Noninvasive Cardiac Output Monitoring in Pulmonary Hypertension

March 8, 2022 updated by: Santa Barbara Cottage Hospital
Comparison of Ultrasonic Cardiac Output Monitor (USCOM) system with Fick and thermodilution methods during right heart catheterization in patients with pulmonary hypertension.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Santa Barbara, California, United States, 93105
        • Santa Barbara Cottage Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Age > 18 years
  • Diagnosis of Group 1 or Group 4 PAH based on PAPm > 25 mmHg, PAWP <15 mmHg, PVR >3 WU and consistent clinical history. Note: for logistical reasons, patients at high suspicion for Group 1 or Group 4 PAH will sign informed consent to have the USCOM system applied during right heart catheterization before the procedure; if it is found that the patient does not meet the definition of Group 1 or Group 4 PAH during right heart catheterization, he/she will be excluded.
  • Willingness and ability to comply with study procedures.
  • No known hypersensitivity to the components of USCOM electrodes

Exclusion criteria:

  • Unwillingness to sign informed consent or inability or unwillingness to comply with study procedures
  • Evidence of postcapillary pulmonary hypertension on right heart catheterization

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: USCOM
Device: Ultrasonic Cardiac Output Monitor (USCOM) system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiac output measurement correlation at baseline
Time Frame: 30 minutes
Correlation between cardiac output measurement between USCOM system and Fick and thermodilution methods of cardiac output measurement (standard of care)
30 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiac output measurement correlation after vasodilator testing
Time Frame: 30 minutes
Correlation between cardiac output measurement between USCOM system and Fick and thermodilution methods of cardiac output measurement (standard of care) after vasodilator trial testing
30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Santa Barbara Cottage Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2016

Primary Completion (Actual)

October 1, 2020

Study Completion (Actual)

October 1, 2021

Study Registration Dates

First Submitted

October 27, 2016

First Submitted That Met QC Criteria

October 28, 2016

First Posted (Estimate)

November 1, 2016

Study Record Updates

Last Update Posted (Actual)

March 10, 2022

Last Update Submitted That Met QC Criteria

March 8, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-61

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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