia
  • severe aortic regurgitation or stenosis
  • intracardiac shunt
  • poor echogenicity
  • tamponade
  • major subject to a legal protection regim.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Toulouse

Toulouse, 31000, France

Location

Study Officials

  • Antoine ROUGET, PH

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2020

First Posted

November 19, 2020

Study Start

March 6, 2020

Primary Completion

February 10, 2021

Study Completion

February 10, 2021

Last Updated

June 1, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)