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

This study has been completed.

Sponsor:

Collaborator:

Russian Academy of Medical Sciences

Information provided by (Responsible Party):

Transonic Systems Inc.

ClinicalTrials.gov Identifier:

NCT00756119

First received: September 17, 2008

Last updated: May 30, 2012

Last verified: May 2012

History of Changes

Purpose

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.

Condition
Post Cardiac Surgery Patients

Study Type:	Observational
Study Design:	Observational Model: Case-Only Time Perspective: Prospective
Official Title:	Measurement of Cardiac Output and Blood Volumes Using Transonic Ultrasound Dilution Technology - Clinical Evaluation and Validation

Resource links provided by NLM:

MedlinePlus related topics: Heart Surgery

U.S. FDA Resources

Further study details as provided by Transonic Systems Inc.:

Enrollment:	26
Study Start Date:	December 2006
Study Completion Date:	December 2009
Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Post cardiac surgery adult patients

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00756119

Locations

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

Sponsors and Collaborators

Transonic Systems Inc.

Russian Academy of Medical Sciences

Investigators

Principal Investigator:

Alexsandr A Eremenko, MD

Russian Academy of Medical Sciences

More Information

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.

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 May 19; [Epub ahead of print]

Responsible Party:	Transonic Systems Inc.
ClinicalTrials.gov Identifier:	NCT00756119 History of Changes
Other Study ID Numbers:	TSI-R-COstatus-1A-H
Study First Received:	September 17, 2008
Last Updated:	May 30, 2012
Health Authority:	Russia: Ethics Committee

ClinicalTrials.gov processed this record on May 19, 2013

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