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

Cardiac Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01616017
• Other study ID #: TSI-G-COstatus-11A-H
• Secondary ID: R44HL061994
• Status: Completed
• Phase: N/A
• First received: May 29, 2012
• Last updated: May 25, 2016
• Start date: May 2012
• Est. completion date: May 2013

Study information

• Verified date: May 2016
• Source: Transonic Systems Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Observational

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 100 Years

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiac Disease
• Heart Diseases
• Post Surgery Patients

Locations

Country	Name	City	State
United States	The Queen's Medical Center	Honolulu	Hawaii

Sponsors (2)

Lead Sponsor	Collaborator
Transonic Systems Inc.	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare Cardiac Output Measurements	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)	No