Real-time Continuous Cardiac Output Measurements

Sponsor

Rijnstate Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04774978

Collaborator

(none)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Study to assess the feasibility of real-time automatic cardiac output measurements using transthoracic echocardiography (TTE)

Condition or Disease	Intervention/Treatment	Phase
Cardiac Output, Low	Device: TTE	N/A

Detailed Description

Rationale: Study to assess the feasibility of real-time automatic cardiac output measurements using transthoracic echocardiography (TTE)

Objective: To assess the correlation and feasibility of real-time automatic continuous cardiac output measurements using transthoracic ultrasound (TTE) in adult ICU-patients in comparison to Flotrac measurements

Study design: prospective, feasibility study

Study population: Adult Intensive Care patients ( > 18 years)

Intervention (if applicable):

Consecutive adult patients on the ICU in which the there is an indication for continuous cardiac output measurements.

Main study parameters/endpoints:

Percentage of patients in which continuous cardiac output can be measured using TTE
Correlation between continuous TTE and Flotrac measurements

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Real-time Automatic Continuous Cardiac Output Measurements Using Transthoracic Echocardiography (TTE) in ICU-patients in Comparison to Flotrac Measurements

Anticipated Study Start Date :

Mar 1, 2021

Anticipated Primary Completion Date :

Mar 1, 2022

Anticipated Study Completion Date :

Jul 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cardiac output measurements Cardiac output will be measured using TTE continuously with ProbeFix	Device: TTE Transthoracic echocardiography

Arm

Intervention/Treatment

Experimental: Cardiac output measurements

Cardiac output will be measured using TTE continuously with ProbeFix

Device: TTE

Transthoracic echocardiography

Outcome Measures

Primary Outcome Measures

Patients in which the ProbeFix can be used continuously [2 months]
Percentages will be reported

Secondary Outcome Measures

Correlation between continuous TTE and Flotrac [2 months]
Bland-Altman plot will be reported

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Adult Intensive Care patients ( > 18 years)

Exclusion Criteria:

Pregnancy
Atrial fibrillation or other irregular heart rhythm

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Rijnstate Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Rijnstate Hospital

ClinicalTrials.gov Identifier:

NCT04774978

Other Study ID Numbers:

RijnstateH

First Posted:

Mar 1, 2021

Last Update Posted:

Mar 1, 2021

Last Verified:

Feb 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Yes

Keywords provided by Rijnstate Hospital

Cardiac output

TTE

Additional relevant MeSH terms:

Cardiac Output, Low

Study Results

No Results Posted as of Mar 1, 2021