Comparison of Cardiac Output Measured by Ultrasound Dilution Method and Pulmonary Artery Thermodilution Technique

May 25, 2016 updated by: Transonic Systems Inc.
Cardiac output (CO) is an important hemodynamic variable in the management of critically ill patients. The pulmonary artery catheter (PAC) requires invasive techniques with potential complications and there is increasing interest in less invasive methods of measuring CO. This study is designed to compare CO values from PAC thermodilution (COTD) and ultrasound dilution (COUD).

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

39

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
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • The Queen's Medical Center

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 to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Age ≥ 18 years of age Presence of arterial catheter plus central venous pressure monitor and pulmonary artery catheter for hemodynamic monitoring.

Description

Inclusion Criteria:

  • Age ≥ 18 years of age
  • Presence of arterial catheter plus central venous pressure monitor and pulmonary artery catheter for hemodynamic monitoring.

Exclusion Criteria:

  • Age < 18 years of age
  • Patients with structurally abnormal heart (e.g. shunt) (confirmed by history taking)
  • Patients who have heparin allergy. (Confirmed by history taking)

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

  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare Cardiac Output Measurements
Time Frame: During the stay in the ICU with in situ catheters (expected avg 3 days)
To compare CO measured by ultrasound dilution method (COUD) and pulmonary artery thermodilution technique (COTD) in SICU (Surgical Intensive Care Unit) patients.
During the stay in the ICU with in situ catheters (expected avg 3 days)

Collaborators and Investigators

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

Sponsor

Transonic Systems Inc.

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

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

May 1, 2012

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

May 29, 2012

First Submitted That Met QC Criteria

June 6, 2012

First Posted (Estimate)

June 11, 2012

Study Record Updates

Last Update Posted (Estimate)

May 27, 2016

Last Update Submitted That Met QC Criteria

May 25, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TSI-G-COstatus-11A-H
  • R44HL061994 (U.S. NIH Grant/Contract)

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.

Clinical Trials on Cardiac Disease

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Türkiye

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe