Real-time Continuous Cardiac Output Measurements

Overview

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

Full Title of Study: “Real-time Automatic Continuous Cardiac Output Measurements Using Transthoracic Echocardiography (TTE) in ICU-patients in Comparison to Flotrac Measurements”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 1, 2022

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

Interventions

  • Device: TTE
    • Transthoracic echocardiography

Arms, Groups and Cohorts

  • Experimental: Cardiac output measurements
    • Cardiac output will be measured using TTE continuously with ProbeFix

Clinical Trial Outcome Measures

Primary Measures

  • Patients in which the ProbeFix can be used continuously
    • Time Frame: 2 months
    • Percentages will be reported

Secondary Measures

  • Correlation between continuous TTE and Flotrac
    • Time Frame: 2 months
    • Bland-Altman plot will be reported

Participating in This Clinical Trial

Inclusion Criteria

  • Adult Intensive Care patients ( > 18 years) Exclusion Criteria:

  • Pregnancy – Atrial fibrillation or other irregular heart rhythm

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Rijnstate Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • B Baten, 088 – 0057870, BBaten@rijnstate.nl

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