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

This study is currently recruiting participants.
Verified June 2012 by Transonic Systems Inc.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Transonic Systems Inc.
ClinicalTrials.gov Identifier:
NCT01616017
First received: May 29, 2012
Last updated: June 6, 2012
Last verified: June 2012
History of Changes
  Purpose

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).


Condition
Cardiac Disease
Post Surgery Patients

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Comparison of Cardiac Output Measured by Ultrasound Dilution Method and Pulmonary Artery Thermodilution Technique

Resource links provided by NLM:

MedlinePlus related topics: Heart Diseases
U.S. FDA Resources

Further study details as provided by Transonic Systems Inc.:

Primary Outcome Measures:
  • Compare Cardiac Output Measurements [ Time Frame: During the stay in the ICU with in situ catheters (expected avg 3 days) ] [ Designated as safety issue: No ]
    To compare CO measured by ultrasound dilution method (COUD) and pulmonary artery thermodilution technique (COTD) in SICU patients.


Estimated Enrollment: 35
Study Start Date: May 2012
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01616017

Contacts
Contact: Mihae Yu, MD 808-586-2920 mihaey@hawaii.edu

Locations
United States, Hawaii
The Queen's Medical Center Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Mihae Yu, MD     808-586-2920     mihaey@hawaii.edu    
Sponsors and Collaborators
Transonic Systems Inc.
National Heart, Lung, and Blood Institute (NHLBI)
  More Information

No publications provided

Responsible Party: Transonic Systems Inc.
ClinicalTrials.gov Identifier: NCT01616017     History of Changes
Other Study ID Numbers: TSI-G-COstatus-11A-H, R44HL061994
Study First Received: May 29, 2012
Last Updated: June 6, 2012
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Transonic Systems Inc.:
Cardiac output
ultrasound dilution
thermodilution

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013