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

This study has been completed.
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: May 25, 2016
Last verified: May 2016
  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:


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 (Surgical Intensive Care Unit) patients.


Enrollment: 39
Study Start Date: May 2012
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01616017

Locations
United States, Hawaii
The Queen's Medical Center
Honolulu, Hawaii, United States, 96813
Sponsors and Collaborators
Transonic Systems Inc.
National Heart, Lung, and Blood Institute (NHLBI)
  More Information

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: May 25, 2016
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 September 26, 2016