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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
Rijnstate Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cardiac Output, Low focused on measuring Cardiac output, TTE

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    February 25, 2021
    Last Updated
    February 25, 2021
    Sponsor
    Rijnstate Hospital
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    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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