Real-time Continuous Cardiac Output Measurements
Primary Purpose
Cardiac Output, Low
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
TTE
Sponsored by
About this trial
This is an interventional diagnostic trial for Cardiac Output, Low focused on measuring Cardiac output, TTE
Eligibility Criteria
Inclusion Criteria:
- Adult Intensive Care patients ( > 18 years)
Exclusion Criteria:
- Pregnancy
- Atrial fibrillation or other irregular heart rhythm
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cardiac output measurements
Arm Description
Cardiac output will be measured using TTE continuously with ProbeFix
Outcomes
Primary Outcome Measures
Patients in which the ProbeFix can be used continuously
Percentages will be reported
Secondary Outcome Measures
Correlation between continuous TTE and Flotrac
Bland-Altman plot will be reported
Full Information
NCT ID
NCT04774978
First Posted
February 25, 2021
Last Updated
February 25, 2021
Sponsor
Rijnstate Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04774978
Brief Title
Real-time Continuous Cardiac Output Measurements
Official Title
Real-time Automatic Continuous Cardiac Output Measurements Using Transthoracic Echocardiography (TTE) in ICU-patients in Comparison to Flotrac Measurements
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2021 (Anticipated)
Primary Completion Date
March 1, 2022 (Anticipated)
Study Completion Date
July 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rijnstate Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Study to assess the feasibility of real-time automatic cardiac output measurements using transthoracic echocardiography (TTE)
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Output, Low
Keywords
Cardiac output, TTE
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cardiac output measurements
Arm Type
Experimental
Arm Description
Cardiac output will be measured using TTE continuously with ProbeFix
Intervention Type
Device
Intervention Name(s)
TTE
Intervention Description
Transthoracic echocardiography
Primary Outcome Measure Information:
Title
Patients in which the ProbeFix can be used continuously
Description
Percentages will be reported
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Correlation between continuous TTE and Flotrac
Description
Bland-Altman plot will be reported
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult Intensive Care patients ( > 18 years)
Exclusion Criteria:
Pregnancy
Atrial fibrillation or other irregular heart rhythm
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
B Baten
Phone
088 - 0057870
Email
BBaten@rijnstate.nl
12. IPD Sharing Statement
Learn more about this trial
Real-time Continuous Cardiac Output Measurements
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