Measurement of Cardiac Output and Blood Volumes Using Transonic Ultrasound Dilution Technology

Measurement of Cardiac Output and Blood Volumes Using Transonic Ultrasound Dilution Technology - Clinical Evaluation and Validation

Measurement of the amount of blood pumped by the heart (cardiac output) and blood volumes in sick patients is important for doctors to better treat these patients. Current procedures available demand difficult invasive procedures and hence these parameters are not measured with enough frequency and are also limited to certain patients. The new COstatus system is capable of using the already existing arterial and venous lines placed in critically ill patients and thus provides an opportunity to measure these parameters less invasively and with enough frequency.

The purpose of this study is to measure cardiac output and blood volumes using ultrasound dilution technology (COstatus system)in post cardiac surgery adult patients and compare the cardiac output measurements with a current clinical reference method, thermodilution.

Study Overview

• Status: Completed
• Conditions: Post Cardiac Surgery Patients

• Study Type: Observational
• Enrollment (Actual): 26

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 119992
    • National Research Center of Surgery, Russian Academy of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Post cardiac surgery adult patients

Description

Inclusion Criteria:

• Post cardiac surgery adult patients
• Patients with heart catheter and arterial catheter

Exclusion Criteria:

Study Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: Transonic Systems Inc.
• Collaborators: Russian Academy of Medical Sciences
• Investigators: Principal Investigator: Alexsandr A Eremenko, MD, Russian Academy of Medical Sciences

Publications and helpful links

General Publications

• Eremenko A, Balykov I, Chaus N, Kislukhin V, Krivitski N. Use of an extracorporeal arteriovenous tubing loop to measure cardiac output in intensive care unit patients by ultrasound velocity dilution. ASAIO J. 1998 Sep-Oct;44(5):M462-4. doi: 10.1097/00002480-199809000-00028.
• Eremenko AA, Chaus NI, Kislukhin VV, Balykov IV. [The determination of cardiac output by the dilution of ultrasonic blood density]. Anesteziol Reanimatol. 1998 Jul-Aug;(4):4-6. Russian.
• Krivitski NM, Kislukhin VV, Thuramalla NV. Theory and in vitro validation of a new extracorporeal arteriovenous loop approach for hemodynamic assessment in pediatric and neonatal intensive care unit patients. Pediatr Crit Care Med. 2008 Jul;9(4):423-8. doi: 10.1097/01.PCC.0b013e31816c71bc.

Study record dates

Study Major Dates

• Study Start: December 1, 2006
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: September 17, 2008
• First Submitted That Met QC Criteria: September 18, 2008
• First Posted (Estimate): September 19, 2008

Study Record Updates

• Last Update Posted (Estimate): May 31, 2012
• Last Update Submitted That Met QC Criteria: May 30, 2012
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Other Study ID Numbers: TSI-R-COstatus-1A-H