Post Cardiac Surgery Patients Clinical Trial
Official title:
Measurement of Cardiac Output and Blood Volumes Using Transonic Ultrasound Dilution Technology - Clinical Evaluation and Validation
| Verified date | May 2012 |
| Source | Transonic Systems Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Russia: Ethics Committee |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 26 |
| Est. completion date | December 2009 |
| Est. primary completion date | December 2009 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 21 Years and older |
| Eligibility |
Inclusion Criteria: - Post cardiac surgery adult patients - Patients with heart catheter and arterial catheter Exclusion Criteria: |
Observational Model: Case-Only, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Russian Federation | National Research Center of Surgery, Russian Academy of Medical Sciences | Moscow |
| Lead Sponsor | Collaborator |
|---|---|
| Transonic Systems Inc. | Russian Academy of Medical Sciences |
Russian Federation,
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. — View Citation
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. — View Citation
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. — View Citation